Blog - Page 3 of 46 - Kenx Members

Developing a Site Preparation Strategy for a Successful FDA Inspection

Speaker Alan Golden, Principal, Design Quality Consultants To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.

GMP Laboratory Controls: Ensuring Data Integrity, Testing Accuracy, and Compliance

Speaker Vivekram Apparsundaram, Head of CQV – GxP Lab Systems Validation & Compliance, Zifo Technologies Inc.

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Building a Change Control Framework That Survives Inspection Scrutiny

Speaker Alan Golden, Principal, Design Quality Consultants

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Supplier Quality Management: Risk Mitigation Strategies That Work

Speaker Kim Huynh-Ba, M.S., FAAPS, Managing Director, Pharmalytik LLC

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Modernizing GMP Quality Systems: From Risk to Remediation in an Evolving FDA Landscape

Speaker Moderator: Gaurav Walia, VP of CSV/CSA/DI & Digital Governance, Head of Chicago PQE Office & Local Equity Partner, PQE Group Radia A. Wahab, Ph.D., Director Systems Integration & Engineering, Guardant Health Rebecca Fuller, Vice President, Regulatory Compliance, QualityHub Cindy Duhigg, Senior Principal, Global Manufacturing Science & Technology Engineering, Alcon

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