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 Advanced Strategies for Controllers Onsite Training

 

Category: ACCOUNTING

Particularly useful in today’s economic uncertainty, this seminar will help you manage information for increased profits!


 

 21 CFR Part 11/Annex 11 compliance for software validation and SaaS: In-person Seminar

 

Category: Compliance-Regulation

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


 

 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.


 

 Accounts Payable 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.


 

 Achieve Better Results with Simplified Strategic Planning for Small to Mid-Sized Companies

 

Category: PLANNING - Strategic planning

A Two-Day, Interactive, Limited Enrollment Seminar for CEOs, Company Presidents and Other Top Executives of Independent Companies and Subsidiaries of Larger Companies


 

 Advanced Coaching Certificate featuring the Coaching Skills Lab

 

Category: GENERAL MGMT - Coaching/Mentoring/Counseling

Improve your credibility as a coach, benefit from a deeper understanding of the strategies necessary to catalyze strategic behavioral change in leaders, and increase your confidence in your ability to coach every level of the organization, including senior leaders.


 

 Advanced Internal Investigations Certificate Program

 

Category: HR MGMT

Learn best practices for handling FMLA and disability fraud and post-investigation issues and more!


 

 Advanced Microsoft® Excel® - Macros, PivotTables, Charts and More

 

Category: COMPUTERS / SW - Office Software

Understand and unleash the power of Excel’s most complex capabilities


 

 Aerospace Program Management - It's More than Scheduling and Delivery

 

Category: Compliance-Regulation

Effective and efficient management of today's complex and integrated programs requires both the refinement of interpersonal and basic leadership skills as well as the application of appropriate technologies and tools.


 

 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.


 

 Analytical Methods in Development and Manufacture of Drugs and Biologics

 

Category: Compliance-Regulation

This course starts with discussing the new paradigm of quality, QbD, and role of analytical methods in ensuring quality.


 

 Applications of Statistics to Pharmaceutical Operations with Explanatory Statistics and Sampling Software

 

Category: Compliance-Regulation

Understand the statistics methodologies associated with risk-based qualification of instruments and equipment, and validation of test methods and manufacturing processes.


 

 Applied Practical Statistics, with Emphases on Verification, Validation, Sample Size, and Risk Management in R&D, Mfg. and QA/QC

 

Category: Compliance-Regulation

Almost all design and/or manufacturing companies evaluate product and processes in order to either manage risks, validate processes, establish product/process specifications, QC to such specifications, and/or monitor compliance to such specifications. The various statistical methods used to support such activities can be intimidating.


 

 Basic Business Management: Boot Camp for Business Owners

 

Category: BUSINESS

Owning a business requires a vision balanced with attention to detail. You need to be a generalist who understands the multiple aspects of running a business, as well as the ability to step back and see the big picture and to reach into the future.The business environment is a complex place to be. Whether you wish to work as a consultant or freelancer, establish a corporation, or set up an operation that meets a need for very particular type of customer, there is a tremendous amount of information that you need to know and to apply.This three-day course provides essential learning for new business owners, whether the business is just in the idea stage or you have already begun and need to fill in the gaps.


 

 Biopharmaceutical Test Method, Methods from Cradle to Grave - Technical, Regulatory & Business Considerations

 

Category: Compliance-Regulation

In this two day workshop conference you'll learn about how analytical methods impact various activities, best practices, and needs versus nice to have items.


 

 BOOT CAMP: Foreclosure and Loan Workout Procedures

 

Category: LAW - Foreclosure

Expert faculty will identify all of the options available for loan defaults and guide you through their mechanics


 

 Building a Fair and Equitable Pay Program – 3-Day In-person Seminar

 

Category: Compliance-Regulation

Pay management is said to be a mystery – at least, that’s what many traditionalists who work in pay management would have you believe. Certainly we are entitled to some job protection.


 

 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


 

 Business Continuity Auditing Plans Using ISO 22301

 

Category: Compliance-Regulation

The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO.


