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Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
Separate registration required.
To learn more and register, follow this link: https://ispe.org/training/course/commissioning-qualification
Speaker(s):
Lisa
J. Graham,
PhD, PE,
Chief Executive Officer,
Seeq Corporation
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