FDA’s Guidance on Drugs and Biologics During COVID-19 – Webinar Recording/Transcript
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If complying with the more than 50 recent FDA guidance documents that govern drug development and manufacturing safety related to the coronavirus, COVID-19, has been a challenge, consider this your lifeline.
SARS-CoV-2, the virus that causes COVID-19, has necessitated a myriad of changes to drug development methods, current good manufacturing practices (cGMPs) and inspections.
The flurry of guidances the FDA has released in response make compliance that much more difficult. So, you risk serious delays bringing much needed preventative and therapeutic drugs to market.
In this presentation, consultant Keith Webber, Ph.D. will share the FDA’s most important coronavirus-related guidance you must adhere to if you want to remain compliant. He has an insider’s understanding of where the agency is coming from, having spent 18 years in high-level positions within it, including as director of the Office of Pharmaceutical Science.
This is your opportunity to get a handle on the most critical guidance documents on drug development methods, good manufacturing practices (GMPs) and FDA procedures.
- Comply with supply chain drug and biologic inspections
- Comply with exemptions from supply chain security
- Comply with GMP manufacturing considerations
- Comply with guidance on COVID-19 drugs (for treatment or prevention)
- Comply with vaccine guidance (development and licensure)
Focus on the most-important SARS-CoV-2 related guidance addressing drug development, cGMPs and inspections. Or your products and processes will fall short.
Meet Your Presenter
Keith Webber, Ph.D. has served at the U.S. FDA in both the Center for Drug Evaluation and Research and the Center for Biologics. During his 18 years with the agency, his roles included director of the Office of Pharmaceutical Science, director of the Office of Biotechnology Products and director of the Office of Generic Drugs. His industrial experience also includes serving as the vice president of biotechnology at Lachman Consultant Services, Inc., as well as senior director of Rx regulatory affairs at the Perrigo Company.
Who Will Benefit
- Regulatory Affairs Personnel at Pharmaceutical Companies
- Manufacturing Personnel at Pharmaceutical Companies
- Quality Assurance Personnel at Pharmaceutical Companies
- Pharmaceutical Consultants
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Oct. 20, 2020