The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

Instructor: David Nettleton
Product ID: 704734
  • Duration: 60 Min
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This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.

Why Should You Attend:

This webinar will describe exactly what is required for compliance with Part 11 and Annex 11 for local, and SaaS/Cloud hosted applications. What the regulation means is described for all four primary compliance areas: SOPs, product features, infrastructure qualification, and validation. All required IT and QA SOPs are described.

Product features based on the current industry standards are explained in detail. Learn how to qualify infrastructure and virtual environments. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.

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 483 and Warning Letters
  • Explore the four primary areas of compliance: SOPs, software product features, infrastructure qualification, and validation documentation
  • Learn the requirements for IT, SaaS, and cloud hosting
  • How to use electronic signatures, and ensure data integrity, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation time and documentation by using easy to understand fill-in-the-blank validation documents

Who Will Benefit:

  • IT
  • QA and QC
  • Managers
  • Software vendors
  • All computer system users

Instructor Profile:

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 260 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.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

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