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Your search for 'QbD quality design analytical target profile ATP compendial requirements lifecycle approach development ICH Q2 USP 1225 method validation' training seminars workshops and conferences in US and Canada has produced the following results.
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AML Model Validation: A Critical Need in the New Regulatory Environment
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Category: BANKING Training Provider: Online Compliance Panel Participants will learn practical strategies to comply with the ADA while protecting the workplace from the negative impact of drug and alcohol abuse of its employees.
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Applying Computer System Validation to Mobile Applications Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Learn how computer system validation can be applied to mobile applications subject to FDA regulations, what are the best practices, trends in validation.
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Common Problems and Mistakes in Method Validation in Drug Development Process
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Validation of test methods is a critical requirement for the drug development process. Testing of drug substance and drug product for quality requires validated methods. In addition, testing samples for PK/PD studies requires methods that are consistent, robust, rugged, sensitive, and specific in a variety of matrices. Collecting sufficient data prior to validation that can reliably support acceptance require is a frequent issue. Setting appropriate acceptance criteria based on data from final development and qualification is important for assay performance in the validation. This webinar will address issues that arise during development and validation that lead to failure and rework. The webinar also includes approaches to validation that can prevent failure and increase successful completion of validation.
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Developing a Validation Master Plan Webinar
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Category: MEDICINE/NURSING Training Provider: Online Compliance Panel Attend this live training session to learn what is a VMP and how is it valuable to your company, how the VMP is controlled and updated, VMP best practices.
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Equipment Validation, Tracking, Calibration and Preventive Maintenance
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This session will review the regulatory requirements for validation, including detailed review of IQ, OQ, and PQ. A sample validation process will be followed through each phase. Documentation requirements for both protocol and results will be reviewed along with a list of pitfalls to avoid in documenting your validation. The importance of the Master Validation Plan will be discussed too. Preventive maintenance will be covered, including how to assure it does not adversely impact validated processes. A cost-effective equipment calibration program will be featured as well.
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Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases.
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Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel In this Live Webinar, the speaker will walk you through the major areas of a plant, including the facilities, utilities and equipment in a critical manner to link best practices to the overall expectations of the agencies. That is the facilities, utilities and equipment design, construction, commissioning and start-up to the objective of assuring that they will lead to successful operations to yield consistent, reliable production free from cross contamination: the overall objectives of all regulatory bodies. We will focus on the qualification of these systems to assure this contributes to successful operations through the lifecycle of the plant and its operations. We will discuss strategies to operate efficiently, yet compliant in a risk based approach driven by data and scientifically driven means.
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FDA Regulations for Analytical Instrument Qualification and Validation Processes Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors.
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Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it. - By Compliance Global Inc.
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Category: Compliance-Regulation Training Provider: Compliance Global Live webinar on Computer Systems Validation Regulations and Compliance issues during System implementation
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IQ, OQ, PQ in the Verification and Validation Process
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.
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Key Considerations in Verification & Validation of Medical Devices Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This webinar will cite what are the key considerations in medical device design and validation that can help prevent FDA 483s.
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Master Validation Plan - A Complete Package Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Get guided on how to develop and implement a good plan detailing responsibilities and deliverables to make validation efficient and consistent.
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Monitoring and Validation of Pharmaceutical Water Systems
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled for impurities. Pharma water systems must be designed, validated and monitored to ensure that the water produced meets specifications around the clock. Learn common pitfalls with water system design and use and how to avoid them. Get your pharma water questions answered in this webinar.
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Policies and Procedures Required to Support Validation of Computer Systems Regulated by FDA Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Learn policies and procedures required to support activities related to computer system validation for systems subject to FDA regulations in this webinar.
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Process Validation - Current Industry Practices and FDA Guidance Document Review Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities. In this webinar, the basics of process validation will be explored along with current industry practices. The recent draft FDA Guidance Document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols.
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Quality Systems Approach for Validation and Maintenance of a Global ERP System Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel In the pharmaceutical industry and many other industries it is recognized that there is an increasing dependence upon automation. As a result, many companies are adopting different approaches to keeping their Enterprise systems compliant.
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Risk Based Approach to Software Quality Validation Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Learn to develop procedures for including Risk Management in software quality validation 59; risk management standard operating procedure development and maintenance, more
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Software Verification and Validation in Medical Industry - By Compliance Global Inc.
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Category: Compliance-Regulation Training Provider: Compliance Global Webinar On Validation in Medical Industry for The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA
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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements Webinar
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Category: MEDICINE/NURSING Training Provider: Online Compliance Panel It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs to differ based on the filtration requirement.
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Test Method Validation to Verify your Device Performance Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.
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The Best Way to Develop or Improve a Master Validation Plan - By Compliance Global Inc.
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Category: Compliance-Regulation Training Provider: Compliance Global Training On Master Validation Plan for U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements
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Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Total Organic Carbon (TOC) is a useful analytical method for cleaning validation studies, including design, qualification and routine monitoring. While there may be some confusion with the industry and regulatory bodies about the use of this analytical technique, it is widely used because of certain benefits. The basis of TOC as an analytical technique will be covered, involving the various technologies currently utilized. Cautions in sampling and analyses will be discussed, including the appropriate use of blank and controls.
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Validation of Complex Cell- Based Potency Methods Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Acquire knowledge on complex cell-based methods, selection of the method and the cell line, and correlating the method with the pharmaceutical activity.
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