 

 Child Custody and Support Procedures: Form by Form

 

Category: LAW - Foreclosure

Get all the custody and support forms you'll need and find out when and how to use them.


 

 Civil Procedure and Judicial Review Outside of Trial

 

Category: LAW

This practical legal course will walk you through key court procedures you must navigate to ensure successful resolution of your clients' cases. Hear seasoned attorneys share their tips and experiences and improve your litigation skills.


 

 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.


 

 Coaching for Business Leaders

 

Category: GENERAL MGMT - Coaching/Mentoring/Counseling

Leaders, directors, and managers who want to drive results through targeted coaching choose the new Coaching Certificate for Business Leaders. As a participant, build trusting partnerships and maximize the growth potential of your direct reports. Apply strategies and tools to accelerate the development of your staff while pursuing organizational goals. Foster change, empower others, drive results and champion learning through coaching.


 

 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.


 

 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.


 

 Creating Highly Effective Social Media Procedures for HR

 

Category: HR MGMT

Learn solutions and real-world strategies to help you take control of social media and make it work successfully for your organization


 

 Current Foreclosure Alternatives

 

Category: LAW - Foreclosure

This seminar will review the process of choosing the best option for clients, pros and cons of each option, tax considerations of foreclosure avoidance techniques and procedures, and a brief discussion of future trends and expectations in the mortgage industry.


 

 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.


 

 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.


 

 Develop and Implement Restorative Programs

 

Category: HEALTH CARE

Gain critical information necessary to establish a restorative nursing program


 

 Developing Documents and Records to meet the Requirement of ISO 17025

 

Category: Compliance-Regulation

Develop and implement a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.


 

 Developing Your Training Program

 

Category: BUSINESS

Training is an essential element of development in any organization. Being knowledgeable and continuing to learn throughout your career can make you a very valuable asset. We also know that training and orientation (or ‘onboarding’) for newly hired employees is a key factor in retention.This two-day workshop is designed for a trainer who wants to develop training programs that are meaningful, practical, and will benefit both trainees and the organizations they work for.


 

 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.


 

 Drafting Effective Estate Plans

 

Category: LAW - Elder Law / Estate Planning

Attend this basic-level seminar to gain insight into the fundamentals of preparing estate planning documents, including wills, trusts, and ancillary documents.


 

 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.


 

 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.


 

 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


 

 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.


 

 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 Compliance and Clinical Trial Computer System Validation: 2-Day In-person Seminar

 

Category: Compliance-Regulation

The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as


 

 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.


 

 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.


 

 Foreclosure and Loan Workout Procedures

 

Category: LAW - Foreclosure

This course is designed to provide a procedural orientation to the foreclosure process and alternatives to foreclosure.


 

 Fostering Employee Engagement

 

Category: Compliance-Regulation

Would your organization like to boost employee engagement levels? Create and sustain a culture of engagement? Attract and retain the best people? If so, then this seminar is for you!


 

 Fundamentals of Successful Project Management

 

Category: PROJECT MANAGEMENT

Keep your projects on task, on time and on budget!


 

 HIPAA - The Requirements for a Compliance Program

 

Category: Compliance-Regulation

Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk.


 

 Hot Topics in Education Law

 

Category: LAW

Employ failsafe measures for correct and complaint student discipline and adhere to the laws governing 504 plans.


 

 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 Conduct a Workplace Harassment, Bullying & Violence Investigations Training

 

Category: Compliance-Regulation

The courts have opined that organizations must prevent and intervene on harassment complaints. The employer is required to demonstrate what it has done to prevent harassment.


 

 How to Write Effective Policies and Procedures

 

Category: COMMUNICATIONS - Publications/Manuals

In just one day, you´ll gain hundreds of rules, strategies, guidelines and shortcuts that will make your job easier and ensure you get the results you want—well-written policies and procedures that are read and understood by all.


 

 How to Write Error Free Procedures and Instructions: 2-Day In-Person Seminar

 

Category: Compliance-Regulation

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage.


