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

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.

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

Who Should Attend:-

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

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.

After Registration:
Once you register, you’ll receive a confirmation email with your login credentials and access to downloadable presentation materials. These resources can also be shared with your team for internal training and reference.

System Requirements:
Internet: A stable internet connection of at least 1 MBPS is recommended for a smooth experience.
Audio: Use a working headset or speaker with a microphone for clear audio, especially during interactive sessions.

Session Cancellation Policy:
If a session must be cancelled or rescheduled, WebinarWaves will notify all registered participants via email no later than 24 hours before the scheduled start time.

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What Attendees Are Saying:
I really enjoyed this webinar! The content was spot-on for anyone handling

medical affairs. The examples shared made it easy to follow, and I walked away

with actionable tips I can use right away. Good Job Webinar Waves. - Robert Johnson, Medical Affairs Manager

Clear and informative session. Everything about compliance and regulations

was explained in a way that actually makes sense. - Mei Lin, Regulatory Affairs Specialist

Valuable webinar! Provided valuable insight into how logistics risks are defined,

managed, and communicated within the pharmaceutical sector - Michael Torres, Supply Chain Manager