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. Join us by registering today.