Kelly Menze, Senior Global Supplier Quality Engineer, Creation Technologies; Andrea Roether, Senior Director of Global Quality, Creation Technologies To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.
Ravi Nabar, Senior Vice President, Quality and Regulatory Compliance, Compliance Group; Steve Silverman, President, The Silverman Group
Presented by: Dave DeLuca, Lakshmi Chitrapu, and Ken ShitamotoThis webinar covers the following topics:Recognizing the interconnectedness of GxP and non-GxP regulations is key to developing a comprehensive compliance strategy. Integration allows organizations to streamline processes, reduce redundancies, and ensure consistency across regulatory requirements. Achieving synergy between GxP and non-GxP regulations enhances operational efficiency, mitigates risks, […]
Presented by: Dr. José C. Menezes, CSO, ValGenesisJoin us for a webinar where we’ll delve into the practical application of ICH Q12 principles for biopharma operations. Biotech processes prior to QbD use control strategies that lack understanding of criticality and definition of CPPs or CQAs. Discover how to define these parameters from manufacturing history, and […]
Created by: Kimberly Wallbank & Nicole DamourProduct complaints and reports of adverse events are unwelcome events at any company, especially if a product recall must be considered. However, these must be handled promptly and with all due diligence to prevent authentic drug- related events from negatively impacting the health and well-being of patients. This article […]
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