Top Challenges to Build Quality Systems in Analytical and Stability Laboratories
Pharmaceutical Quality System (PQS) is the foundation of pharmaceutical development and commercialization to support Good Manufacturing Practices (GMPs) regulations. Decisions must be made based on science and risk-based approaches. This session will introduce PQS and its building blocks to support the analytical and stability laboratories. It will also discuss analytical challenges to maintain a Quality Management System and support the product lifecycle that focuses on the patient. The following topics will be discussed:
- Quality Systems in the Analytical laboratories
- Establishment of Validated State
- Management of Incidents and Deviations
- Continuous Improvement and Lifecycle Management
- Product Lifecycle Management
Speaker:
Kim Huynh-Ba, Executive Director, Pharmalytik Consulting & Training;
Editor of the “Handbook of Stability Testing for Pharmaceutical Products: Regulations, Methodologies and Best Practices”
Kim Huynh-Ba is the Executive Director and CEO of Pharmalytik Consulting and Training Services (www.pharmalytik.com). She provides consulting and training services to pharmaceutical companies, including those operating under FDA’s Consent Decree. She has over 28 years of experience supporting the development of Quality System Management (QSM), risk management, project management, strategic drug development and stability sciences.
She is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT), teaching pharmaceutical analysis, quality audit, ICH Quality guidelines and GMPs. Kim is also an instructor on cGMP compliance and quality topics for several global organizations such as ACS, AAPS, Pittsburgh Conference, and US Pharmacopeia.
Currently, she is a member of the USP Council of Expert, chairing the Small Molecules 4 Expert Committee. Kim is also a member of USP Impurities of Drug Products Expert Panel and Supplier Qualification Expert Panels. Kim is a member-at-large of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. Kim is part of the Steering committees of AAPS Stability, Pharmaceutical Impurities, and CMC Focus Groups. Kim is also an Alternate Councilor of ACS-Delaware section. She can be contacted at kim.huynhba@pharmalytik.com
Who Should Attend:
Personnel involved in QC, QA, Analytical Method Development, Quality Operations, Manufacturing and Investigations, R&D, Compliance, Contract labs.
Registration Information:
The registration fees for IPA webinars/online events are per person basis, whether delegates are attending together from a conference room or from separate locations.
1 Attendee: $208 + HST CAD per session
2 Attendee: $356 + HST CAD per session
3 Attendee: $488 + HST CAD per session
4 Attendee: $589 + HST CAD per session
5 Attendee: $658 + HST CAD per session
To register for a Group of 6 or more, please contact us at enquiry@ipacanada.com
Log in information will be provided 24-48 hours prior to the webinar.
All participants will receive an e-Certificate of training 2 weeks after the live presentation.
