FDA Compliance and Quality inspections

This presentation will focus on FDA’s current thinking on cGmp requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act, FDA’s inspectional procedures and process, what firms can do to facilitate and prepare for inspections, FDA’s new approach utilizing quality systems and current FDA 483 findings.

Areas Covered in the seminar:

• Overview of FDA’s statutory inspectional obligation, new inspectional approach for the pharmaceutical industry
• Background on FDA’s inspection authority
• FDA’s inspectional procedures and process
• How to prepare for the inspection
• How to facilitate the inspection
• What the inspection will cover
• FDA’s New Inspectional Approach
• Common GMP deficienceis and recent 483 findings

Who will benefit:

This webinar will provide valuable assistance to those firms and individuals who are regulated by the U.S. Food and Drug Administration and subjected to FDA inspections and oversight. The employees who will benefit include:<.p>

• Management
• Production Employees
• Quality Control Managers and Personnel
• Laboratory employees

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 various segments of the pharmaceutical industry.

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