Stability Protocols during development & commercialization
Peggy J. Berry, MBA, RAC, is Keynote Speaker at ComplianceKey.She is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs departmen........
Overview
This webinar will teach you to create stability protocols for drug substance and drug product, including long term stability; accelerated stability & special stability studies (e.g., light or oxygen sensitivity).
Why should you attend this webinar?
Areas Covered in the Session:
- Contents of stability protocols
- Shipping protocols
- ICH recommendatons will be discussed
- Updating data during development & commercial phases
- CapitalizeSet expiration date based on data
Who can Benefit:
- Pharma & Biotech
- Quality Assurance, Quality Control (Chem and Mirco), Process and Design Engineering, Process Automation, Manufacturing Operations, Validation, Utility Operations, Regulatory Affairs.
