FDA Inspection Handbook
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The FDA Inspection Handbook is a comprehensive review of the entire investigation process, not only from the company's side, but from the investigators' side as well. It covers the scope, consequences and actions for all types of FDA inspections. The Inspection Handbook gives you an in-depth look at the actual investigation, the documentation needed, the affidavits, how to deal with the aftermath, and links to regulations, key documents, statutes and limitations. You'll know how to prepare and what to expect.
- With the FDA Inspection Handbook, you can:
- Have a complete overview of the FDA authority in dealing with inspections, how they prepare, what they will be looking for, and the trends the professionals have been seeing
- Have a comprehensive understanding of what the FDA has the right to request, the documents you'll need, collection of samples and affidavits from employees
- Understand a 483 - the timing, your response and what to expect afterward
- Consult specific sections for clinical trials and medical device inspections
- Additional links to support documentation and regulations
The FDA Inspection Handbook is a must have for any company or individual that deals with regulation and inspection issues. It brings you an in-depth look at the investigation process from start to finish, with a review of the FDA authority, and the reasons and triggers for an investigation. The Inspection Handbook clearly spells out for you the scope, consequences and actions for any type of FDA inspections. You'll never be taken by surprise.
The FDA Inspection Handbook covers not only food and drug concerns, but has specific sections covering clinical trials, foreign facility inspections and medical device inspections.
With the new Inspection Handbook you'll have a complete understand of the key documentation needed, the affidavits, and the power of the FDA. You'll be armed with statistics, sample warning letters, and responses and timing to answering a 483.
FDA Inspection Handbook is available in eBook format.
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