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Course ID:
1526

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Validation of Manufacturing and Distribution Computer Systems
November 03 - 05, 2008
New Brunswick, NJ

Online Registration is not available at this time. Click on the Notify Me button to the left to be notified when online registration is available.

This course is available as a client site course. Please click here for more information.

Who Should Attend
This course is a must for both users and developers of FDA regulated systems who want and need to know what the FDA expects and requires, what computer validation is, and what needs to be done to validate a computer-based system. It will benefit:

  • Users of Systems
  • Project Managers
  • Information System Professionals
  • Regulatory Affairs Staff
  • Quality Assurance and Control Personnel
  • System Developers and Integrators
  • Vendors
This course is very important for those in the pharmaceutical, biologics, software and related industries because of the FDA’s increasing emphasis on computer systems, electronic signatures and records, and the extensive use of ERP and MRP systems.

Description
This course is designed to provide an overview of the various aspects of computer validation and to provide the basis for compliance and implementation. The course addresses the rules, tools, and techniques to develop and implement a validation process or to validate a single system. It provides the basic concepts for validation and offers a framework and the technologies to conduct validation projects.

The emphasis is on the most recent rules and techniques including the relevant CFRs, QSIT, the system life cycle including prototyping, testing, qualifications, electronic signatures and records, data and system security and integrity, vendor management and assessment source code, acquired and developed systems, “shrink wrapped” systems, networks, validation, master plan, the validation project, risk assessment, the QSRs, electronic submissions, SOPs, recall requirements for computer-controlled inventories, network validation, requirements documentation, the trace matrix, mainframes, servers, desktop computers, ERP and MRP packages.

You will have an opportunity to ask specific questions, identify goals for the class and participate in several class exercises to develop a validation SOP, develop a plan for electronic signatures and records, and test protocols.

Also discussed are current trends in the industry, the problems of new technologies and FDA-specific issues, findings and directions. The work book provides regulations, sample SOPs, validation tools and FDA reference documentation and material.

Other Courses of Interest

cGMP for Pharmaceutical Production Supervisors

IQ, OQ, PQ
Jun 17 2008
, New Brunswick, NJ

IQ, OQ, PQ
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System Validation, GAMP Harmonization and P.A.T

Validation Workshop for Computer Systems


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