Preparing Stability Protocols for Development and Commercial Products
Instructor:
Peggy Berry
Product ID: 704459
- Duration: 90 Min
Why Should You Attend:
This webinar will demonstrate to attendees how best to create stability protocols for drug substance and drug product, including long term stability; accelerated stability and special stability studies (e.g., light or oxygen sensibility).
Areas Covered in the Webinar:
- Creating stability protocols
- Shipping protocols
- ICH and FDA specific requirements
- Updating the FDA with data during development and commercial phases
- Changing expiry dating with more data
Who Will Benefit:
- Manufacturing
- Supply chain
- Technical operations
- Quality control
- Quality assurance
- Regulatory affairs
Peggy Berry
Founder, Synergy Consulting LLC
Peggy J. Berry, MBA, RAC, is the president and 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 department. Prior to Insmed, she was vice president of regulatory affairs and quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held regulatory affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).
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