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ISPE DVC GAMP CoP "GAMP and ISA 95"
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About this event
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Date & Time
Wednesday,
June 11, 2025
5:00 PM - 8:00 PM
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Location
GSK
893 River Rd Conshohocken, PA 19428
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GAMP CoP "GAMP and ISA 95"
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Explore how ISA-95 can be used to reinforce GAMP® 5 principles by providing a foundation for categorizing system functions (Category 4/5), aligning user requirements with functional specifications, and enabling traceability across system lifecycle stages.
Case examples will illustrate how using ISA-95 models can enhance the clarity and completeness of GAMP documentation, support risk-based validation, and improve communication between stakeholders in IT, automation, and quality functions.
Attendees will gain practical insights into integrating these two complementary frameworks to streamline compliance and enable digital maturity in pharmaceutical manufacturing environments.
Moderator:
Dirk SweigartPMP, CISSP, Applied Control Engineering, Inc.
Presenter:
Chris Monchinski CTO, InflexionPoint LLC
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Category
Affiliate Group Event
Registration Info
Registration is required
Payment In Full In Advance Only