FDAnews Announces — New Management Report — The FDA’s New Inspection Practices: A Guide for Drugmakers

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The FDA’s New Inspection Practices: A Guide for Drugmakers explains the FDA’s plans for upgrading its inspectorate and provides the key resources manufacturers will need to prepare for their next inspection.

The FDA’s New Inspection Practices: A Guide for Drugmakers explains the FDA’s plans for upgrading its inspectorate and provides the key resources manufacturers will need to prepare for their next inspection.

The next inspection will not be like the last one.

The FDA is changing the way it handles inspections. Even if a manufacturer passed an inspection before, new requirements and new inspection practices can leave them exposed to enforcement.

So, what’s in store for a future inspection?

Under the FDA’s new inspectorate reorganization, the agency will send a team of highly trained and specialized investigators to the facility. These investigators will be experts in the specific manufacturing processes a manufacturers uses and they will know exactly where to look for and find problems.

The FDA’s New Inspection Practices: A Guide for Drugmakers explains the FDA’s plans for upgrading its inspectorate and provides the key resources manufacturers will need to prepare for their next inspection. Readers will learn:

  •     How each of the three ORA inspectorate programs, pharmaceutical quality, biological products and bioresearch monitoring, will be reorganized
  •     The latest resources FDA investigators use to train and prepare for inspections
  •     The top 483 citations in 2016:a roadmap to what investigators are looking for

Get ready for the next inspection and understand the newly revised procedures, guidances, compliance program guides, field management directives with The FDA’s New Inspection Practices.

Who Will Benefit:

  •     Quality manager
  •     Senior staff
  •     Line supervisors
  •     Legal counsel

FDAnews Management Report Details:
The FDA’s New Inspection Practices:
A Guide for Drugmakers
Price: $397
http://www.fdanews.com/products/54729-fdas-new-inspection-practices    

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54729-fdas-new-inspection-practices            
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.

The FDA’s New Inspection Practices:
A Guide for Drugmakers
**An FDAnews Management Report**
http://www.fdanews.com/products/54729-fdas-new-inspection-practices

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Michelle Butler
FDANEWS
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