GMP Requirements for Validation and Re-Validation of Analytical Procedures

This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.

Why Should You Attend:

New medicines are developed every day to meet medical needs and improve quality of life. Analytical procedures are used to establish acceptance criteria and monitor quality of drug products. Therefore, validation becomes a critical process especially with the changes throughout the drug development process. It is important to understand validation requirements set forth by ICH and GMPs.

This webinar will present the common deficiencies in relation to method validation, outline regulatory requirements and the change control process needed to stay in compliance.

Learning Objectives:

Upon completion of this session, attendees will understand cGMP and ICH validation requirements for analytical procedures and learn key factors that would affect validation process of analytical procedures. It would help scientists to develop process to evaluation method validation, review changes, and determine when re-validation would need to take place. It will discuss observations and infractions related to method validation.

Areas Covered in the Webinar:

• Deficiencies related to Method Validation.
• Factors affecting Quality of Medicines.
• Validation Characteristics
• Validation vs Re-Validation plan
• Tracking record of validation project.
• Change control of validation

Who will Benefit:

• Senior management in pharmaceutical analysis
• Pharmaceutical scientists
• Analysts and lab managers
• QA managers and personnel
• Regulatory affairs
• Contract research laboratories

Instructor Profile:

Kim Huynh-Ba, has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.