Graphic: PENSA Technology Solutions Inc.

Graphic: PENSA Technology Solutions Inc.
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Courses and Training

In addition to consulting and validation software, PENSA offers compliance training.

PENSA will provide validation training to ensure operators are qualified to perform assigned tasks which is a great process to satisfy FDA audits.

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Live Web Seminar - Complying with 21CFR Part 11-Understanding the Role of Predicate Rules - 29-Aug-2006 - Click here for more information

 

 

The following validation courses are offered by PENSA either in house or at a specified location:

  • Validation Basics
    This training unit provides the fundamentals required to understand the methodology used to validate a computer-related system. The concepts introduced in this unit provide the framework for subsequent training that identifies the specified steps required to complete the validation of a computer-related system.
     
  • Detailed Validation Methodology
    This training unit provides the details required to understand the methodology used to validate a computer-related system. The details of the methodology discussed in this unit build on the concepts introduced during previous Validation Basics training regarding validation of a computer-related system.
     
  • Complete Validation
    A combination of the 2 courses listed above.
     
  • Vendor Audit
    This training unit provides details required to understand how to perform a Vendor Audit on a supplier of software or hardware. The information provided in this unit can be used to assist in performing a vendor audit. Finally, it will provide some sample questions that can be used during the audit.
     
  • Change Management
    This training unit provides the fundamentals required to understand the Change Management of a validated computer-related system. The information introduced in this unit provide the detail procedure as well as specific examples to illustrate the steps required to maintain the validated state of a computer-related system through Change Management.
     
  • Electronic Signatures and Records
    This training unit provides the fundamentals required to understand the regulations identified in 21 CFR Part 11 for Electronic Records and Electronic Signatures. The information introduced in this unit allows the participant to form an interpretation of 21 CFR Part 11 and validate a computer related system against the necessary requirements.

PENSA has a business partnership with JD Edwards, providers of OneWorld ERP systems. To date we have validated more than 20 installations of OneWorld. Because of this knowledge and experience we can adjust any of these courses to a OneWorld user perspective which can give you the knowledge to do the validation yourselves. PENSA can follow up with an audit to review if you so wish.

To request more detailed information, please e-mail Sales@GMPs.com.

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