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:
- Which data and systems are subject to Part 11 and Annex 11
- How to write a Data Privacy Statement
- What the regulations mean, not just what they say
- Avoid 483 and Warning Letters
- Requirements for local, SaaS, and cloud hosting
Agenda:
- What 21 CFR Part 11 means today
- Purpose of Part 11
- SOPs
- System features
- Infrastructure qualification
- Validation
- Roles
- Usernames and passwords
- Restrictions and logs
Who Will Benefit:
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers
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