'Fda inspection' diaporamas de présentation

Michael A. Swit, Esq. Law Offices of Michael A. Swit mswit@fdacounsel fdacounsel

Legal Strategies and Concerns in the Sourcing of FDA-Regulated Products, Components & Services Keys to a Win-Win Relationship with Your CMO. Michael A. Swit, Esq. Law Offices of Michael A. Swit mswit@fdacounsel.com www.fdacounsel.com.

548 views • 35 slides

Auditing for Compliance

Auditing for Compliance. It is important to periodically do self-inspections to assure that your policies, practices, procedures, etc. meet the minimum cGMP requirements. 1. Internal Audit Program. Trained auditors Know the regulations and requirements Report what they see

1.18k views • 25 slides

Lessons Learned from the Hydrolyzed Vegetable Protein Incident

Lessons Learned from the Hydrolyzed Vegetable Protein Incident. Jenny Scott FDA CFSAN Office of Food Safety. The Beginning. FDA was notified on 2/5/10 (Company A) and 2/6/10 (Company B) of Salmonella Tennessee in HVP produced by Company C.

401 views • 20 slides

Patricia Kerby, MPA Human Subjections Protection Compliance Officer Office of Research Compliance

333 views • 19 slides

FDA Inspections

541 views • 8 slides

FDA Inspection Policy and Best GMP Practices

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trend-today

The US FDA inspection of Sun Pharma's crucial Halol site in Gujarat that was widely expected to end on Friday, could possible extend by a day or two, said sources. The facility is under US FDA warning letter since December 2015.The drug maker declined to comment. Dilip Shanghvi, who is attending the India Pharmaceutical Forum, said the company as a policy will not talk on ongoing regulatory inspections. The current US FDA inspection began on February 12.

66 views • 6 slides

Webinar On Good Practices in Preparing for an FDA Inspection

This webinar is intended to help you get familiar with how to prepare for and get ready for an FDA inspection.

189 views • 2 slides