Compliance Training
Compliance Training Systems, not only do we give the loftiest quality compliance services, but we can also train your workers to be visionary in dealing with compliance issues. Training can be handed moreover on- point or at designated training centers. All attendees will admit a Certificate of Training in Compliance Training 21 CFR Part 11, good for satisfying GxP training conditions.
Ofni Systems has presented instructional and training sessions on multitudinous motifs, including Preparing for FDA CSV Examinations, Automating CSV Processes, Compliance Training and Compliance Training 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets. Ofni Systems can produce or customize any training program to meet your exact requirements. We can give any position of Compliance Training service, from tutoring a single course to creating and managing your training department.
Online Training Courses
Preface to 21 CFR 11
Educate your help to the conditions of Compliance Training 21 CFR 11, Electronic Records Electronic Autographs. This course reviews the textbook and common interpretation of Compliance Training 21 CFR 11, including technological and procedural controls needed for systems to be biddable with the regulation. The course includes a 30- nanosecond Q&A, with a compliance expert answering any specific questions your association may have relating to compliance with 21 CFR 11. (2 hours)
Part 11 Compliance for MS Excel Spreadsheets
Make your MS Excel spreadsheets biddable with 21 CFR 11. This course starts with a full, in- depth review of the specialized and procedural conditions of 21 CFR Part 11, along with interpretations of how the conditions are applied. All attendees will admit training on stylish practices in validating MS Excel spreadsheets, including threat assessment strategies to help determine the compass of the confirmation. The course includes a 30- nanosecond Q&A, with a compliance expert answering any specific questions about spreadsheet compliance. This course also includes a free trial dupe of ExcelSafe. (2 hours)
Review of Computer System Validation Documentation and Ways
Review the conditions for Computer System confirmation, 21 CFR11.10 (a). This course reviews the conditions for computer confirmation, including the assiduity- accepted collection of attestation which constitutes a confirmation package. Attendees will bandy stoner conditions, Compliance Training functional specifications and design specifications, demand traceability, threat assessment, creating applicable testing protocols, summary reports, and how to maintain your validated systems. Training includes case studies and stylish practices for specific computer systems. The course includes a 30- nanosecond Q&A, with a confirmation expert answering any specific questions your association may have relating to computer confirmation. (3 hours)
On- Point Compliance Training Course
Computer System Confirmation
Insure your compliance with Compliance Training 21 CFR11.10 (a). This course teaches you how to validate all of your computer systems. Attendees will learn how to gather system conditions; transfigure conditions into stoner conditions, functional specifications, and design specifications; produce applicable testing protocols; and how to maintain validated systems. Training includes case studies and stylish practices for specific computer systems. (1- day, 2- day, 3- day, and 1-week classes available).
Access Databases and Part 11 Compliance
Transfigure any Access Database into an electronic record system with full Part 11 compliance. The course starts with a full, in- depth review of the specialized and procedural conditions of 21 CFR Part 11, along with interpretations of how the conditions are applied. All attendees will admit training on stylish practices in validating Access programs, including stylish practices and threat assessment strategies to help determine the compass of the confirmation. (2- day class; 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 Hand systems. The course teaches you to examine your systems for compliance with 21 CFR 11 and to produce applicable Corrective Action Plans. Attendees will learn how to produce a list of systems to estimate, assign precedences for each system, designate liabilities to applicable staff, perform gap analysis against the factual textbook of 21 CFR 11, and determine applicable corrective conduct for any gaps plant during the assessment. Utmost companies find that their compliance assessment can be completed during the training session itself. (1- day class; can be expanded, upon request, to increase number of assessments completed).
Custom Training Accoutrements
Ofni Systems can produce training accoutrements and on- line help lines for all of your software, databases, or computer systems.
Benefits of Using Ofni Systems for Compliance Training
Experience with FDA and GxP conditions – Ofni Systems professionals are experts at compliance issues with times of real- world experience. Let our experience give your workers with a firm foundation for dealing with 21 CFR Part 11.
Advanced Value to Your Quality Systems – Anticipate short- term earnings of 10 – 25 simply by educating your pool about Part 11 conditions.