In-House On-Site Seminars, Training Classes and Workshops

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 Are You Being Heard? Onsite Training

 

Category: ACCOUNTING

Give your staff the communication skills they need to get their point across.


 

 3063 GroupWise 7.0 Administration

 

Category: COMPUTERS / IT

In this course, students learn the skills to install, implement, and administer a GroupWise 7 messaging and collaboration system for internal and external communication.


 

 3938 Updating Your Skills from Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 to Microsoft Exchange Server 2007

 

Category: COMPUTERS / IT

This course provides Exchange 2000 Server or Microsoft Exchange Server 2003 administrators with skills needed to manage a Microsoft Exchange Server 2007 infrastructure. The course focuses on new features and administrative tasks in Exchange Server 2007.


 

 A Comprehensive View of FDA Regulations for Medical Devices: 2 - Day In-Person Seminar

 

Category: Compliance-Regulation

The seminar will help you understand the four major parts of the US regulatory structure: laws regulations, guidance, and consensus standards. Risk class and the panels, established by law, characterize medical devices in the US.


 

 A Practical Guide to Federal Court: E-Discovery, Evidence and Experts

 

Category: LAW - Federal Litigation

Learn how to strategically apply key federal rules to the most critical aspects of your case.


 

 A Risk Based Scientific Approach to Analytical Methods Development and Validation Activities for FDA Regulated Industries

 

Category: Compliance-Regulation

This Course is highly interactive and participative. Attendees are encouraged to interact and be prepared to bring examples of Analytical Development and Validation issues, which will be discussed during the second day.


 

 Administrative Assistants Professionals Conference

 

Category: ADMINISTRATIVE PROFESSIONALS

You work hard every day. You deserve this amazing opportunity to learn, grow, and share with other great professionals just like you!


 

 Advanced Estate and Trust Administration

 

Category: LAW - Elder Law / Estate Planning

Get expert guidance on tough inventory issues, trust administration, claims and insolvency, taxes, and many more. Increase your legal mastery


 

 Advanced Medicaid and Medicare Benefits Update

 

Category: LAW - Medical

Gain practical tips for Medicaid and Medicare hearings and appeals and find out how the courts have been shaping the practice.


 

 AEG's Finance & Accounting Fundamentals

 

Category: ACCOUNTING - Fundamentals

This course stresses the fundamentals of finance and accounting skills for the non financial person, financial analysis, and current accounting developments. The emphasis is on Fun as the concepts are presented in a relaxed and enjoyable manner with extensive practice opportunities.


 

 AMA’s 5-Day MBA Program

 

Category: EXECUTIVE EDUCATION

An intensive, week-long learning experience that gives you a thorough grounding in the essential elements of a high-level MBA program.


 

 Analytical Instrument Qualification and System Validation

 

Category: Compliance-Regulation

This will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use.


 

 Anatomy and Independent Medical Evaluations 101 for Attorneys

 

Category: LAW

Don't miss this opportunity to augment your legal knowledge with an anatomy primer straight from medical professionals.


 

 Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management

 

Category: Compliance-Regulation

Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.


 

 Applying Medical Knowledge of Injuries to Your Case

 

Category: LAW - Medical

This unique panel of experts will overlay real-world plaintiff and defense legal strategies with anatomical diagrams, injury causation, treatment options and more.


 

 Aseptic Processing Overview and Validation: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.


 

 Auditing for Medical Device and Pharma Companies

 

Category: Compliance-Regulation

2-day seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system.it is an incredibly powerful tool to identify areas of non-compliance.


 

 Australian Regulatory Guidelines for Medical Devices (ARGMD): Government Reimbursement, Requirements, Fees and Turnaround Time to Product Approval: 2-Day Workshop

 

Category: Compliance-Regulation

The Australian regulatory and reimbursement agency have particular requirements in their assessments of applications for Medical Devices intended for supply in Australia.


 

 Bad Things Happen, But It Can Get Worse - Understanding FDA Post Market Regulations

 

Category: Compliance-Regulation

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that has only been offered by Casper Uldriks and Rita Hoffman, who bring over 68 years of combined experience.


 

 Best in Class Wage & Hour Compliance: The Federal Labor Standards Act (FLSA)

 

Category: Compliance-Regulation

Your participation in this seminar will assist you in ensuring wage and hour laws are being followed properly in your organization.


 

 Best Practices for HR Assistants

 

Category: ADMINISTRATIVE PROFESSIONALS

This seminar is jam-packed with great ideas, proven strategies, and powerhouse techniques to help you successfuly navigate the sometimes turbulent waters of human resources. It will help you effectively and efficiently support your department and be a reliable and professional advocate for your organization and its employees. You'll accomplish your job with less stress, fewer slipups and blunders, and greater satisfaction and enjoyment.Best Practices for Personnel/HR Assistants focuses on time-tested best practices — information and guidelines reccomended by human resources experts and successfully applied by companies both large and small across the nation. You'll also learn up-to-date tips and strategies that will help you confidently maneuver through the potential minefields of government regulations and employment law.Whether you are new to HR or have some experience under your belt, you'll walk away with the essential skills, knowledge, and insight every HR professional needs to handle all of the complexities of this challenging, rewarding field.


 

 Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices

 

Category: Compliance-Regulation

The mission of the Food and Drug Administration is “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.”


 

 Bioanalytical Methods and Good Laboratory Practices (GLP) - Essential Elements for Pre-Clinical Studies during development of Drugs

 

Category: Compliance-Regulation

This course will discuss in details the use and validation of bioanalytical methods. For clinical evaluation of drugs, bioanalytical methods and other methods, such as biological assays, immunochemical assays, etc. are used.


 

 Biocompatibility Testing for Medical Devices

 

Category: Compliance-Regulation

Attendees will understand and apply ISO 10993-1 and the FDA Guidance on its use. They will know how to use the ISO documents to locate information that you need. Understand what tests to select and how to choose among various options.


 

 Building a Vendor Qualification Program for FDA Regulated Industries: One and Half Day In-Person Seminar

 

Category: Compliance-Regulation

This course will provide valuable assistance and guidance to all FDA regulated companies for building sustainable vendor qualification program


 

 CA&PA for Medical Devices

 

Category: Compliance-Regulation

This interactive two-day course provides the tools you need to develop and implement an effective medical device CA&PA system.


 

 Cal/OSHA Compliance

 

Category: SECURITY/SAFETY

Discover dozens of cost-effective ways for getting your organization into compliance, learn how to expand the effectiveness of your safety training program, find out how to keep the meticulous records required by Cal/OSHA, and learn how to assess your organization for a variety of hazards.


