Ofni -Â Online Compliance Training Courses
Educate your personnel to the requirements of 21 CFR 11, Electronic Records: Electronic Signatures. This course reviews the text and common interpretation of 21 CFR 11, including technological and procedural controls required for systems to be compliant with the regulation. The course includes a 30-minute Q&A, with a compliance expert answering any specific questions your organization may have relating to compliance with 21 CFR 11. (2 hours).
Part 11 Compliance for MS Excel Spreadsheets
Make your MS Excel spreadsheets compliant with 21 CFR 11. This course starts with a full, in-depth review of the technical and procedural requirements of 21 CFR Part 11, along with interpretations of how the requirements are applied. All attendees will receive training on best practices in validating MS Excel spreadsheets, including risk assessment strategies to help determine the scope of the validation. The course includes a 30-minute Q&A, with a compliance expert answering any specific questions about spreadsheet compliance. This course also includes a free trial copy of ExcelSafe. (2 hours)
Review of Computer System Validation Documentation and Techniques
Review the requirements for Computer System validation, 21 CFR 11.10(a). This course reviews the requirements for computer validation, including the industry-accepted collection of documentation which constitutes a validation package. Attendees will discuss user requirements, functional specifications and design specifications, requirement traceability, risk assessment, creating appropriate testing protocols, summary reports, and how to maintain your validated systems. Training includes case studies and best practices for specific computer systems. The course includes a 30-minute Q&A, with a validation expert answering any specific questions your organization may have relating to computer validation. (3 hours)