Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and 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.
- Which data and systems are subject to Part 11 and Annex 11
- How to write a Data Privacy Statement
- What the regulations mean, not just what they say
- Avoid 483 and Warning Letters
- Requirements for local, SaaS, and cloud hosting
- Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
- How to use electronic signatures, ensure data integrity, and protect intellectual property
- SOPs required for the IT infrastructure
- Product features to look for when purchasing COTS software
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
- GMP, GCP, GLP, Regulatory Professionals
- QA/QC
- IT
- Auditors
- Managers and Directors
- Software vendors, Hosting Providers
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU 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 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.
Upcoming Webinars
By Bruce Lee
Date: Nov. 21, 2024
By William Mack Copeland
Date: Nov. 22, 2024
By Dr. Susan Strauss
Date: Nov. 25, 2024
By Carolyn Troiano
Date: Nov. 25, 2024
By Charles H. Paul
Date: Nov. 25, 2024
By Gary Heppner
Date: Nov. 26, 2024
By Yedid Chavez
Date: Nov. 26, 2024
By Justin Muscolino
Date: Nov. 26, 2024
By Michael Healey
Date: Nov. 27, 2024
By Kelly Thomas
Date: Dec. 2, 2024
By Mark Gorkin
Date: Dec. 2, 2024
By Paul J. Cline
Date: Dec. 3, 2024
By William J. Rothwell
Date: Dec. 3, 2024
By Marcia Zidle
Date: Dec. 3, 2024
By Pete Tosh
Date: Dec. 4, 2024
By Gary Heppner
Date: Dec. 4, 2024
By Don Phin
Date: Dec. 5, 2024
By William Mack Copeland
Date: Dec. 5, 2024
By Edwin Waldbusser
Date: Dec. 6, 2024
By Ginette M. Collazo
Date: Dec. 13, 2024
By Cathy Horwitz
Date: Dec. 20, 2024
By Margie Faulk
Recorded Session
By Miles Hutchinson
Recorded Session
By Deborah Covin Wilson
Recorded Session
By Donna K Olheiser
Recorded Session
By Catherine M. Mattice
Recorded Session
By Neil Malek
Recorded Session
By Deborah Covin Wilson
Recorded Session
By Ray Graber
Recorded Session
By Janette Levey Frisch
Recorded Session
By Paul J. Sanchez
Recorded Session
By Catherine M. Mattice
Recorded Session
By Danielle DeLucy
Recorded Session
By Lisa Marsden
Recorded Session
By E. Pete Lewis
Recorded Session
By Mike Thomas
Recorded Session
By Deborah Covin Wilson
Recorded Session
By Jeff Kasoff
Recorded Session
By Candace Curry Leuck
Recorded Session
By Loren Gelber
Recorded Session
By Rebecca Staton-Reinstein
Recorded Session
By Marcia Zidle
Recorded Session
By Paul R Hales
Recorded Session
By Paul J. Sanchez
Recorded Session
By Margie Faulk
Recorded Session
By Deborah Covin Wilson
Recorded Session
By Lisa Marsden
Recorded Session
By Michael D Haberman
Recorded Session
By Mike Thomas
Recorded Session
