Establishing Validation for an Analytical Method to Monitor Organic Impurities

Changes in the Active Pharmaceutical Ingredients (API) and drug products can cause an increase of organic impurities or the formation of new impurities. Therefore, monitoring impurities are considered a critical activity to ensure the quality of pharmaceutical products. This session will discuss different regulations that impacting the control strategies of impurities in pharmaceutical products and the establishment of method validation to monitor these impurities.  It will also examine the validation protocol and strategies for impurity analytical methods.

Topics will be covered:

• Understand regulatory expectations surrounding impurities in API and Drug Products
• Discuss deficiencies citations related to impurity controls.
• Design validation study for the analytical method for specified and unspecified impurities
• Establish stability indicating method to distinguish process impurities and degradation products.
• Discuss FDA, WHO, and USP initiatives on monitoring organic impurities

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:

Note: This Webinar scheduled for September 23 is cancelled.
For more details, please contact us at Email: enquiry@ipacanada.com