FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions
Want to get all your inspection questions answered by former FDA officials? You can, with FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions.
The FDA is ramping up its good manufacturing practice (GMP) inspections to catch up with the pandemic-induced backlog — with what will likely be permanent changes to its methods. If you’re not getting ready now, your chances of a successful inspection are slim.
Based on insights from seven inspections experts — six of whom are former FDA officials — FDA’s Alternative Inspection Tools explains everything you need to know about how FDA inspections are changing and exactly what and how you must address them.
Its useful question-and-answer format takes you through these new remote methods that are designed for efficiency. You’ll understand the implications and know how to navigate it all to stay compliant, including: an explanation of the FDA’s new approaches and their statutory authority, consequences when some of these new procedures turn up potential problems, how preparing for a remote inspection is different from getting ready for an onsite inspection, how quickly the agency will be able to return to its normal inspection workflow and how the agency will carry these new tools into the postpandemic era.
Management Report Takeaways:
- When a records request is mandatory vs. voluntary
- How preparing for a remote inspection is different from getting ready for an onsite inspection
- How to respond nimbly to FDA records requests and share them securely
- Whether the FDA will classify the results of a Remote Interactive Evaluation (RIE) since it won’t issue a 483
- Can/will the FDA use RIEs in place of onsite inspections?
- How the FDA may use Mutual Recognition Agreements with other countries to lighten the inspection load
If you want to pass your next inspection, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions is a must.
About the Contributors
- Cynthia Schnedar, Principal of Regulatory Compliance, Greenleaf Health; former Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
- Kalah Auchincloss, Executive Vice President of Regulatory Compliance, Greenleaf Health; former Deputy Chief of Staff, FDA
- David Chesney, Principal, DL Chesney Consulting; former San Francisco District Director, FDA
- Steven Lynn, Executive Vice President of Pharmaceuticals, Regulatory Compliance Associates; former Director, Office of Manufacturing and Product Quality, Center for Drug Evaluation and Research, FDA
- Robert Rhoades, Managing Partner, Validant
- Jonathan Gil, Senior Corporate Counsel, Pfizer; former Regulatory Counsel, Office of Compliance, Center for Drug Evaluation and Research, FDA
- Daniel Barreto, President and CEO, PharmQ Global Consulting; former Supervisory Investigator, FDA
Who Will Benefit
- Quality unit personnel
- Regulatory compliance professionals
- Legal professionals
- Facility managers
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Cynthia Schnedar, Kalah Auchincloss, David Chesney, Steven Lynn, Robert Rhoades, Jonathan Gil and Daniel Barreto
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