FDAnews Announces The Preapproval Inspection: Passing the FDA’s GMP Test Management Report

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Get new drugs to market faster: prepare for the FDA’s rigorous preapproval inspections (PAIs) to secure NDA/ANDA approvals.

WCG FDAnews

WCG FDAnews

The Preapproval Inspection:
Passing the FDA’s GMP Test
https://www.fdanews.com/products/category/224-drug-books/product/61037-the-preapproval-inspection-passing-the-fdas-gmp-test

How does one prepare for the FDA’s more rigorous preapproval inspection (PAI) for new drugs?

The PAI goes well beyond a typical good manufacturing practices (GMP) inspection. The FDA’s objectives are highly targeted and its updated procedures are much more challenging.

If FDA investigators find problems in your manufacturing operations, a new drug application (NDA) or abbreviated new drug application (ANDA) will not be approved.

The Preapproval Inspection: Passing the FDA’s GMP Test management report shows how to review GMP compliance for gaps; review FDA applications with an eye for what agency investigators will look for; conduct a mock PAI to train staff to handle the real thing; how the FDA trains its inspection teams to conduct PAIs; what happens after the PAI, including responding to a 483; and how the FDA makes the decision to approve — or withhold approval — based on PAI findings.

This report provides all the information one needs to handle a PAI successfully, explaining:

  • The four steps to preapproval inspection (PAI) preparation
  • The FDA’s three PAI objectives
  • How to develop a PAI standard operating procedure (SOP)
  • What FDA investigators can do and see during an inspection
  • How to respond to a Form 483
  • How to conduct a mock inspection
  • The do’s and don’ts of handling a PAI

If one is preparing to submit an NDA or ANDA, one will need The Preapproval Inspection: Passing the FDA’s GMP Test to prove that one’s manufacturing operation can produce a safe, high-quality drug product.

Management Report Details:
The Preapproval Inspection:
Passing the FDA’s GMP Test
https://www.fdanews.com/products/category/224-drug-books/product/61037-the-preapproval-inspection-passing-the-fdas-gmp-test

Price:
$397 per site

Easy Ways to Order:
Online: https://www.fdanews.com/products/category/224-drug-books/product/61037-the-preapproval-inspection-passing-the-fdas-gmp-test
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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Michelle Butler
FDAnews
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