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

David Nettleton
From: Oct 26, 2023 - To: Dec 31, 2023
Recorded Webinar
  

Description

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features, and validation (10-step risk-based approach).

Areas Covered in the Webinar:-

  • 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

Agenda:-

  • What 21 CFR Part 11 means 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 hosting provider
    • Evaluation criteria
    • Hosting Requirements
  • SOPs
    • IT, QA, validation
    • Software development
  • Annex 11
    • Comparison with Part 11
  • EU GDPR
    • Data Privacy Statement

Frequently Asked Questions:-

  • How do you suggest communicating to the vendor the importance of all versions (even minor) being validated prior to implementation?
  • All log-ins and log-outs must be visible in the audit log. even log outs due to inactivity?
  • Does Single Sign On (SSO) capability go against the "passwords are not remembered" rule?
  • For the new Data Privacy role will that be a QA or IT position?
  • What exactly is the validation that needs to occur each time my vendor deploys a minor or major release?
  • How can we get access to infrastructure qualification templates?
  • You talked about data retention, so is the data supposed to be deleted or archived from a compliance perspective?
  • Do you have any advice for validating software systems that were in place for many years prior to being required to have validation reports?

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 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.

Who Will Benefit:-

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

Training Options

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Recording
   $179  

Transcript (Pdf)
   $179  

DVD
   $189  

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