 

 CDISC Mapping and Strategies Implemented: 2-Day In-person Seminar

 

Category: Compliance-Regulation

This two day workshop teaches essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE). Examples of both SDTM and ADaM dataset structures will be reviewed and compared.


 

 Certificate Program in FMLA & ADA Compliance - HR Law

 

Category: HR MGMT

Discover vital employment law knowledge, critical strategies to perfect your HR skills, and earn your certificate in FMLA, ADA, GINA compliance and best practices!


 

 CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

This course begins by studying important concepts about the role and scope of quality and compliance and the resulting activities as quality and compliance work in multi-functional teams to achieve product safety and efficacy.


 

 Change Control Best Practices - Avoiding Unintended Consequences of Changes: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

The seminar will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc. Document change control will be discussed as a supporting element.


 

 China & Pacific Rim Markets : Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

 

Category: Compliance-Regulation

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China and the listed Pacific Rim Countries.


 

 Cisco® Call Manager Basic Administration

 

Category: COMPUTERS / IT

This course provides the foundation of a Cisco IP Telephony network solution. This course is designed to provide the level one (on-site) support staff the skills needed to add, move, and change IP Telephony devices using Cisco Call Manager


 

 Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

 

Category: Compliance-Regulation

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.


 

 CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA

 

Category: Compliance-Regulation

FDA has granted precious few applications for waiver since their CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial.


 

 Clinical Data Management (FDA E6 GCP Guidelines): 2-Day In-Person Seminar

 

Category: LAW - Medical

This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan.


 

 Clinical Trial Essentials; Implementation Best Practice

 

Category: Compliance-Regulation

This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP). Participants will acquire real-world application of GCP regulations and guidelines for critical elements of the clinical research and development process. This training includes the updates brought by the ICH E6 R2 Addendum.


 

 Collections Law

 

Category: ACCOUNTING - Credit/Collection

In this comprehensive one-day seminar, you'll discover information, strategies, and techniques to help you collect debts more swiftly, protect your assets more effectively, and minimize the risk of costly lawsuits, fines, and judgments being levied against you.


 

 Comparison of Connecticut State and Federal Rules of Procedure and Evidence

 

Category: LAW - Federal Litigation

Let our team of experienced litigators and court clerks guide you in a comparative analysis of state and federal civil procedure and offer practical tips for applying the rules to ensure your cases' smooth travel through the court corridors.


 

 Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products

 

Category: Compliance-Regulation

Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation.


 

 ComplianceOnline Pharma Summit 2016 – Risk Control and Compliance

 

Category: Compliance-Regulation

This summit will provide a venue for industry experts, policymakers, manufacturers, inventors and clinician to discuss and debate these challenges as well as explore new strategies and opportunities for growth.


 

 Computer System Validation - Reduce Costs and Avoid 483s

 

Category: Compliance-Regulation

This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.


 

 Contracting Officer's Representative (COR) Level I

 

Category: GOVERNMENT

This hands-on course provides the training necessary for FAC-COR Level I certification and provides practical and relevant interactive course material and methodologies.


 

 Corrective and Preventative Action Topics: Investigation Phase, Action Phase and Verification of Effectiveness Phase

 

Category: Compliance-Regulation

While the focus of this workshop is toward the medical device and pharmaceutical industries, the problem solving methodologies outlined in this course are not limited to CAPA projects. While general CAPA language will be utilized in the course, the methodologies described in this workshop are universal to solving problems across most industries.


 

 Creating Reader-Focused Technical Documents in FDA Regulated Industries

 

Category: Compliance-Regulation

Advanced technology may have pushed effective communication to the wayside to make clear writing a lost art, now due for revival! In the Information Age, a surplus of technical data proliferates with very little information communicated in plain language.


 

 CTX-1220 Citrix MetaFrame XP 1.0 for Windows Administration

 

Category: COMPUTERS / IT

This course provides the necessary foundation to fully utilize the power of the Citrix MetaFrame XP products and will prepare administrators to expertly perform Citrix MetaFrame XP installations and administrative tasks.


 

 CTX-1259AI Citrix Presentation Server 4.5: Administration

 

Category: COMPUTERS / IT

This course provides training for installing Citrix Presentation Server and Presentation Server Clients and using the various administrative consoles to configure published resources, policies, individual server and server farm settings.


 

 CTX-1327AI Citrix Password Manager 4.5: Administration

 

Category: COMPUTERS / IT

This course introduces administrators and IT professionals to Citrix Password Manager 4.5 and prepares them to install, administer and support the product.


 

 Data Integrity, Good Documentation Practices and Electronic Data Governance

 

Category: Compliance-Regulation

Three interactive modules that tackle the requirements and the discipline needed to consistently manually document and electronically record the manufacturing & testing of APIs, Drug Formulations, Biosimilars and Vaccines DATA INTEGRITY MEANS Manual Entries


 

 Data Integrity: FDA, WHO and EMA's Requirements: 2-Day In-person Seminar

 

Category: Compliance-Regulation

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters.


 

 Data Integrity: FDA/EMA Requirements and Implementation

 

Category: Compliance-Regulation

The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance.


 

 Data Integrity: FDA/EU Requirements and Implementation

 

Category: Compliance-Regulation

There is no doubt that data integrity is the current and future inspection focus of all regulatory heath care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations.


 

 Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration

 

Category: Compliance-Regulation

During this seminar, the Theory of Lean Documents and its corollary applied to lean configuration will be applied in order to construct, write, and configure the types of documents and records necessary for medical device design and manufacturing.


 

 Designing and Sustaining New and Existing Product Stability Testing Program

 

Category: Compliance-Regulation

This seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical.


 

 Dirty Litigation Tactics: How to Deal with the 'Rambo' Litigator

 

Category: LAW

Use the Federal Rules of Civil Procedure to Neutralize Scorched Earth Tactics


 

 Discovery Under the New Federal Rules of Civil Procedure

 

Category: LAW - Discovery

Learn how to apply the proportionality standard, new guidelines on spoliation and more to your next case.


 

 Drug Dissolution Testing and Establishing Plasma Drug Levels in Humans

 

Category: Compliance-Regulation

This is a unique in-depth seminar on the subject not available anywhere else with unmatched coverage of scientific details and addressing regulatory and compendial requirements yet extremely simple to understand.


 

 Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation

 

Category: Compliance-Regulation

The Drug Master File (DMF) is a valuable repository of confidential information which can be stored at the FDA by a product manufacturer in the pharmaceutical industry.


