Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Why Should You Attend:

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and 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
• What the regulations mean, not just what they say
• Avoid 483s and Warning Letters
• Explore the three primary areas of compliance: SOPs, software product features, and validation documentation
• Learn the requirements for IT, SaaS, and cloud hosting
• Ensure data integrity, security, and protect intellectual property
• Understand the current computer system industry standards for security, data transfer, and audit trails
• Electronic signatures, digital pens, and biometric signatures
• SOPs required for the IT infrastructure
• Product features to look for when purchasing COTS software
• Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Who Will Benefit:

• Computer system users
• IT personnel
• QA personnel
• Managers
• Executives