US FDA's Pre-Approval Inspection Program

Why Should You Attend:

The US FDA has the responsibility of ensuring that all products subject to approval for marketing in the United States comply with Good Manufacturing Practices and the information contained in the respective applications are factual and accurate. FDA uses its inspection authority as a tool in ensuring that products included in an application are manufactured under GMPs and to ascertain the accuracy of supporting data. In this regard FDA has developed a Pre-Approval Inspection Program.

This presentation, by a former USFDA executive, will give an insider’s insight into the pre-approval inspection program and discuss the rationale for such. This training will provide valuable assistance to those companies and professionals involved in producing therapeutic products and having applications pending with the US FDA, and those companies contemplating submitting applications to the US FDA.

Areas Covered in the Seminar:

• Background and Rationale for Program
• Scope.
• CGMP Statutory and Regulatory Requirements.
• Roles and Responsibilities.
• Criteria for Inspections.
• Inspection team.
• Inspectional Approach and Systems.
• Questions.

Who Will Benefit:

The employees who will benefit include:

• Management
• Production Employees
• Quality Control Managers and Personnel
• Process Chemists and Personnel.
• Laboratory Personnel.
• Regulatory Affairs Personnel

Instructor Profile:

Sandra N. Whetstone, is a former (retired) US Food and Drug Administration (FDA) executive. She has more than 35 years of experience as a US Food and Drug official and is a recognized expert in US Food and Drug Law, the Public Health Service Act and related statues. Mrs. Whetstone is a co-founder and Managing Director of Comprehensive Compliance Solutions, LLC, a consulting company specializing in all aspects of FDA regulatory compliance matters relative to human and veterinary drugs, biologics, medical devices and foods. She has developed and presented cGMP training courses for Phase 1 and Phase II pharmaceutical manufacturers.

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