21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
Instructor:
David Nettleton
Product ID: 704533
- Duration: 60 Min
Why Should You Attend:
This webinar will describe exactly what is required for compliance with Part 11 and the updated European equivalent Annex 11. It will take the concepts described in the regulations and expand them into specifics for all three primary compliance areas: SOPs, product features, and validation. Attendees will learn what is required for IT, SaaS, and cloud hosting. All required IT SOPs will be described. Product features based on the current industry standards will be explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.
Areas Covered in the Webinar:
- Which data and systems are subject to Part 11 and Annex 11
- What the regulations mean, not just what they say
- Avoid 483s and Warning Letters
- Explore the three primary areas of compliance: SOPs, software product features, and validation documentation
- Learn the requirements for IT, SaaS, and cloud hosting
- 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
- 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
Who Will Benefit:
- Computer system users
- IT personnel
- QA personnel
- Managers
- Executives
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. His wide knowledge on these subjects comes from his involvement in the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications.
He has completed more than 230 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.
More Training By Experts
- GAMP® Validation Protocols for Efficient Documentation
- Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
- 10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
- Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
- Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Refund Policy
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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).
