CONFERENCE SPOTLIGHT

Cleaning and Cross-Contamination Case Study

Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends over recent years and provided in-depth case studies from Current Good Manufacturing Practice (CGMP) inspections. This first study, presented here, focuses on cleaning and cross-contamination issues with an encapsulator.

Did COVID-19 Kill Just-in-Time Pharma Supply Chains?

The full impact of the pandemic has yet to be felt, and the intricate and proprietary nature of pharma supply chains prevents an overall industry analysis.  Considering the current reality, is the JIT model now dead or dying in the pharma industry?

CDRH Reorganization Takes a Total Product Lifecycle Approach; MDSAP, ISO Adoption, and Collaboration with MDIC Moving Forward

In the third report from December’s FDLI Enforcement, Litigation, and Compliance Conference, CDRH’s Associate Director for Compliance and Quality Erin Keith explains the Center’s completely revamped organization structure that was finalized late last Fall, its progress on international harmonization efforts, and the changing face of its compliance program.

Scuba Divers

What a Scuba Diving Incident Can Teach Pharma About Quality Systems

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, Procter & Gamble Quality Leader and Leadership Coach Steve Greer provided a compelling, true story about a scuba diving incident and used the lessons learned as an analogy for how to ensure that pharma quality systems function properly.

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