21 CFR Part 11 and Annex 11 Compliance; Specifics Needed to Eliminate 483s When Using SaaS/Cloud


 Available : All Days  Presented By : David Nettleton
 Category : Pharmaceutical  Event Type : Recorded Webinar

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Recording $199
Transcript $199
DVD $209
Flash Drive $229
Recording & Transcript $369

Description

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent, Annex 1,1 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?
  • Impact of Electronic Systems…Clinical Investigations Q&A Guidance for Industry Oct 2024
  • What do 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 do you 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
  • How to write a Data Privacy Statement?

Areas Covered:-

  • What does 21 CFR Part 11 mean today?
    • Purpose of Part 11
  • What does Part 11 mean?
    • SOPs
    • System features
    • Infrastructure qualification
    • Validation
  • Security standards
    • Roles
    • Usernames and passwords
    • Restrictions and logs
  • Data transfer standards
    • Deleting data
    • Encryption
  • Audit trail standards
    • Types of data
    • High-risk systems
  • Electronic approval standards
    • Electronic signatures
    • Single sign-on
    • Replacing paper with electronic forms
  • Infrastructure qualification
    • How to efficiently document qualifications?
  • Validation
    • Software validation for vendors
    • Computer system validation for users
    • Fill-in-the-blank templates
    • Change control re-validation
  • SaaS/Cloud hosting
    • Responsibilities for the software vendor and the hosting provider
    • Evaluation criteria
    • Hosting requirements
  • SOPs
    • IT, QA, validation
    • Software development
  • Annex 11
    • Comparison with Part 11
  • EU GDPR
    • Data Privacy Statement   

Who Should Attend:-

  • GMP, GCP, GLP, regulatory professional
  • QA/QC
  • IT
  • Auditors
  • Managers and directors
  • Software vendors, hosting providers.

Presented By : David Nettleton

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.

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