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Reports on key industry issues by our GxP Experts

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Recent Posts

Inadequate Media Fills at a Sterile Manufacturer: CGMP Case Study by FDA National Drug Expert Ileana Barreto-Petit

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

FDA National Drug Expert Ileana Barreto-Petit presents an in-depth analysis of the findings, lessons learned, and how companies can avoid similar findings in regard to a CGMP inspection case study. This case study involves a large, foreign manufacturer of injectable drug products. The product in question is a combination product.

Champion of Change – 3Cs to Success

Join Govzilla and corporate QA External Engagement Leader, Keynote Speaker, and Leadership Coach, Steve Greer, for an empowering webinar on being a Champion of Change and using the 3Cs to Success in your personal life and organization.  

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.

What is risk-based thinking, and how can you apply it in your organization?

What is Risk-Based Thinking?

What is risk-based thinking? And how can you apply it in your organization? Industry veteran and risk expert Ernest Blanchard explains.

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