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21 CFR Part 11 Compliance For SaaS/Cloud Applications: 2-Day In-Person Seminar
Nov 04, 2018

21 CFR Part 11 Compliance for SaaS/Cloud Applications: 2-Day In-Person Seminar


Significant changes in the regulations and industry standards for software validation are detailed in this interactive 2-day course. The instructor will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records.


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.


Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Students learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.


Many companies are outsourcing IT resources and getting involved with Software as a Service and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. It will help attendees to understand the specific requirements associated with local and SaaS/cloud hosting solutions.





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