This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
Why Should You Attend:
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, 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.
Areas Covered in the Webinar:
1.What 21 CFR Part 11 means today
2.What does Part 11 mean?
4.Data transfer standards
5.Audit trail standards
6.Electronic approval standards
Who Will Benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session