FDA Records Retention Requirements – GLP, GCP, GMP, QSR

$349.00

Summary

Retaining the wrong records – or the right records for too long – is a recipe for FDA 483 observations, warning letters, civil money penalties and marketplace delays that will cost you over $8,000 a day to fix.  Since 2008, more than 90% of FDA Warning Letters cite record and document problems.  And if it’s not FDA, then it’s lawsuits from product liability claims and disgruntled investors.  All of which will cause you to pay a lawyer $103 to review each document you … or the court … finds.

Learning points

  • What the FDA expects when it comes to records retention
  • How to handle regulatory conflicts between state, US and international rules
  • The costly risks a firm runs with poor records management controls
  • How to identify the documents to retain … and those to toss
  • What to require from suppliers, employees and onsite contractors
  • How to build in records retention checks in your SOPs and quality system forms
  • What a cost-effective retention roadmap looks like – and how to get there

And much more

Get 11+ documents for easy & quick implementation

  • Worksheet:  9 pages of required FDA records and retention times
  • Checklist:  Organizational records controls
  • Checklist:  Technological records controls
  • Template:  Sample records retention schedule
  • 11-step FDA records retention implementation guide
  • Policy framework for tying into a quality management system
  • Sychronized audio-visual recording
  • Slides with room for your own notes
  • Customizable training certificate
  • FDA presentation about record retention and integrity:  Steve Wilson, FDA Regulatory Perspective – Data Integrity
  • FDA guidance on retention requirements for clinical trial data

And more

How it works

Either purchase the recorded seminar in an immediately available digital download format or request an invoice and the CD shipped to you within 10 business days.

Note: CD will be shipped after payment has been received. See our Better Business Bureau-accredited online purchasing and return policy for questions.

More benefits

  • Efficiency:  Elimination of travel means more affordable advice
  • Productivity:  Rely on technology tools to view the recorded seminar and get the reference materials
  • Veteran expertise:  Complement the seminar with a confidential teleconsulting session for further questions specific to your situation
  • Environmentally sound:  Spare our environment with less travel and a digital download

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