Compliance Coaching On Twenty One CFR Half Eleven:

At Ofni Systems, not solely will we give the best quality compliance Half eleven  services, however we will conjointly train your staff to be proactive in addressing compliance problems. coaching may be provided either on-site or at selected coaching centers. All attendees can receive a Certificate of coaching in 21 CFR Part 11, smart for satisfying GxP coaching necessities.

Ofni Systems has given informational and coaching sessions on varied topics, together with getting ready for FDA CSV Inspections, Automating CSV Processes, and twenty one CFR half eleven Compliance and Validation for Databases and Spreadsheets. Ofni Systems will produce or customise any educational program to fulfill your actual desires. we will give any level of service, from teaching one course to making and managing your coaching department.

Online Coaching Courses

Educate your personnel to the necessities of twenty one CFR eleven, Electronic Records: Electronic Signatures. This course reviews the text and customary interpretation of twenty one CFR eleven, together with technological and procedural controls needed for systems to be compliant with the regulation. The course includes a 30-minute Q&A, with a compliance skilled respondent any specific queries your organization might have concerning compliance with twenty one CFR eleven.

Part Eleven Compliance For MS Surpass Spreadsheets

Make your MS surpass spreadsheets compliant with twenty one CFR eleven. This course starts with a full, in-depth review of the technical and procedural necessities of twenty one CFR half eleven, together with interpretations of however the necessities area unit applied. All attendees can receive coaching on best practices in corroboratory MS surpass spreadsheets, together with risk assessment ways to assist verify the scope of the validation. The course includes a 30-minute Q&A, with a compliance skilled respondent any specific questions about programme compliance. This course conjointly includes a free trial copy of ExcelSafe. (2 hours)

Review Of Automatic Data Processing System Validation Documentation And Techniques

Review the necessities for automatic data processing system validation, 21 CFR 11.10(a). This course reviews the necessities for pc validation, together with the industry-accepted assortment of documentation that constitutes a validation package. Attendees can discuss user necessities, useful specifications and style specifications, demand traceability, risk assessment, making applicable testing protocols, outline reports, and the way to keep up your valid systems. coaching includes case studies and best practices for specific pc systems. The course includes a 30-minute Q&A, with a validation skilled respondent any specific queries your organization might have concerning pc validation.

On-Site Compliance Coaching Course

Ensure your compliance with twenty one CFR eleven.10(a). This course teaches you the way to validate all of your pc systems. Attendees can find out how to assemble system necessities; remodel necessities into user requirements, useful specifications, and style specifications; produce applicable testing protocols; and the way to keep up valid systems. coaching includes case studies and best practices for specific pc systems. (1-day, 2-day, 3-day, and 1-week curricula available).

Access Databases And Half Eleven Compliance

Transform associate degreey Access info into an electronic record system with full half eleven compliance. The course starts with a full, in-depth review of the technical and procedural necessities of twenty one CFR half eleven, together with interpretations of however the necessities area unit applied. All attendees can receive coaching on best practices in corroboratory Access programs, together with best practices and risk assessment ways to assist verify the scope of the validation. (2-day curriculum; may be expanded , upon request, to extend variety of databases )

Assessing Compliance With Twenty One CFR Half Eleven

Assess your compliance with twenty one CFR half eleven, Electronic Record and Electronic Signature systems. The course teaches you to look at your systems for compliance with twenty one CFR eleven and to make applicable Corrective Action Plans. Attendees can find out how to make a listing of systems to judge, assign priorities for every system, designate responsibilities to applicable employees, perform gap analysis against the particular text of twenty one CFR eleven.

Verify applicable corrective actions for any gaps found throughout the assessment. Most firms realize that their compliance assessment may be completed throughout the coaching session itself. (1-day curriculum; may be expanded , upon request, to extend variety of assessments completed)

Custom Coaching Materials

Ofni Systems will produce coaching materials and on-line facilitate files for all of your computer code, databases, or pc systems.

Benefits Of  Victimisation Ofni Systems For Compliance Coaching

Experience with FDA and GxP necessities – Ofni Systems professionals area unit consultants at compliance problems with years of real-world expertise. Let our expertise give your staff with a firm foundation for addressing twenty one CFR half eleven.
Improved worth to Your Quality Systems – Expect short gains of 10–25% just by educating your men concerning half eleven necessities.