What exactly is required for 21 CFR Part 11, SaaS/Cloud, EU GDPR


David Nettleton is a keynote speaker of ComplianceKey. Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications. He has completed more than 280 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Soft........

Overview

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

Why should you attend this webinar?

Our Speaker David Nettleton will explain:Which data and systems are subject to Part 11 and Annex 11

Areas Covered in the Session:

Who can Benefit:

Industries:
  • Pharmaceutical
  • Medical device
  • Biologic
  • Food
  • Cosmetics
  • FDA Regulated Companies
  • Software Vendors
  • SaaS providers
  • Data centers



Webinar Id: LHSCDN001

Training Options:

Duration: 60 mins

 Stop, pause, and rewind: learn at your own place.

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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