 

 Effective Design, Validation and Routine Maintenance of Pharmaceutical Gases: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

Pharmaceutical gases such as Compressed, Nitrogen Argon gas systems used for the production of finished pharmaceutical or other types of products may either have direct or indirect impact to the finished products.


 

 Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues

 

Category: Compliance-Regulation

This seminar will guide the attendee in effectively handling, addressing and remediating FDA's and other related compliance issues associated such as FDA's Form 483, Warning Letter and Consent Decree Compliance Findings.


 

 Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices

 

Category: Compliance-Regulation

Attendees will learn what, when, why, and how to conduct process validation in compliance with FDA and international agency regulations.


 

 Employment Laws Certificate Program for HR Professionals, Managers and Supervisors - 2 Days in person Seminar

 

Category: Compliance-Regulation

This training contains everything our Managers and Supervisors need to know to succeed and to protect our organizations by complying with Employment Laws by doing the right thing from a moral, ethical and legal way.


 

 Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices: 2-day In-person Seminar

 

Category: Compliance-Regulation

This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.


 

 Essentials for Personnel & HR Assistants

 

Category: HR MGMT

Whether you are new to HR or just wanting an update on current trends, this seminar immerses you in the important trends and changes facing HR professionals today!


 

 Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

The objective of this two day Essentials of USP Microbiology seminar is to explore USP General and General Information Chapters


 

 Estate Administration Boot Camp

 

Category: LAW - Elder Law / Estate Planning

Everything You Need to Know about Effectively Administering an Estate


 

 Estate Administration Procedures: Why Each Step Is Important

 

Category: LAW - Probate

Properly Administer Your Client's Estate


 

 Estate Planning and Administration: The Complete Guide

 

Category: LAW - Elder Law / Estate Planning

In this comprehensive legal guide, experienced attorney faculty will guide you through the process of estate planning and administration and show you how to select the best trust instruments and wield them skillfully to avoid mistakes at probate.


 

 Expense Reporting Best Practices: One and a Half Day In-Person Seminar

 

Category: Compliance-Regulation

This inter-active session will be filled with real-life examples and attendees will have the opportunity to not only interact with other attendees but see how they’d treat different delicate situations.


 

 Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2018/2019)

 

Category: Compliance-Regulation

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters.


 

 Exporting Marketing Channel Audits 2016

 

Category: MARKETING

This seminar focuses on the necessary procedures and documentations that are used by exporter and importers in this global economy.


 

 Facility, Maintenance and Calibration Considerations of the Quality Systems Inspection Technique (QSIT)

 

Category: Compliance-Regulation

Attend this seminar to learn the concepts for developing compliance programs to maintain the validated state. These programs are included in the Six-system Inspection Model of the Facility portion of the FDA Guidance For Industry – Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations.


 

 FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

 

Category: Compliance-Regulation

This training will examine the differences between Quality Assurance and Quality Control and the responsibilities of each. In addition, attendees will discuss what characteristics quality personnel should possess.


 

 FDA Import, Export and Foreign Operations for Medical Devices and Pharmaceuticals: 2-Day Workshop

 

Category: Compliance-Regulation

This workshop will cover the following topics in a live classroom setting:FDA Import Operations (including the role of US Customs)FDA Export Requirements and the Certification ProgramHow FDA handles foreign inspections


 

 FDA Penalties for Non-Compliance in Pharma - 2017 case studies and Readiness for 2018

 

Category: Compliance-Regulation

This hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance.


 

 FDA Recalls - Before You Start, and After You Finish

 

Category: Compliance-Regulation

The seminar will cover critical performance targets for conducting an effective recall. You will learn how missteps in the recall process become an expensive problem in terms of money and a sloppy corporate image.


 

 FDA Regulations for Dietary Supplements Manufacturers (21 CFR Part 111, GMP and QMS)

 

Category: Compliance-Regulation

This course will show the FDA’s requirements for dietary supplement manufacturing and teach how to implement the concepts in a plant and manage the compliance requirements using the quality management system approach.


 

 FDA Requirements for Food Defense Planning and Implementation

 

Category: Compliance-Regulation

The seminar also will involve a detailed discussion of an acceptable Food Safety Plan to be developed by the companies which are covered by the Rule.


 

 FDA Scrutiny of Promotion and Advertising Practices

 

Category: Compliance-Regulation

This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept


 

 FDA Scrutiny of Purchasing/Supplier Controls

 

Category: Compliance-Regulation

Regulatory requirements for medical device companies seem to constantly undergo review and change, with increased emphasis on specific aspects based on recall, error and warning letter trends.


 

 FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

 

Category: Compliance-Regulation

Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety.


 

 FDA's Import Program for 2016 - New Pathways and Pitfalls: 2-Day In-Person Seminar by Ex-FDA Official

 

Category: Compliance-Regulation

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier.


 

 FDA's Medical Device Software Regulation Strategy

 

Category: Compliance-Regulation

This seminar will help those involved in overcoming these commercial and regulatory obstacles. It will highlight the need for firms to remain current with technological tools and strategy to remain competitive, and ideally, outside FDA’s regulatory radar.


 

 FDA's New Import Program for 2019 - Strict Precision

 

Category: Compliance-Regulation

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier.


 

 FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy

 

Category: Compliance-Regulation

This 2 day course will show how to submit a traditional, abbreviated and special 510(k) for a Class II Medical Device. It will discuss what to look for in a predicate device and how to show substantial equivalence.


 

 FDA's Regulation of Implantable and Wearable Sensors: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

Sensors have begun to revolutionize human health due to their ability to provide real time health monitoring under a diverse set of conditions.


 

 FMLA and ADA Compliance Certificate Program: Everything You Ever Wanted to Know

 

Category: Compliance-Regulation

This is a thorough Certificate Program which will provide you with the tools and resources you need to maintain compliance with these two important laws and regulations and to serve as an internal consultant to minimize organizational risk.


 

 FMLA Compliance

 

Category: EMPLOYMENT LAW

Avoid costly mistakes from ever-changing FMLA legal requirements


 

 FMLA Compliance Update

 

Category: HR MGMT

Can you afford to make a mistake when it comes to FMLA?


 

 FMLA, ADA and PDA Certificate Program : 2-Day In-Person Seminar

 

Category: Compliance-Regulation

This is a thorough Certificate Program Training which will provide you with the tools and resources you need to maintain compliance with these three important laws and regulations and to serve as your organization internal consultant to minimize organizational risk.


