Former FDA inspector Steven Niedelman discusses the basics of FDA inspections in a Govzilla webinar.
FDA Warning Letters Week of 07/26/20: Unapproved HCT/P & OCT Products, Repeat Deficiencies, & Testing into Compliance
This week the FDA posted two warning letters to firms that sold cord blood products without having an active IND or approved BLA. There were also two warning letters posted to the manufacturers of OTC drug products.
Procter and Gamble’s Steve Greer discusses his company’s experience participating in the FDA Quality Metrics Site Visit Program.
FDA Warning Letters Week of 07/19/20: Data Integrity, Unapproved New Devices, & Repeated Failures at Multiple Sites
This week, FDA posted two warning letters to drug manufacturers and one to a device manufacturer. The warning letter to Stason Pharmaceuticals (Irvine, CA) includes the most granular list of requested data integrity remediation activities that I’ve seen FDA provide, to date.
Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
In Part 4 of our series on virtual agency inspections, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection, including best practices, how to adjust your logistics, and how to prepare for a closeout meeting.
Join Jason McGuire, Global Quality Director at Fagron, and Jerry Chapman, Govzilla Senior GMP Quality Expert as they host an informative webinar with Govzilla on 503B outsourcing and how they deliver personalized medicine and mitigate drug shortages.
Preparing for a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
In Part 3 of our series on virtual agency inspections, former FDA investigator Ricki Chase provides her insight into the best way to prepare for virtual inspections, including how to always be ready, how to go about reviewing documents, and which documents FDA is likely to request for review.
This week FDA posted two warning letters to device manufacturers and two to drug manufacturers. One of the drug manufacturers produces homeopathic drugs, which continues FDA’s focus on this area of the industry.
A State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector
Part 2 of this series focuses on Thermo Fisher Scientific and its use of virtual reality and mixed reality platforms to create a state-of-the-art system that it has successfully used in virtual inspections, including with both clients and the European Medicines Agency (EMA).