Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
This classroom course has been updated to include the new revised GAMP® 5 Second Edition.
Ensure control of critical environments within your facility and maintain GMP inspection readiness through improvements to your air, HVAC, and contamination controls. Topics include control system alarm management, common system construction deficiencies, GMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
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Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.