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Webinar: 21 CFR Part 11: 20 Years Later

April 18 @ 2:00 pm - 3:00 pm EDT

Join us Wednesday, April 18th, 2018 at 2:00pm EDT

"In August of 1997, the FDA released 21 CFR part 11 to the industry. The regulation was met with confusion as to exactly what it meant, who was responsible for the compliance (vendors or end users), and how to make every computer system compliant. The FDA then released guidance documents, the industry grasped on to legacy systems, and software developers started incorporating part 11 compliance functionality. And then came the Scope and Guidance in 2003 and there was light at the end of the tunnel.

Fast forward to today; where we have come since the beginning? How has technology changed? Do we know what it all means, or are there still questions to ask? And now with cloud systems, virtual employees, and everything going digital, do we know who is responsible for all those records? Are we any closer to compliance than we were in 1997? Join us for this one hour webinar as we answer these questions and more."

Key Takeaways:

  • Understand where part 11 has taken the industry
  • Learn how technology has adapted to regulations
  • Discover different approaches for how companies have complied with the regulation
  • See how you can leverage experience and industry knowledge to be compliant

 

Who Should Attend?

  • Laboratory Directors, Managers and Analysts
  • IT Executives and Leaders
  • Quality Control and Quality Assurance
  • Plant Management & Manufacturers

You will have the opportunity to speak directly with a Computer System Validation expert and receive real-time answers.

 

This is a complimentary hour long presentation including a Q & A portion.

Wednesday, April 18, 2018 at 2:00pm EDT

CSols, Inc. reserves the right to grant or deny access to its webinars, literature, and other materials at its sole discretion.

Details

Date:
April 18
Time:
2:00 pm - 3:00 pm
Event Category:
Website:
http://www.csolsinc.com/news/events/webinars/this-months-lab-informatics-webinar/