 

 HR Policies & Procedures: How to Update, Communicate and Enforce

 

Category: HR MGMT

Gain proven-effective skills you can use to eliminate confusion and ensure understanding at all levels of your organization.


 

 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!


 

 IEP and 504 Plan Legal Workshop

 

Category: LAW

Take away valuable information you can use to spot potential issues in your school's IEP and 504 plan process.


 

 IEPs and 504 Plans: A Legal Compliance Guide

 

Category: LAW - School Law

Join our experienced faculty for this comprehensive workshop on mitigating legal liabilities in IEPs and 504 plans.


 

 Implementing a Successful Mentoring Program

 

Category: HR MGMT

This course will help you understand how to identify what's needed and to successfully design, implement and adjust a mentoring program.


 

 Import/Export Procedures and Documentation OnSite Training

 

Category: MANUFACTURING/OPERATIONS - Supply Chain

In this semianr you will Learn how to deal successfully with banks, freight forwarders, customs brokers and foreign customers. And find out how to use the necessary documents to obtain the greatest cost benefit for your company and timely execution of your orders!


 

 Internal Audit, Fraud Risk Assessment and Risk Management Annual Plan

 

Category: Compliance-Regulation

This seminar will equip you with a methodology that has been utilized in a robust internal audit department for a Billion dollar revenue Corporation


 

 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.


 

 Job Search Skills

 

Category: PERSONAL DEVELOPMENT

Searching for a job or climbing the career ladder can be intimidating. How do you determine your best career track, build a winning resume and cover letter, develop networking resources and find job leads, master the interview and most importantly, find help when you need it? Learn the answers to all these questions and more, plus a plan to get you on the right career track to a new job. You’ll be more than ready to start you search for your perfect job.


 

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

 

Category: Compliance-Regulation

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 accepted, effective, and efficient.


 

 Learn to Write Effective Policies & Procedures

 

Category: COMMUNICATIONS - Writing Skills

Save yourself countless hours of writing and rewriting and protect your company from the threat of legal liability


 

 Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency

 

Category: Compliance-Regulation

This highly interactive course consists of a lively mix of presentations, group exercises and discussions to provide an in-depth understanding of Quality Risk Management and know-how to be able to implement Quality Risk Management in the work place.


 

 Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer

 

Category: Compliance-Regulation

This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts.


 

 Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

 

Category: Compliance-Regulation

Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products.


 

 Maintenance Welding Principles and Procedures

 

Category: INDUSTRIAL TRAINING

Master the Complete Range of Welding Practices and Procedures—Increase Your Proficiency...Broaden Your Capabilities!


 

 Managing Multiple Projects, Objectives and Deadlines

 

Category: PROJECT MANAGEMENT

Get and keep control of competing priorities and critical deadlines


 

 Master Project Manager MPM®

 

Category: PROJECT MANAGEMENT

This course has been designed to include presentation, practical exercises and highly interactive group sessions.


 

 Mastering EXCEL Dashboard Reports

 

Category: GENERAL MGMT

Mastering EXCEL Dashboard Reports


 

 Mastering EXCEL Database Management Tools

 

Category: GENERAL MGMT

Mastering EXCEL Database Management Tools


 

 Mastering EXCEL Formulas and Functions

 

Category: GENERAL MGMT

Mastering EXCEL Formulas and Functions


 

 Mastering EXCEL Macros

 

Category: GENERAL MGMT

Mastering EXCEL Macros


 

 Mastering EXCEL Pivot Tables: How to Crunch Numbers Like an Expert

 

Category: GENERAL MGMT

Mastering EXCEL Pivot Tables: How to Crunch Numbers Like an Expert


 

 Mastering Microsoft Excel

 

Category: COMPUTERS / SW - Office Software

An effective 2-day seminar for beginners to advanced users. Packed with shortcuts, tips, and straight answers to all of your Excel questions.


