Comparability Protocols for approved drugs
Peggy J. Berry, MBA, RAC, 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, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior-level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.
Attend this training to determine whether or not a comparability protocol will provide you with future advantage in product life-cycle management.
Who Should Attend
Quality Assurance, Quality Control (Chem and Micro), Process and Design Engineering, Process Automation, Manufacturing Operations, Validation, Regulatory Affairs
This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing.