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 steps 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 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 before 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 and 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 before being required to have validation reports?

Why Should You Attend:-

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with 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