 

 Mastering Microsoft OneNote for Notetaking and Team Collaboration

 

Category: GENERAL MGMT

Mastering Microsoft OneNote for Notetaking and Team Collaboration


 

 Mastering Microsoft® Project

 

Category: COMPUTERS / SW - Office Software

Plan, control and maximize project efficiency


 

 Mastering Powerpoint: Shortcuts and Tips to Create Presentations Like an Expert

 

Category: GENERAL MGMT

Mastering Powerpoint: Shortcuts and Tips to Create Presentations Like an Expert


 

 Mastering the 8 Tenets of Values-Based Leadership

 

Category: GENERAL MGMT - Leadership Skills

If You Want to Achieve Lasting Success, Let Your Core Values Lead the Way ...


 

 Mastering the Art of Critical Conversations

 

Category: COMMUNICATIONS

Attend this course and practice using real-life models to conduct difficult conversations on any topic. You’ll gain the skills and summon the courage to step up, speak openly and honestly, and get results that count.


 

 Mastering the Complexities of Executive Leadership

 

Category: GENERAL MGMT

Keys to driving extraordinary performance


 

 Mastering the Leadership Secrets of Remarkable People

 

Category: GENERAL MGMT - Leadership Skills

Don’t just be in charge, be a GREAT leader – we’ll show you how.


 

 Meeting Management: Using Meetings Effectively

 

Category: GENERAL MGMT - Meeting Management

Meetings are a crucial element of business, with millions being held all over the world every day, weather its through video teleconferencing or face-to-face.


 

 Mentoring Training

 

Category: GENERAL MGMT - Coaching/Mentoring/Counseling


 

 Method Development and Validation for Assays Supporting Testing of Biologics

 

Category: Compliance-Regulation

This 2-day seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE.


 

 PHR/SPHR Exam Prep Live Workshop

 

Category: HR MGMT - Training Development

Our instructor-led PHR / SPHR exam review program is designed to help Human Resources professionals pass the PHR or SPHR certification exam.


 

 Positive Behavior Strategies and Discipline Procedures for Students with Disabilities

 

Category: LAW - School Law

Our knowledgeable faculty will share information on changing laws and court decisions regarding who needs to be involved in disciplinary actions and how to correctly develop and implement a functional behavioral plan.


 

 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 for the Accidental Project Manager - A Basic "How to" Approach

 

Category: GENERAL MGMT

Project Management for the Accidental Project Manager - A Basic "How to" Approach


 

 Project Management in Human Resources - 3-Day Certification Program

 

Category: Compliance-Regulation

This three-day workshop is a practical and comprehensive introduction to the many facets of project management specifically designed for the human resource professional.


 

 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 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.


 

 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.


 

 Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and OSHA Focus)

 

Category: Compliance-Regulation

GLP requires many types of documents. The seminar covers both the general issues and many specifics that laboratories can receive a non-compliance on.


 

 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.


 

 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.


 

 Robust Quality System Approach to Pharmaceutical Products: Scientific Basis and Implementation of Current Regulations

 

Category: Compliance-Regulation

This course will provide an overview of some relevant rules and regulations concerning their scientific basis, development and interpretation.


 

 Secrets for Writing Excellent SOPs (Standard Operating Procedures) Webinar

 

Category: Compliance-Regulation

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work. This webinar will help you structure your QMS and develop accurate, clear, unambiguous SOPs.


 

 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 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 Auditing Analytical Laboratories for FDA Compliance

 

Category: Compliance-Regulation


 

 Seminar on Building a Fair and Equitable Pay Program

 

Category: FINANCE/INVESTING

This seminar is organized according to logical, sequential phases of a pay project. Each phase is subdivided into specific considerations or tasks, followed by a series of questions to help you analyze your situation.


 

 Seminar on Design of Experiments (DOE) for Process Development and Validation

 

Category: Compliance-Regulation

This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools which can be use pre and post DOE studies.


 

 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 Design Verification data and Process Validation 2016

 

Category: EDUCATION/TRAINING

This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results.


