This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this relative to the drug development process and have each expanded method validation requirements in recent years. However, with only limited guidance, industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC.
Whether involved in method development, method validation, method verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements. Lectures will include some of the more common mathematical and statistical treatments of validation data. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions. Methods utilized for the analysis of pharmaceuticals generate critical data in the determination of a product’s safety, identity, strength, purity, and quality. It is essential that the quality of the data is assured. Validation is required to demonstrate that these analytical methods are fit for their intended use. The validation data is also required by regulatory agencies for submissions.
This course will provide a thorough review of regulatory guidelines on method validation and transfer. Each element required to have a complete and thorough method validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement.
A review of validation protocol requirements and selection of appropriate acceptance criteria will also occur during the webinar session; as well as, a discussion on how to select suitable statistical calculations for reporting and interpreting the data.
Topic 1: Regulatory Requirements/Guidance on
Topic 2: Analytical Method Pre-Validation – Stage 1
Topic 3: Analytical Method Validation Characteristics – Stage 2
Topic 4: Test Method Validation Protocol
Topic 5: Test Method Validation Report
Topic 6: Regulatory Concerns About Test Method Validations
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this relative to the drug development process and have each expanded method validation requirements in recent years. However, with only limited guidance, industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC.
Whether involved in method development, method validation, method verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements. Lectures will include some of the more common mathematical and statistical treatments of validation data. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions. Methods utilized for the analysis of pharmaceuticals generate critical data in the determination of a product’s safety, identity, strength, purity, and quality. It is essential that the quality of the data is assured. Validation is required to demonstrate that these analytical methods are fit for their intended use. The validation data is also required by regulatory agencies for submissions.
This course will provide a thorough review of regulatory guidelines on method validation and transfer. Each element required to have a complete and thorough method validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement.
A review of validation protocol requirements and selection of appropriate acceptance criteria will also occur during the webinar session; as well as, a discussion on how to select suitable statistical calculations for reporting and interpreting the data.
Topic 1: Regulatory Requirements/Guidance on
Topic 2: Analytical Method Pre-Validation – Stage 1
Topic 3: Analytical Method Validation Characteristics – Stage 2
Topic 4: Test Method Validation Protocol
Topic 5: Test Method Validation Report
Topic 6: Regulatory Concerns About Test Method Validations
Kelly Thomas
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
The Anti-Kickback Statute: Enforcement and Recent Updates
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Wage & Hour Laws: Ensuring Compliance with the Fair Labor S…
Expense Reimbursements 2026 - Proper Recordkeeping and Acco…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Claude AI For CPAs & Finance Professionals: Best Practices …
Dealing With Difficult People: At Work & In Life
Construction Lending And Real Credit Administration: Evalua…
Mastering the Prompt: How Every Professional Can Use AI to …
Secrets Of The Staffing Fix - Solving The Employee Training…
Eliminate Harmful And Unproductive Drama In The Workplace
Setting SMART Goals & Leveraging Storytelling for Reporting
Using Copilot to Format Legal Documents in Microsoft Word
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Discover how Emotional Intelligence turns AI from a technic…
Introduction to Microsoft Power BI Dashboards
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Major cGMP Issues: FDA Concerns in 2026
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
6-Hour Virtual Boot Camp on Microsoft Power BI
Managers/Supervisors: New Role, Same Team - How to Lead Wit…
HR Auditing - New Update on Important Issues for 2026
2-Hour Virtual Seminar on In-Person Onboarding Your New Hir…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Project Management for administrative professionals
Creating Employee Handbooks that Protect You and Support th…
California Meal and Rest Breaks: What You Don't Know Can Co…
Tools for New Managers: Connecting with Employees to Optimi…
Female to Female Hostility @Workplace: All you Need to Know
Launch Your Career: The Ultimate Guide for Emerging Profess…
Managing Difficult Employee Conversations
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Practice Safe Stress ™: Preventing Burnout While Building R…
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Rewiring Your Emotional Triggers: Leading with Clarity and …