Two Day 21 CFR Part 11 Compliance for SaaS/Cloud Applications Seminar (Scottsdale, AZ, United States - January 31st, 2018 February 1, 2018)

This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.

This course is intended for these regulated companies, software vendors, and SaaS/cloud providers.

The seminar instructor will:

Learning Objectives:

Who Should Attend:

For more information about this conference visit https://www.researchandmarkets.com/research/xnzfzg/21_cfr_part_11

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

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