July 28, 2020
Conference Spotlight
Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
July 23, 2020
Conference Spotlight
Preparing for a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
July 16, 2020
Conference Spotlight
A State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector
July 9, 2020
Conference Spotlight
Yes, FDA is Still Performing Pharma Inspections, Using Risk-Based Criteria: What is Your Risk for Inspection?
July 2, 2020
Enforcement
FDA Warning Letters Week of 06/21/20: For-Cause Inspection & Untitled Letter From A 2018 Inspection
June 30, 2020
Conference Spotlight
Microbiological Issues with Aseptic Processing and Lyophilization: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit
June 25, 2020
Conference Spotlight
Inadequate Media Fills at a Sterile Manufacturer When Starting up After a Shutdown: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit
June 18, 2020
Conference Spotlight
Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit
June 11, 2020
Conference Spotlight
David Doleski Encourages Industry to Participate in FDA’s Emerging Technology Efforts; Sanofi Case Study Reviewed
June 9, 2020
Enforcement
FDA Warning Letters Week of 05/24/20: Sterile Drugs, OTC Products, & Hiring of Quality Consultants
June 2, 2020
