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.
Duration: 75 Minutes
Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment
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.