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PSDG Stability Testing Special Focus Training:

Collaborative Stability Testing: Speed, Savings, and Success

Thursday, November 7, 2024

11:00 AM – 4:15 PM ET 

KENX PSDG Training Event Overview:

What you need to know about the Stability Laboratory/Operations/Stakeholder Paradigm to boost efficiency, reduce costs, and improve compliance.

The Medical Product Stability function is often configured in 3 divisions:

  • The Stability Group (or “Stability Operations”) that plans and arranges for the conduct of stability studies.
  • The laboratories that develop methods, set specifications, and carry out the required testing.
  • The wide array of stability stakeholders that provide input to, and rely on output from, the stability process.

When the role and function of any one of these divisions is misunderstood by the others, errors, delays and compliance issues can arise. Today’s training event focuses on the critical aspects of the stability testing laboratory and what Analysts, Operations staff and Stakeholders can do to optimize the overall Stability function. Knowledge is power, and your stability program will get a powerful boost through the information exchanged and questions answered in this program.

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FACULTY

John O’Neill

Editor, StabilityHub.com , Facilitator, PSDG

John O’Neill earned his Bachelor’s degree in Pharmaceutical Sciences from Columbia University and a Master’s in Health Systems Management from Union University. His career of 50 years has taken him from Registered Pharmacist to

  • Liquids and Semi-solids Formulator at Sterling Winthrop
  • QC Manager at Sanofi-Aventis
  • Medical Device Quality Steward at Boston Scientific
  • Independent Consultant
  • Principal Stability Specialist for Biologics at Genentech
  • Associate Director for Stability at both Gilead and Regeneron

He is a past chair of the Stability Working Group of the International Pharmaceutical Federation and was a member of the Product Quality Research Institute Stability Working Group for Shelf Life. Mr. O’Neill has been a frequent conference speaker on stability topics. For the past 36 years he has been the Facilitator of the Pharmaceutical Stability Discussion Group, which has made him privy to just about everything that can go wrong or right with the Stability function.  Mr. O’Neill currently serves as the Editor of the stability information website- StabilityHub.com.

Lori McCaig

Director, Global Stability Program Management, Seagen, Inc.

Lori McCaig, Ph.D., is Director of Global Stability Program Management at Seagen Inc., responsible for standards, governance, innovation, and oversight and management across stability programs throughout the product lifecycle.  Before joining Seagen she led Global Stability Program Management at Genentech/Roche and previously held leadership positions in stability, lab, and quality management at several companies.  Lori enjoys collaborating with stability colleagues across industry.   She has served on the USP Biologics Stability Expert Panel and Physical Stability Subcommittee, is the current AAPS Stability Community Chair, has provided stability trainings to health authorities and university students, and collaborates in other industry stability workgroups.

Chris Latoz

Stability Manager, Hollister Incorporated 

Christopher (Chris) V. Latoz earned his Bachelor Degree in Chemistry and Mathematics from Illinois State University, and his Master’s Degree in Analytical Chemistry from Illinois Institute of Technology. Chris has over 28 years’ experience in the medical device industry (Class I and II devices) working in R&D, Materials Characterization, and Stability. Currently, he is Stability Manager at Hollister Incorporated in Libertyville, Illinois. While at Hollister, Chris has led several process and capacity improvement projects, including: the implementation of a LIMS (Laboratory Information Management System) for stability sample and data management; the construction of new walk-in stability storage chambers; and the implementation of a continuous temperature and humidity monitoring system for stability chambers.

John J. Long, Ph.D.

Quality and CMC Leader, Large Molecule Therapeutics

Over 25 years experience working primarily in the analytical space covering early stage through commercialization with extensive knowledge across vaccines, biologics, and gene therapy. Working in the GMP space has provided me with a strong background in all aspects of GMP encompassing QC release and stability; investigations including deviations, change control, and CAPAs; and regulatory/CMC support including inspections and filings. This work encompasses primarily large molecule therapeutics across vaccines, biologics and gene therapy. Blending practical experience in laboratory management, GMP principles, and regulatory guidances has made me uniquely qualified across multiple areas of laboratory compliance. Working cross-functionally both internally and externally has provided me with a valuable perspective on stability and the associated complexities.

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