FALLS CHURCH, Va. (PRWEB)
May 12, 2022
FDA’s Alternative Inspection Tools:
Expert Answers to Drug and Biologics Manufacturers’ Questions
https://www.fdanews.com/products/62599
Get ready for the FDA to ramp up its good manufacturing practice (GMP) inspections, with what will likely be permanent changes to its methods. If drugmakers aren’t getting ready now, they won’t be prepared for the next inspection.
Based on insights from seven inspections experts, six of whom are former FDA officials, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions explains everything needed to know about how FDA inspections are changing and exactly what and how they must be addressed.
Its useful question-and-answer format takes readers through these new remote methods that are designed for efficiency. They’ll understand the implications and know how to navigate it all to stay compliant, from an explanation of the FDA’s new approaches and their statutory authority to how the agency will carry of 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 drugmakers want to pass their next inspection, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions is a must.
Management Report Details
FDA’s Alternative Inspection Tools:
Expert Answers to Drug and Biologics Manufacturers’ Questions
https://www.fdanews.com/products/62599
Price:
$397
Easy Ways to Order:
Online: https://www.fdanews.com/products/62599
By phone: 888.838.5578 or 703.538.7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.
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