Description

Learn about the compliance requirements for 21 CFR Part 11, Annex 11, & SaaS, and current FDA thinking on electronic records and signatures.

Course Overview

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 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

Upon completion of this session, attendees will learn:

• 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

Areas Covered

• 1. What 21 CFR Part 11 means today
  • Purpose of Part 11

  2. What does Part 11 mean?

  • SOPs
  • System features
  • Infrastructure qualification
  • Validation

  3. Security standards

  • Roles
  • Usernames and passwords
  • Restrictions and logs

  4. Data transfer standards

  • Deleting data
  • Encryption

  5. Audit trail standards

  • Types of data
  • High-risk systems

  6. Electronic approval standards

  • Electronic signatures
  • Single sign-on
  • Replacing paper with electronic forms

  7. Infrastructure qualification

  • How to efficiently document qualifications

  8. Validation

  • Software validation for vendors
  • Computer system validation for users
  • Fill-in-the-blank templates
  • Change control re-validation

  9. SaaS/ Cloud Hosting

  • Responsibilities for the software vendor and hosting provider
  • Evaluation criteria
  • Hosting requirements

  10. SOPs

  • IT, QA, validation
  • Software development

  11. Annex 11

  • Comparison with Part 11

  12. EU GDPR

  • Data Privacy Statement

Who will benefit

This webinar is intended for professionals in the Medical Device, Biotechnology, and Pharmaceutical Industry. Personnel in the following roles will benefit:

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

About the Instructor

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. 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. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Refund policy

Attendees may cancel up to two working days prior to the course start date and the refund will be processed within two working days.

We will process/provide a refund if the webinar is canceled. Refunds will not be given to participants who do not show up for the webinar. On-demand Recordings can be requested in exchange. Webinar may be canceled due to lack of enrollment or unavoidable factors. Attendees will be notified 24 hours in advance if a cancellation occurs. Substitutions can happen at any time.

If you have any concerns about the content of the webinar and are not satisfied please contact us at care@thecomplyguide.com