 

 Food labelling and advertising requirements for foods sold in Australia and New Zealand

 

Category: Compliance-Regulation

n this two day workshop conference you will learn of the mandatory Australian and New Zealand requirements in labelling a compliant food


 

 Food Safety and Defense: Key Factors to Safely Manufacture, Package and Handle Food Products

 

Category: Compliance-Regulation

This course will focus on Food Safety and Defense: key factors to safely manufacture, package, and handle food products. It will cover a broad range of: production types, facilities, and the transportation of goods


 

 Fundamentals of EU MDR and IVDR – Level 1

 

Category: Compliance-Regulation

This 2 day seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Device Regulation (IVDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.


 

 Fundamentals of Trust Drafting and Estate Administration

 

Category: LAW - Elder Law / Estate Planning

Our intensive full-day primer will provide you with a comprehensive overview of trust drafting and estate administration processes.


 

 Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

 

Category: Compliance-Regulation

This one-day workshop covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation.


 

 Handling the Medical Malpractice Case in Rhode Island

 

Category: LAW - Medical

In this legal guide, our experienced attorney faculty will uncomplicate medical malpractice issues by equipping you with tips and strategies related to records and charts, sample motions, damage calculation, expert witness reports and Medicare set-asides.


 

 Handling the Medical Malpractice Case in South Carolina

 

Category: LAW - Medical

Hear perspectives from both sides of the table and zealously represent your clients


 

 HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer

 

Category: Compliance-Regulation

This seminar will also explain audits and enforcement, and how privacy regulations relate to security and breach regulations, as well as responding to privacy and security breaches and ways to prevent them.


 

 HIPAA Security and Breach Rule Compliance- Understanding Risk Analysis, Policies and Procedures and Managing Incidents

 

Category: Compliance-Regulation

This session will also explain HIPAA Security safeguards and the role of risk analysis in effectively evaluating and implementing Security Rule compliance. Audits and enforcement will be explained, as well as security breaches and how to prevent them.


 

 How to apply ISO 62304 standard in a medical software development project?

 

Category: Compliance-Regulation

This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation


 

 How to build and validate Excel spreadsheets for GxP compliance

 

Category: Compliance-Regulation

This two-day seminar teaches how to develop and validate Excel spreadsheets for 21 CFR Part 11 compliance. This training event covers all of the required features that have to be configured in Excel.


 

 How to Implement a Quality Management System According ISO 13485?

 

Category: Compliance-Regulation

Attend this seminar to learn medical device quality management standard ISO 13485. It will cover the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit is working.


 

 How to Pass the Customs Broker Exam

 

Category: Compliance-Regulation

This course will advise on the best investment of physical products (book rack, calculator, tabs, notes), teach the way Customs approaches the classification of products in their scenario based tests.


 

 How to prepare a 510(k) Notification and a Technical File for the CE Mark

 

Category: Compliance-Regulation

The first day of this 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products.


 

 How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings

 

Category: Compliance-Regulation

This two day seminar will provide valuable tips about the logistics, planning, conduct and best practices for all kinds of meetings with the FDA


 

 Human Error Reduction Program: How to investigate, predict, prevent, correct & recover from Human Error in the manufacturing floor and GMP environments

 

Category: Compliance-Regulation

This training will provide you with the steps required to help you implement a Human Error Reduction Program at your site. It includes practical tools, and how to measure effectiveness to continuously improve human reliability at your site.


 

 Human Factors and Predicate Combination Products

 

Category: Compliance-Regulation

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents.


 

 Human Resource Essentials - HR Compliance Certification Program

 

Category: Compliance-Regulation

I think I am not even half way with the list that HR Professionals are expected to do. Don’t you worry. You have found the right Certificate Program that will provide with all the tools necessary to be the best HR Professional one can be!


 

 Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety.


 

 Implementing UDI (Unique Device Identification) - Plan Now for Success

 

Category: Compliance-Regulation

The one-day workshop provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter.


 

 Integration of Human Factors into Medical Device Design: FDA and European Commission - 2-Day In-person Seminar

 

Category: Compliance-Regulation

The benefits of this course include the following:Show you how Human Factors can actually decrease development time and overall product development costs.Show how to plan and execute strategic Human Factors testing cycles.


 

 Interconnecting Cisco® Networking Devices Part 1 (ICND1)

 

Category: COMPUTERS / IT

This course focuses on providing the skills and knowledge necessary to install, operate, and troubleshoot a small branch office Enterprise network, including configuring a switch, a router, and connecting to a WAN and implementing network security.


 

 Interconnecting Cisco® Networking Devices Part 2 (ICND2)

 

Category: COMPUTERS / HW

This course focuses on skills and knowledge necessary to install, operate, and troubleshoot a small to medium-size branch office Enterprise network, including configuring several switches and routers, connecting to a WAN and implementing network security.


 

 Introduction to Antimicrobials in Veterinary Medicine

 

Category: Compliance-Regulation

This seminar will provide attendees with a basic understanding of Veterinary Antimicrobials in the context of veterinary drug development.


 

 Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings

 

Category: Compliance-Regulation

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.


 

 Is your Medical Device Software 510(k) Ready?

 

Category: Compliance-Regulation

This two day seminar will be jammed packed with numerous lessons learned, case studies, and specific directions that showcase what is required for a faster and successful 510(k) submission for your Medical Device Software.By implementing the ideology, tools and techniques that will be discussed in this two-day seminar will surely help Instill the Value of Safety within your workforce.


 

 Keeping Secrets beyond HIPAA: How to Maintain and Dispose of Patient Medical Records and Keep Client Confidentiality in Mental Health

 

Category: Compliance-Regulation

This seminar will first review the standardized HIPAA requirements for patient medical records. From that perspective, the seminar will answer the issues presented by expanding to review state laws on patient confidentiality, evidentiary privileges.


 

 Key Themes and Tactics in Medical Malpractice

 

Category: LAW - Medical

This engaging course offers a comprehensive overview of common substantive arguments that you're likely to encounter in medical malpractice cases.


 

 Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)

 

Category: Compliance-Regulation

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America


 

 Linux - System Administration

 

Category: COMPUTERS / IT

Students will gain hands-on experience with kernel customization, package management, process and disk management, as well as user and group management.


 

 Linux System Administration

 

Category: COMPUTERS / IT - Linux / Unix OS

This hands on Linux administration course teaches students how to install, configure and maintain a Linux system in a networked environment.


