21 CFR Part 11 and Annex 11: What You Need to Know to Pass the New Regulatory Inspection

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This webinar demystifies Part 11 and the European equivalent Annex 11, and provides details for implementing computerized systems in local, SaaS, and cloud hosting environments. Learn exactly what is needed to be compliant for all three primary compliance areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

Course Objective

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). This training will be beneficial for anyone in Pharmaceutical, Medical Device, Biologics, Food, Cosmetics, FDA Regulated Companies, Software Vendors, SaaS.

Course Outline

  • Which data and systems are subject to the regulations
  • Requirements for local, SaaS, and cloud hosting 
  • What the regulations mean, not just what they say
  • Avoid 483 and Warning Letters
  • Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • Evaluate the regulatory requirements related to the current computer system standards for security, data transfer, audit trails, and electronic signatures
  • 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
  • Live Q&A

Target Audience

  • IT Personnel
  • QA Personnel
  • QC Managers
  • Laboratory staff
  • Managers/ Executives
  • GMP, GCP, GLP professionals
  • Auditors

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: David Nettleton,

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. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. 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.

Get in touch

(315) 632-0735,
(315) 750-4379