Keeping your analytical method in compliance with Good Manufacturing Practices (GMPs): Validation, Verification and Transfer
October 2, 2018 - Montreal ON CAInternational Pharmaceutical Academy (IPA)
rebecca@ipacanada.com
Phone:4164107402
Analytical laboratories play important roles in the pharmaceutical industry. The generation of data under conditions that ensure its reliability and allow for post-analysis verification of its authenticity is critical to the drug development process; therefore, keeping the analytical method in compliance with validation requirements and product changes is a challenge for analytical scientists. This course will review the current regulations, provide updates from FDA, ICH, USP, and WHO, and different aspects of validation throughout development phases to establish critical acceptance criteria. It will also discuss different strategies to transfer an analytical method systematically. Participants should expect to share their experiences and discuss Best Practices to keep method stay in compliance with Good Manufacturing Practices (GMPs). One Day Interactive presentation, case studies and exercises on: - Regulatory expectations of Method Validation - Development of stability indicating test methods - Documentation of Method Validation - Method Transfer Process - Interactive discussions on Method Transfer issues