In the webinar, gain the skills for practical implementation of regulatory requirements for Pharma/Biotech raw material selection, receipt, testing, storage, and use in production.
Why Should You Attend:
This presentation 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. By the end of this program, you will understand the requirements for raw material selection, receipt, testing, storage, and use. Guidance and skills for practical implementation of regulatory requirements will be presented.
The program will address approaches to selecting primary and secondary suppliers of raw materials, developing an incoming receipt and testing process, adequate and appropriate storage, and other considerations for the raw materials used in drug product processing. The information obtained will also enable completion of the raw material information in Module 3 of a CTD application.
Areas Covered in the Webinar:
Who Will Benefit:
The following professionals from Pharmaceutical and Biotech Industries:
Quality Assurance, Quality Control (Chem and Micro), Process and Design Engineering, Process Automation, Manufacturing Operations, Validation, Utility Operations, Regulatory Affairs.
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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 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).