 

 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 Fundamental Laboratory Record Keeping and Compliance Issue

 

Category: Compliance-Regulation

This seminar will go through many of the compliance areas and point out some of both types. IF or those implementing GLP or striving to maintain certification, this course should point out many areas to cover that would lessen an unsatisfactory audit.


 

 Seminar on Geological Exploration 2016

 

Category: EDUCATION/TRAINING

We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures.


 

 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 HIPAA Security & Privacy Official - Roles and Responsibilities

 

Category: HEALTH CARE

This seminar will cover reviews, creation, and amending policy and procedure. After completing this course, a HIPAA Security and Privacy Official will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations.


 

 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 build a complete Safety, Health & Environment Management System through Standards & Practices

 

Category: HEALTH CARE

A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations.


 

 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 Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

 

Category: Compliance-Regulation


 

 Seminar on Lineament analysis and appropriate sampling and Quality Assurance/Quality Control (QA/QC) procedures to help you find your next mine

 

Category: LAW - Environmental Law


 

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

 

Category: Compliance-Regulation

This two day Seminar provides a conduit to enhance your understanding of the utilization of Process Validation and Phase 1, 2 and 3, where their Guidances blend and where they remain distinct.


 

 Seminar on Regulatory Requirements and Principles for Cleaning Validation

 

Category: Compliance-Regulation

This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.


 

 Seminar on Requirements for Establishing an Effective Cleaning Validation Program

 

Category: ENVIRONMENT

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.


 

 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 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 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 Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

 

Category: Compliance-Regulation

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.


 

 Seminar on Validation and Part 11 Compliance of Computer Systems and Data

 

Category: Compliance-Regulation

This 2-day interactive course provides the regulatory background and guides attendees through the complete equipment qualification and computer system validation processes from planning to reporting.


 

 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.


 

 SOP Writing, Training and Compliance in the Pharmaceutical Industry

 

Category: Compliance-Regulation

This course will also show you how to perform ongoing assessments of learners’ retention of knowledge of SOP content for continuous improvement and avoidance of procedural deviations, using the tools already available in your company’s training software.


 

 Strategic HR Leadership Certificate Program

 

Category: HR MGMT

The Strategic HR Leadership Workshop prepares HR professionals to excel as leaders in organizations of all sizes because it provides the vital knowledge and outlook needed to become a strategic leader


 

 The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products

 

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


 

 The Basics of Writing Policies and Procedures

 

Category: COMMUNICATIONS - Publications/Manuals

Sharpen your writing skills with the keys to keeping your text clear and concise


 

 The Challenges of an Effective Change Control Program and How to Address OOS Results

 

Category: Compliance-Regulation

In addition, the seminar will also highlight some of the benefits that a well maintained change control program provides to a company along with reviewing when change control is not required.


 

 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 Master Course for Today's Managers

 

Category: GENERAL MGMT

Become a cutting-edge forward thinker in all the areas crucial to successful leadership


 

 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.


 

 Time Management

 

Category: GENERAL MGMT - Time/Stress Management

Take control of your time…and get control of your entire workday!


 

 Understanding and Implementing a Quality by Design (QbD) Program

 

Category: Compliance-Regulation

This seminar will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization.


 

 Understanding and Implementing the New ICH/USP Elemental Impurity Guidelines

 

Category: Compliance-Regulation

In this two day workshop conference you will learn the different global agencies’ expectations of meeting the new guidelines. Different strategies for compliance will be presented with numerous illustrative examples.


 

 Validation and Part 11 Compliance of Computer Systems and Data

 

Category: Compliance-Regulation

Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use.


 

 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.


 

 World Class Cyber Incident Response Plans: Strong Responses to Attacks

 

Category: Compliance-Regulation

This course is intended for a varied audience as we explore the people, processes, and payment integrity aspects of responding to today’s cyber-threats.


 

 Writing HR Policies & Procedures

 

Category: MANUFACTURING/OPERATIONS - Facilities Mgmt

Can you really afford to take risks with the policies and procedures that guide your organization? We didn’t think so! That’s why we developed this intensive new training especially for HR pros like you!


 
 

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