Validation of Manufacturing and Distribution Computer Systems
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Who Should Attend
This course will be of particular value to individuals
responsible for
- System Quality Control
- System Management and Development
- Computer System Validation
Description
Recent problems associated with computer inaccuracies have
led the FDA to pressure the pharmaceutical and blood
processing industries into adoption of rigid standards of
system validation and testing. The application of a testing
methodology is of particular importance in design, operation
and quality control of manufacturing systems, where
computers are integrally used in product control and inventory
tracking.
This course is designed to provide the necessary skills for
mastering the principles and techniques of developing and
implementing a system validation and testing plan for
manufacturing-related computer systems. The course uses a
combination of lecture/discussions, case studies, “role-play
actors,” and multimedia presentations to provide a living case
of a computerized pharmaceutical system in need of a
validation plan for cGMP information systems. The program
will take participants step-by-step through the process of
developing and implementing that plan, and will conclude with
a session adapting the plan to each participant’s unique
environment and products.
Features of the Course Include:
- Specification of a methodology for meeting FDA and PMA
guidelines for manufacturing systems involving computers
- Practical experience in applying that methodology to actual
computerized manufacturing systems
- New update on 21 CFR Part 11
Other Courses of Interest
Applied cGMPs for Pharmaceutical and Allied Industries
Best Practices in SAS Statistical Programming for Regulatory Submission
Conducting Effective Quality Audits
cGMP for Pharmaceutical Production Supervisors
Documentation Management and Control
Mar 05 2012, New Brunswick, NJ
Documentation Management and Control
Jun 07 2012, Amsterdam, The Netherlands
ICH Q10: Pharmaceutical Quality System
IQ, OQ, PQ
Mar 13 2012, New Brunswick, NJ
IQ, OQ, PQ
May 14 2012, Amsterdam, The Netherlands
System Validation, GAMP Harmonization and P.A.T
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