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Quality Management System (QMS) Inspection Readiness – Five Best Tips

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Pharmaceutical Management System (PQS) is the cornerstone of pharmaceutical development and commercialization, and quality inspection will identify the weakness of the organization.  This session will introduce the PQS and five best tips to help the organization ready for a quality system inspection.  The following topics will be discussed:

  • Structure of the Quality Systems as per ICH Q10
  • The role of Quality Management and the audit program
  • Critical factors that will effect quality inspections
  • Quality programs to support inspections
  • Maintain compliance and efficiency throughout the product lifecycle

 

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Speakers

Kim Huynh-Ba

Managing Director, Pharmalytik

Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has almost 30-years of experience in the Quality System environment, strategic drug development and stability sciences. She is a Council of Expert of US Pharmacopeia (2015-2020), where she chairs the Chemical Medicines IV Expert Committee. She is also a member of the USP Organic Impurities of Drug Products Expert Panel as well as the former chair of the USP Good Documentation Practices Expert panel. Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology where she teaches Quality Audits, GMPs, ICH Quality Guidelines and Pharmaceutical Analysis. She is the editor of the two well-known stability handbooks; “Handbook of Stability Testing of Pharmaceutical Products” and “Stability Testing to Support Global Markets.” She is also completing a new manuscript entitled “Analytical Chemistry: A Handbook of Pharmaceutical GMP Laboratories.”