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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).
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:
Who Will Benefit:
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.
Contact for Registration: