Compliance Training on 21 CFR Part 11

At Ofni Systems, not only do we provide the highest quality compliance services, but we can also train your employees to be proactive in dealing with compliance issues. Training can be provided either on-site or at designated training centers. All attendees will receive a Certificate of Training in 21 CFR Part 11, good for satisfying GxP training requirements.

Ofni Systems has presented informational and training sessions on numerous topics, including Preparing for FDA CSV Inspections, Automating CSV Processes, and 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets. Ofni Systems can create or customize any training program to meet your exact needs. We can provide any level of service, from teaching a single course to creating and managing your training department.

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Online Training Courses

Introduction to 21 CFR 11

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)

On-Site Compliance Training Course

Computer System Validation
Ensure your compliance with 21 CFR 11.10(a). This course teaches you how to validate all of your computer systems. Attendees will learn how to gather system requirements; transform requirements into user requirements, functional specifications, and design specifications; create appropriate testing protocols; and how to maintain validated systems. Training includes case studies and best practices for specific computer systems. (1-day, 2-day, 3-day, and 1-week curricula available).

Access Databases and Part 11 Compliance

Transform any Access Database into an electronic record system with full Part 11 compliance. The 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 Access programs, including best practices and risk assessment strategies to help determine the scope of the validation. (2-day curriculum; can be expanded, upon request, to increase number of databases )

Assessing Compliance with 21 CFR Part 11

Assess your compliance with 21 CFR Part 11, Electronic Record and Electronic Signature systems. The course teaches you to examine your systems for compliance with 21 CFR 11 and to create appropriate Corrective Action Plans. Attendees will learn how to create a list of systems to evaluate, assign priorities for each system, designate responsibilities to appropriate staff, perform gap analysis against the actual text of 21 CFR 11, and determine appropriate corrective actions for any gaps found during the assessment. Most companies find that their compliance assessment can be completed during the training session itself. (1-day curriculum; can be expanded, upon request, to increase number of assessments completed)

Custom Training Materials

Ofni Systems can create training materials and on-line help files for all of your software, databases, or computer systems.

Benefits of Using Ofni Systems for Compliance Training

• Experience with FDA and GxP requirements – Ofni Systems professionals are experts at compliance issues with years of real-world experience. Let our experience provide your employees with a firm foundation for dealing with 21 CFR Part 11.
• Improved Value to Your Quality Systems – Expect short-term gains of 10–25% simply by educating your workforce about Part 11 requirements.