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This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. What the regulation means 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/Areas Covered:
- Which data and systems are subject to Part 11 and Annex 11
- 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, and 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 will benefit/Target Audience:
- Computer system users
- Laboratory staff
- GMP, GCP, GLP professionals
- Software vendors
- Medical device
- FDA Regulated Companies
- Software Vendors
- SaaS providers
- Data centers
Upcoming Webinar by David:
June, 14, 2018 - Excel Spreadsheet Validation-Step by step guide to compliance
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 270 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.