TMCnet News
Two Day 21 CFR Part 11 Compliance for SaaS/Cloud Applications Course (San Diego, CA, United States - June 15-16, 2017) - Research and MarketsDUBLIN, April 07, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "21 CFR Part 11 Compliance for SaaS/Cloud Applications: 2-day In-person Seminar" conference to their offering. 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 valiation to avoid FDA form 483s and Warning Letters. This course is intended for these regulated companies, software vendors, and SaaS/cloud providers. - Address the latest computer system industry standards for data security,data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Learning Objective: - Understand what is expected in Part 11 and Annex 11 inspections For more information about this conference visit http://www.researchandmarkets.com/research/tqsbwq/21_cfr_part_11 Media Contact: Laura Wood, Senior Manager
|