 

 Management Skills for Secretaries, Support Staff & Administrative Assistants

 

Category: ADMINISTRATIVE PROFESSIONALS - Advanced

Learn to make decisions with confidence, and manage people, projects, and time effectively


 

 Managing Regulatory Inspections Training - The Dos and Don'ts Before, During And After an FDA GCP Inspection

 

Category: Compliance-Regulation

Good Clinical Practice (GCP) inspection by the US Food and Drug Administration (FDA) can lead to the detection of problems with the conduct of your clinical trials. FDA requirements regarding GCP and related inspections have been around for decades. Despite this, GCP noncompliance is still a major reason for FDA rejection of clinical study data or other regulatory action.


 

 Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

 

Category: Compliance-Regulation

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.


 

 Managing Your FDA Inspection: Before, During and After

 

Category: Compliance-Regulation

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection.


 

 Maximizing Medical Malpractice Damages

 

Category: LAW - Medical

In this program, seasoned faculty will provide you with best practices and hard-won strategies that produce results at the negotiating table and in the courtroom.


 

 Medicaid: Beyond the Basics

 

Category: LAW - Health Care

This authoritative session will provide you with much needed answers to the complex questions on Medicaid eligibility, asset transfers and preservation and how to adapt your practice to change. Let our distinguished faculty be your guides through the maze of government regulations and financial strategies and lead you to the highest level of mastery.


 

 Medical and Dental Practice OSHA Compliance Course

 

Category: HEALTH CARE

This one-day comprehensive training is the perfect solution to help you keep your practice safe and 100% OSHA compliant!


 

 Medical Device Architecture - Design for Safety: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

This two day interactive course will also address the basic risk management methods and risk related methodologies like FMECA that significantly influence the architectural design.


 

 Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency

 

Category: Compliance-Regulation

The medical device risk management (ISO 14971) course will be given using an interactive workshop format taking attendees through all of the risk management activities required by ISO 14971.


 

 Medical Device Single Audit Program (MDSAP) - How to implement MDSAP in an existing Quality Management System (QMS)?

 

Category: Compliance-Regulation

This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.


 

 Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

 

Category: Compliance-Regulation

This two-day seminar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect when signing onto the program.


 

 Medical Experts and Records

 

Category: LAW - Health Care

In this focused legal program, seasoned medical experts and veteran civil litigators will provide both plaintiff and defense expert witness strategies.


 

 Medical Malpractice From A-Z

 

Category: LAW - Medical

At this one-day seminar, our faculty will provide a thorough understanding of, and guide you through, a common medical malpractice case from start to finish.


 

 Medical Records Management and Legal Compliance

 

Category: HEALTH CARE

Handle critical healthcare records confidentially, efficiently, and accurately while maintaining legal compliance.


 

 Medicare Secondary Payer, Medicare Set-Asides and Mandatory Insurance Reporting in Personal Injury Litigation

 

Category: LAW - Health Care

This engaging legal course includes in-depth discussions on mandatory insurer reporting, Medicare conditional payments, and Medicare Set-Asides. Get practical guidance in resolution of Medicaid liens and the creation and administration of special needs trusts.


 

 Microsoft Exchange Server

 

Category: COMPUTERS / IT - Systems Management

Invest just 2 days, and learn to install, troubleshoot, and manage all aspects of Exchange Server


 

 Microsoft SQL Server 2012 Administration

 

Category: COMPUTERS / IT - Database

This 5-day class consists of five days of hands-on training that focus on the fundamentals of administering the SQL Server 2012 database engine. Participants in this course will come away with the knowledge and experience required to administer SQL Server 2012.


 

 Microsoft SQL Server 2014 Administration

 

Category: COMPUTERS / IT - Database

This class consists of five days of hands-on training that focus on the fundamentals of administering the SQL Server 2014 database engine.


 

 Modern HIPAA Compliance - Managing Privacy, Security, and Breach Notification in a World of New Technologies, New Threats, and New Rules

 

Category: Compliance-Regulation

The HIPAA Regulations carry significant obligations to protect the privacy and security of Protected Health Information, and significant penalties in the millions of dollars can result from non-compliance.


 

 Mortgage Lending Today: Litigation and Regulatory Guide

 

Category: LAW - Real Estate

This is a must-attend seminar for any attorney, lender or servicer who is looking to remain up to date on the latest developments.


 

 Navigating Federal Wage and Hour Compliance Issues under the Fair Labor Standards Act

 

Category: Compliance-Regulation

Periodically, the Wage and Hour Division (WHD) of the Department of Labor (DOL) issues updates and new regulations that employers must comply with or face stiff penalties.


 

 Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits

 

Category: Compliance-Regulation

Medical Device Reporting (MDR), and Recall compliance are critical to the continue survival of all device manufacturers.


 

 Navigating the Medical Malpractice Case

 

Category: LAW - Medical

This basic-to-intermediate level program will walk you through a medical malpractice case, from initial evaluation and assessment through the trial phase.


 

 Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada

 

Category: Compliance-Regulation

In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.


 

 OSHA Compliance

 

Category: SECURITY/SAFETY

Keep your workplace safe and stay fully compliant with OSHA's ever-changing regulations


 

 Overview of clinical drug development from final preclinical selection, marketing approval, all phases of clinical trials, new strategies, challenges and solutions: 2-day In-person Seminar

 

Category: Compliance-Regulation

Participants will be introduced to major clinical steps and considerations in the new drug development process. Starting with the selection of medically promising molecules, through the execution of major I-IV phases of clinical trials.


 

 Pharmaceutical Supply Chain Integrity - Good Distribution Practices (GDP)

 

Category: Compliance-Regulation

This course puts these into a logical perspective so that the participant can identify the correct GDP requirements unique to their company's operations, including those for material management, manufacturing control and packaging control.


 

 Practical Guide to Zoning and Act 250

 

Category: LAW

Join us at this seminar where you'll learn to facilitate positive outcomes by understanding key components of the approval process, procedures for challenging a zoning decision, as well as requirements for administrative approach.


 

 Preparing for FDA's New Import/Export Trauma in 2020

 

Category: Compliance-Regulation

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment.


 

 Principles and Application of Hazard Analysis Critical Control Point (HACCP)

 

Category: Compliance-Regulation

The training is presented over 2 days which cover the 5 preliminary steps and the 7 principles of HACCP. Practical examples and activities are provided to assist with development and implementation within your food business.


 

 Process Validation for Medical Devices: 2-day In-person Seminar

 

Category: MANUFACTURING/OPERATIONS - QC/QA

This course will help attendees understand the regulatory requirements and the statistical methods needed to perform effective process validation for medical device manufacturing.


 

 Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

 

Category: Compliance-Regulation

This two day, interactive Seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.


 

 Project management tools to improve productivity and compliance in Analytical laboratories: 2-day Workshop

 

Category: PROJECT MANAGEMENT

In this two day workshop you will learn the different tools of PM, proper mind set/expectations and sound lean lab management program skills in order to develop and implement efficient techniques.


