The FDA Group

The Life Science Rundown

Science EN ↓ 78 episodes

The Life Science Rundown is a podcast for life science professionals hosted by The FDA Group. We dive deep into topics across the RA/QA/Clinical space, covering news, exploring trends, and picking the brains of expert guests.

Author

The FDA Group

Episodes

What RA/QA/Clinical Leaders Should Expect From the FDA in 2021 16.12.2020 43:07

The FDA Group’s CEO, Nick Capman , sits down with Ben Locwin , Senior Consultant for Public Health Outreach at the CDC, and Executive Advisor for Valeocon Management Consulting, to discuss what life science leaders should expect from the FDA in 2021 as it pertains to quality system management, regulatory approvals, GxP compliance, and more. Ben has extensive experience working with the FDA and int...

Inside FDA Pre-Approval Inspections with Former FDA Investigator, Christopher Smith 12.11.2020 51:26

The FDA Group’s CEO, Nick Capman, sits down with Former FDA Investigator, Christopher Smith to dive deep into FDA Pre-Approval Inspections (PAIs). Chris has more than 35 years of experience having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations.  Learn how PAIs are planned and conducted, how to prepare for them, and where to go t...

A Look at FDA's Pandemic Inspections Q&A Guidance 12.11.2020 4:49

The FDA Group’s CEO, Nick Capman, breaks down the FDA’s Q&A guidance on drug and biologic inspections during the pandemic, pointing out the important takeaways manufacturers should consider and prepare for. Read our blog post for a written breakdown of the key takeaways. We've also written on FDA's more recent guidance outlining its expectations for resuming normal manufacturing operations dur...