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


Instructor: David Nettleton
Product ID: 701687

  • 6
  • August 2024
  • 10:00 AM PT | 01:00 PM ET
    Duration: 90 Min
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).

August 06, Tuesday 10:00 AM PT | 01:00 PM ET
Duration: 90 Min


One Dial-in One Attendee

Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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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 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..

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


  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
  9. SaaS/Cloud hosting
    • Responsibilities for 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

Frequently Asked Questions:

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

Who Will Benefit:

  • GMP, GCP, GLP, regulatory professionals
  • QA/QC
  • IT
  • Auditors
  • Managers and directors
  • Software vendors, hosting providers
Instructor Profile:
David Nettleton

David Nettleton
FDA Compliance Specialist, ComputerSystemValidation

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 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 250 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.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. 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 cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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