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FDA Conference on Enforcement Trends

Speakers discussed details of the new enforcement powers granted by the 2007 FDAAA, tougher individual penalties for executives in FDA-regulated industries, recent enforcement trends, targets for 2008-2009, and advice on recognizing red flags before the FDA does.

 

This 18-page report details specific FDA recommendations from 10 officials on:

• Executive liability for noncompliance by employees and contractors

• The role of healthcare providers and company employees in post-market surveillance

• Deciding when and how to recall product - and what to document

• What to expect when FDA reviews your CAPAs and MDRs

• Four key components of a proactive compliance infrastructure

• Why SOPs need to clarify when your product is no longer in your control

• How to handle medical device complaints, service requests and software

Download a sample page.  (PDF, 176kb)

 

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Price: $89 (USD)

Contents

• Enforcement numbers from 2007

• Executive liability

• Compliance officer liability

• Civil monetary penalties

• Advertising and promotion scrutiny

• Unapproved claims

• Human cells, tissue and hormones

• Food enforcement trends

• Enforcement triggers

• Response timelines to the FDA

• Clinical trial inspection expectations

• Clinical trial data quality

• Clinical sponsor accountability

• Inspector expectations for corrective and preventative actions (CAPA)

• Corporate disciplinary expectations for internal noncompliance

• Recall and medical device reporting guidance

• Handling service requests and Part 11 compliance for medical devices

• Recall communications guidance

• Recommendations for proactive compliance infrastructure

• Considerations for use of consultants and outside experts

 

Additional Details

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