Special Note to PDA Members
: If you are a PDA member, please ensure that you use the PDA member discount code. If you don't have it, send an eMail to [email protected]
or Shanna Morgan
This webinar describes exactly what is required for compliance with 21 CFR Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. 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.
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 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 300 mission critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.