 

 Quality and GMP Compliance for Virtual Companies - Pharmaceutical and Biologics Industries

 

Category: EDUCATION/TRAINING

In this two day workshop conference you will learn the requirements and expectations of major health care regulators


 

 Quality by Design: A New Paradigm for the Development and Commercialization of Biopharmaceuticals

 

Category: Compliance-Regulation

This seminar will provide the attendee with an understanding of how the Quality by Design approach has altered the way in which modern biopharmaceuticals are developed, manufactured, and licensed by the regulatory authorities.


 

 Quality Control Laboratory Compliance - cGMPs and GLPs

 

Category: Compliance-Regulation

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions


 

 Radiation Sterilization of Medical Products - Beyond the Basics

 

Category: Compliance-Regulation

This workshop has been designed to help attendees learn the ins and outs of all the radiation modalities, materials selection, and validation of the sterilization process per ISO 11137.


 

 REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

 

Category: Compliance-Regulation

REACH and RoHS have been referred to as …one of the most complex regulations in the history of the EU. Do not miss this 2 day seminar to find out why


 

 Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

 

Category: Compliance-Regulation

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.


 

 Registration & Listing, FDA Inspection Strategies and Compliance Initiatives - Medical Device. - By Compliance Global Inc.

 

Category: Compliance-Regulation

webinar on FDA Inspection Strategies and how they reach decisions in developing inspection and compliance plans. Registration and how FDA uses this data will be discussed


 

 Regulatory Compliance for Dietary Supplements in the US, EU and Canada - 2-Day In-Person Seminar

 

Category: Compliance-Regulation

A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States, EU and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in these countries.


 

 Regulatory Requirements and Principles for Cleaning Validation: 2-Day In-person Seminar

 

Category: Compliance-Regulation

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning.


 

 Representing Your Client in Federal Court

 

Category: LAW - Federal Litigation

Acquire a competitive edge with a thorough understanding of recent electronic changes that affect the federal court system.


 

 Risk Management in Medical Devices Industry

 

Category: Compliance-Regulation

By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.


 

 Roadmap of California Medical Leaves - Ultimate Guide to PDL, FMLA, FEHA, SDI, CFRA, PFL, ADA and Workers Compensation and Handling Performance Management Challenges

 

Category: Compliance-Regulation

The seminar will focus on how California leaves such as FEHA and CFRA interact with Federal medical leaves, such as the FMLA and ADA.


 

 Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

 

Category: Compliance-Regulation


 

 Seminar on 21 CFR Part 11 compliance for software validation and SaaS/Cloud

 

Category: Compliance-Regulation

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.


 

 Seminar on Applied Statistics for FDA Process Validation

 

Category: Compliance-Regulation

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance.


 

 Seminar on Applying ISO14971 and IEC62304 - A guide to practical Risk Management

 

Category: Compliance-Regulation

This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.


 

 Seminar on Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)

 

Category: MEDICINE/NURSING

This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries.


 

 Seminar on Audit Like the FDA - What you need to know for a truly effective internal audit program

 

Category: Compliance-Regulation

This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance.


 

 Seminar on Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices

 

Category: Compliance-Regulation

This seminar begins with outlining the structural role of the FDA and a brief introduction to the Food, Drug and Cosmetic Act and how the FDA uses it to enforce the regulatory requirements during the drug, biologics and medical device approval process.


 

 Seminar on Combination Products

 

Category: MEDICINE/NURSING

Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.


 

 Seminar on Combination Products Regulations: Drug and Device Combinations in the USA and EU

 

Category: Compliance-Regulation


 

 Seminar on Complaint Handling and Management: From Receipt to Trending

 

Category: Compliance-Regulation

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.


 

 Seminar on Complaint-Handling, MDR and Recall Management

 

Category: Compliance-Regulation

Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system. Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls


 

 Seminar on Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach

 

Category: MANUFACTURING/OPERATIONS - QC/QA

This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.


 

 Seminar on Complete 1099, TIN Matching, B-Notice, FATCA and Non-resident Alien 1042-S Compliance Update

 

Category: FINANCE/INVESTING - International Finance & Taxation


 

 Seminar on Construction: OSHA Construction Hazards for any Jobsite

 

Category: LAW - Construction

How to train staff to have the correct documentation in place. Ensure that the organization keeps documentation updated and realistic.


 

 Seminar on Data Integrity - Beyond 21 CFR 11 & Annex 11

 

Category: Compliance-Regulation

This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.


 

 Seminar on Design of Experiments and Statistical Process Control for Process Development and Validation

 

Category: Compliance-Regulation

This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes.


 

 Seminar on Drug dissolution testing and establishing plasma drug levels in humans

 

Category: LAW - Health Care


 

 Seminar on Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices

 

Category: MEDICINE/NURSING

This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements .


 

 Seminar on Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry

 

Category: Compliance-Regulation

This seminar will provide an overview and in-depth snapshot and a refresh of internal and external auditing. Those interested in how to prepare for a QA audit and how to enhance their internal/external quality audit system as a valuable regulatory compliance tool will also benefit from this course.


 

 Seminar on FDA Concepts for Medical Device Companies - Regulations, Myths, Challenges, and Best Practices

 

Category: MEDICINE/NURSING

This seminar will show you how to structure and optimize your QMS. It all starts with Management Responsibility and a commitment to quality. We'll discuss the concepts of management responsibility, a culture of quality, and continuous improvement.


 

 Seminar on FDA Device Software Regulation

 

Category: LAW - Environmental Law

Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles.


 

 Seminar on FDA Legal Writing Skills that Result in Effective Regulatory & Quality Submissions

 

Category: Compliance-Regulation

In this seminar, you will learn the legal writing skills and practical techniques that will enhance your chances for success even if some of your test results or other supporting information are somewhat lacking. Remember, good regulatory writing will meet FDA branch-level requirements but the best and most effective submissions can withstand scrutiny at the FDA Division level.


 

 Seminar on FDA Scrutiny of Promotion and Advertising Practices

 

Category: Compliance-Regulation


 

 Seminar on FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

 

Category: Compliance-Regulation

To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements.


 

 Seminar on Food Safety and Defense: Key Factors to Safely Manufacture, Package and Handle Food Products

 

Category: FOOD INDUSTRY

This Seminar will focus on Food Defense & will detail what an organization needs to have in place in order to safely manufacture, package, & or handle food products. It will cover a broad range of: production types, facilities, & transportation of goods.


