The Compliance Crackdown: Guarding Against FDA Action

The Compliance Crackdown: Guarding Against FDA Action

Experts from PRISYM ID Explore What Is Required For FDA 21 CFR Part 11 Compliance And How Best To Achieve It

The FDA is cracking down when it comes to FDA 21 CFR Part 11 compliance. The last few years have shown an increase in the number of inspections, seizures, injunctions, Warning Letters, and recall events; and penalties are being enforced to discourage future offenses.

In addition, companies need to be faster than ever to respond to any action taken by the FDA. Less leniency is being given for the 15-day period to respond to an FDA Warning Letter and an FDA injunction can now be issued prior to even sending a Warning Letter.

What is the best way to survive an FDA inspection? Make sure you are compliant! Watch-back our complimentary Webinar, ‘The Compliance Crackdown: Guarding Against FDA Action’, for tips on how to ensure your label design, approval, management and production processes are secure. In this 60 minute, information-packed session, experts from PRISYM ID explore what is required for compliance and how to achieve it.

Benefits of viewing:

  • Learn what it means to be FDA 21 CFR Part 11 compliant
  • Gain awareness of the most common compliance pitfalls and how to avoid them
  • Discover how software can aid your business when designing, producing and managing labels
  • Understand how costs can be significantly reduced while gaining and maintaining strict compliance global regulations and standards

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