Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Description
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 the 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.
Learning Objectives
- 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
- Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
- How to use electronic signatures, ensure data integrity, and protect intellectual property
- 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 Should Attend
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers
Webinar Details
Speaker
David Nettleton
Industry
Healthcare
Speciality
Pharmaceuticals
Duration
90 Minutes
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David Nettleton
(speaker)
Computer System Validation’s principal, David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with developing, purchasing, installing, operating, and maintaining computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.