 

 Seminar on Global Medical Device Regulations

 

Category: Compliance-Regulation

overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements.


 

 Seminar on Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements

 

Category: Compliance-Regulation


 

 Seminar on HIPAA - Putting an Organizational Compliance Program in Place

 

Category: HEALTH CARE

This starts with the fundamentals of a HIPAA compliance program.If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course.


 

 Seminar on HIPAA Compliance for Small Healthcare Providers

 

Category: HEALTH CARE

If your small healthcare practice needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive Two-day training course.


 

 Seminar on How FDA Trains Its Investigators to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection

 

Category: Compliance-Regulation

The Seminar will provide all details relevant to Pre and Post-Inspectional activities, tactics, strategies and is a must for those who have never gone through an FDA inspection


 

 Seminar on How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process

 

Category: Compliance-Regulation

This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the


 

 Seminar on Human Factors and Predicate Combination Products

 

Category: Compliance-Regulation

This seminar will compare these Guidance documents. Additionally, strategic recommendations will be presented on how to implement these requirements into the medical device design, development and approval processes. Finally, Human Factors methods and best practices will be covered that the FDA is requiring.


 

 Seminar on Human Subjects Research Seminar: Current Regulations under FDA and HIPAA

 

Category: Compliance-Regulation

This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA.


 

 Seminar on Implementing ISO 13485:2016

 

Category: Compliance-Regulation

This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them.


 

 Seminar on Internal Auditing for the Medical Device Industry

 

Category: MEDICINE/NURSING

This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement.


 

 Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices - Singapore

 

Category: Compliance-Regulation


 

 Seminar on Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines

 

Category: LAW - Medical

In this two day workshop seminar one will learn the different regulatory agencies expectations of the quantification and development of a sound statistical monitoring of process control that are utilized, effective, and efficient.


 

 Seminar on Marketing Products Without Getting Hammered by FDA

 

Category: Compliance-Regulation

Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion.


 

 Seminar on Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Water Systems for Bio/Pharma, Medical Devices, and Cosmetics Industries

 

Category: EDUCATION/TRAINING

This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.


 

 Seminar on Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)

 

Category: MEDICINE/NURSING


 

 Seminar on Medical Device Software: An Incremental Approach to Risk and Quality Management

 

Category: MEDICINE/NURSING


 

 Seminar on on Why is FDA at my Facility, and what do I do During an Inspection

 

Category: Compliance-Regulation

This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.


 

 Seminar on Overview of Device Regulation - FDA

 

Category: Compliance-Regulation

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices


 

 Seminar on Payroll Fundamentals

 

Category: ACCOUNTING - Payroll

This 2 day will give the participant the tools to be a well-rounded payroll professional or the understanding of the complexities of payroll for professionals that support the payroll function.


 

 Seminar on Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA

 

Category: Compliance-Regulation

This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies.


 

 Seminar on Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls

 

Category: FOOD INDUSTRY

This training session will present a practical approach to provide you and your team members with needed understanding and tools and a basic strategy for designing, implementing and validating preventive process controls.


 

 Seminar on QC Laboratory Compliance and Meeting FDA Requirements

 

Category: Compliance-Regulation

This two-day course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical and medical device Quality Control laboratories.


 

 Seminar on Quality by Design - Essential Techniques for Medical Devices

 

Category: MEDICINE/NURSING

In this seminar, we will cover Design Controls for medical devices. We will understand the requirements for design controls and how to translate them into an efficient and effective process for your company.


 

 Seminar on Requirements for Supplier Management 2016 for Medical Device Manufacturers

 

Category: LAW - Medical

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding.


 

 Seminar on Risk Management in Medical Devices Industry

 

Category: LAW - Medical

This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.


 

 Seminar on Statistics for the Non-Statistician

 

Category: Compliance-Regulation

During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data sets! The program begins by providing a basic overview of the most common statistical tools and terms.


 

 Seminar on Supplier Management for Medical Device Manufacturers

 

Category: MEDICINE/NURSING

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.


 

 Seminar on Texting and E-mail with Patients: Patient Requests and Complying with HIPAA

 

Category: HEALTH CARE

The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent understanding of not only the rules, but also how to think about compliance and make sound compliance decisions on a day-to-day basis in the context of mobile devices.


 

 Seminar on The A to Z's of HIPAA Compliance

 

Category: HEALTH CARE

This two day seminar takes the participants through HIPAA compliance from start to compliance. The presentations explain the history of HIPAA, why it came to being and its evolution.


 

 Seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosmetics Industries

 

Category: Compliance-Regulation

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training


 

 Seminar on The A to Z's of Writing and Enforcing Effective SOPs

 

Category: Compliance-Regulation

This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from warning letters and then review the good and bad SOPs and templates. Standard operating procedures work best when they are designed to achieve specific results.


 

 Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future

 

Category: Compliance-Regulation

This workshop will provide valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files / Design Dossiers, documents, activities / plan(s).


 

 Seminar on Tools and Techniques for Operational Risk Management: Regulatory Aspects

 

Category: FINANCE/INVESTING - Risk Management

In this seminar, we go through the known techniques of operational risk management, including of course the regulatory aspects, and point to a few shortcomings that appeared in several (possibly nameless) banks.


 

 Seminar on Tougher Import Rules for FDA Imports in 2016

 

Category: Compliance-Regulation

The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities.


 

 Seminar on Validating Radiation Sterilization for Medical Products

 

Category: MEDICINE/NURSING

Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.


 

 Seminar on Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

 

Category: Compliance-Regulation

This 2-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements.


 

 Seminar on Verification vs. Validation - Product Process Software and QMS

 

Category: MEDICINE/NURSING

This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance.


 

 Seminar on What to Expect in a Federal HIPAA Audit & How to Avoid Audit

 

Category: HEALTH CARE

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017.


 

 SharePoint 2010 Customization and Administration

 

Category: COMPUTERS / IT

This 5-day hands on course teaches students how to develop and deploy SharePoint 2010 sites and also teaches students how to implement security, connect to databases, and administer and monitor SharePoint sites.


 

 SharePoint 2013 Customization and Administration

 

Category: COMPUTERS / IT

This hands-on course teaches students how to deploy, configure, manage and customize the SharePoint 2013 environment. The course begins with a thorough overview of


 

 SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

 

Category: Compliance-Regulation

This two day In-person seminar will provide step by step instructions to create SOPs for FDA-regulated organizations.


 

 State vs. Federal Rules of Procedure and Evidence

 

Category: LAW

Let our team of experienced litigators guide you in a comparative analysis of state and federal civil procedure and offer practical tips for applying the rules to ensure your cases' smooth travel through the court corridors.


