How to Prepare for an FDA Inspection?
Instructor:
Loren Gelber
Product ID: 705878
Training Level: Intermediate
- Duration: 90 Min
Why Should You Attend:
All manufacturers of FDA-regulated products, including drugs, foods, cosmetics, medical devices and veterinary products, are subject to the requirements to FDA inspection. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. The prudent firm will prepare itself for such inspections, using methods such as those to be discussed in this webinar. While this webinar will focus on pharmaceutical requirements, the concepts to be discussed will be applicable to all FDA regulated products.
This webinar will give employees concepts that they can apply to their particular firm in preparing for FDA inspections. It is prudent for all FDA-regulated firms to appoint a group of employees to prepare for FDA inspection. The members of this group require training in how to prepare for an FDA inspection. The consequences of a “failed” FDA inspection (one classified by FDA as OAI) can be quite severe.
Areas Covered in the Webinar:
- General Information about FDA Inspections
- Inspection Classification
- Planning for Inspections
- Self Audit Process
- Practice or Mock Inspections
- Corrections
- Responding to inspectional observations
- FDA Warning Letters and 483s (What not to do)
Who Will Benefit:
- Quality
- Regulatory Affairs
- Manufacturing
Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)
Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She participated in the development of method validation requirements for HPLC analytical methods. She then transitions to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.
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