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A Holistic Approach to External GMP Surveillance, GMP Training, and Quality Knowledge Management
Jerry Chapman
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FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS
Joy McElroy
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Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings
Rich Yeaton, Kelly Thomas
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Note to File 101: Critical Steps for When – And When Not To – Engage in NTFs
Luisa Monica, Jackie Morrill
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21 CFR Part 11: Understanding the ERES Regulation for Compliance Success
Judy Carmody
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ANDAs: FDA Guidance on Stability Testing of Generic Products
Kim Huynh-Ba
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Applying Quality Risk Management (QRM) in Manufacturing – A Proactive Approach
Danielle DeLucy
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Best Practices in CMC Dossier Preparation – Facing Tough Challenges
Albert Yehaskel
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CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
Sandra “SAM” Sather
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