 

 Statistical Process and Quality Control

 

Category: Compliance-Regulation

This 2-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts and acceptance sampling systems and procedures.


 

 Statistical Techniques for Medical Device Manufacturers: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to


 

 Statistics for Quality Engineering

 

Category: Compliance-Regulation

The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations?


 

 Supplier and Contractor Qualification and Control for Life Science Industry

 

Category: Compliance-Regulation

This two-day course focuses on the processes associated with the acquisition of products, materials and services that fuel and support the organization’s product manufacturing and marketing.


 

 Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar

 

Category: Compliance-Regulation

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.


 

 Supplier Quality Agreements - Essential for suppliers of most outsourced processes

 

Category: Compliance-Regulation

This presentation will provide an understanding of what the current guidance documents suggest you include in supplier agreements.


 

 Systematic Operating Procedures (SOPs) – What’s Really Required

 

Category: Compliance-Regulation

Learn the required components and elements of SOPs for FDA regulated industries and meet the FDA compliance and SOP expectations.


 

 The Administrative Assistants Conference

 

Category: ADMINISTRATIVE PROFESSIONALS - Fundamentals

Become an indispensable star assistant!


 

 The Complete Payroll Law Seminar - Red flags, Most Recent Case Studies affecting Payroll, Overtime Pay, Comp Time, the FMLA, the ACA and Many More

 

Category: Compliance-Regulation

This seminar will help you to streamline your payroll processing procedures. You will learn how to compute worker's pay considering overtime pay, comp time, and regulations like the FMLA, the FSLA, the Fair Labor Standards Act, the ACA.


 

 The Conference for Administrative Assistants

 

Category: ADMINISTRATIVE PROFESSIONALS - Fundamentals

Hundreds of practical ideas, solutions, and strategies for reaching your peak success level.


 

 The Development and Implementation of a Robust Food Safety, Defense and Quality Assurance System

 

Category: Compliance-Regulation

In this two-day workshop, you will learn strategies for matching the reality to the theory of product safety, security, defense and quality assurance together.


 

 The Essentials of OSHA Compliance

 

Category: SECURITY/SAFETY

A comprehensive 2-day update in workplace safety issues and the latest OSHA regulations


 

 The Human Resources Conference

 

Category: HR MGMT

Essential skills, fresh ideas and cutting-edge information on the latest rules and regulations of employment laws


 

 The Indispensable Assistant

 

Category: ADMINISTRATIVE PROFESSIONALS - Fundamentals

Achieve the results you want and win the respect you deserve


 

 The Life Cycle Approach to Cleaning Validation

 

Category: Compliance-Regulation

The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy


 

 The New OSHA Recordkeeping Rule & Surviving An OSHA Audit: In-Person Seminar

 

Category: Compliance-Regulation

The U.S. Occupational Safety and Health Administration (OSHA) has changed elements of the 29 Code of Federal Regulation (CFR) 1904 to include electronically submittal of injury and illness data.


 

 The Outstanding Receptionist (afternoon)

 

Category: ADMINISTRATIVE PROFESSIONALS

Learn ways to perfect your telephone skills, provide exceptional customer service and present a positive first impression


 

 The Outstanding Receptionist (morning)

 

Category: ADMINISTRATIVE PROFESSIONALS

Learn ways to perfect your telephone skills, provide exceptional customer service and present a positive first impression


 

 The Paralegals Guide to Deciphering Medical Records

 

Category: LAW - Medical

Join us at this informative seminar to get the knowledge you need to effectively use medical information to support your client's case theory.


 

 The Regulations of OTC Drugs

 

Category: Compliance-Regulation

This course on FDA regulation of OTC drug products is intended to provide attendees with the knowledge and skills needed to develop and produce an OTC Drug Product for marketing and sale in the U.S.


 

 The Ultimate Course in Payroll Management

 

Category: ACCOUNTING - Payroll

The first step to complying with regulations is understanding them. That's why you'll begin your day with a crash course in payroll's legal basics. You'll find out what areas fall under state, federal, and joint regulation, and learn how to avoid the often staggering penalties and fines of non-compliance.


 

 The Veterinary Drug Approval Process and FDA Regulatory Oversight

 

Category: Compliance-Regulation

This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA’s veterinary drug approval process


 

 The Workshop for Personnel/HR Assistants

 

Category: HR MGMT

Powerful training for personnel and HR staff


 

 Trust Administration: Preventing and Litigating Fiduciary Liability

 

Category: LAW

Get both the proverbial “ounce of prevention” and the “pound of cure” in one day of incisive study. This course uses a perfect blend of legal and financial expertise to provide a balanced guide to trust administration and fiduciary liability litigation.


 

 Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies

 

Category: Compliance-Regulation

In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development.


 

 US GCP Fundamentals for Pharmaceutical and Biologic Companies

 

Category: Compliance-Regulation

This seminar provides an introduction to GCP, with emphasis on the regulations governing drug and biologic clinical trials. (Most of the information is also applicable to medical devices, but specific requirements for device trials are not discussed.)


 

 US Good Clinical Practice (GCP) Regulations and ICH GCP Guidelines

 

Category: Compliance-Regulation

This program will emphasize FDA's GCP requirements for human use pharmaceutical and biologic drug products.


 

 Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

 

Category: Compliance-Regulation

This 2-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements.


 

 Vendor and Supplier Qualification Program for FDA Regulated Industries

 

Category: Compliance-Regulation

This workshop explains an overarching supplier qualification program that is common to FDA regulated medical product manufacturers. It also provides the details of the various program areas such as devices, pharmaceuticals, etc.


 

 Wage and Hour Law

 

Category: EMPLOYMENT LAW

Handle FLSA Claims with Confidence


 

 WebSphere Application Server v5.x Administration

 

Category: COMPUTERS / IT - Network Administration

This seminar will focus on the administration of a WebSphere v5.x Application Server implementation.


 

 Why is FDA at my facility, and what do I do during an inspection?

 

Category: Compliance-Regulation

This course begins with a high level discussion about why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements.


 

 Windows 2008 System Administration

 

Category: COMPUTERS / IT

This course provides hands on experience installing and configuring Windows Server 2008. Students will perform full and core CD-based standard installation, deploy an image, configure and tune the server and assign roles and services.


 

 Windows 2012 System Administration

 

Category: COMPUTERS / IT - Database

This course provides hands on experience installing and configuring Windows Server 2012. Comprehensive labs and exercises give the students real experience deploying, managing and troubleshooting the Windows 2012 infrastructure.


 
 

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