Validation of Manufacturing and Distribution Computer Systems
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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.
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