SaaS/Cloud Risk-Based Validation With Time-Saving Templates

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.

Who Will Benefit:

• GMP, GCP, GLP, regulatory professionals
• QA/QC
• IT
• Auditors
• Managers and directors
• Software vendors, hosting providers