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Medical Product Stability Function Overview

 
  November 01, 2018  
     
 
CfPA-The Center for Professional Advancement, Online Live
January 8, 2019 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This course is intended for professionals working within the Pharmaceuticals, Biologicals, Medical Devices, Consumer Products and Veterinary industries. It will be valuable to Scientist, Specialist, Analyst, Supervisors and Managers involved in the QA/QA and Analytical Sciences departments. Stabilitarians and Product Stability Managers, Sample Control Specialists, Analytical Chemists, Microbiologists, QC/QA and RA Professionals, Manufacturing Liaisons, Packaging Liaisons and Research & Product Development Scientists will benefit greatly by attending this training.

Course Description
This 90 minute accredited training provides an overview of the operations (excludes testing and data analysis) aspects of the Stability function as practiced by the pharmaceutical, biological and medical device industries. Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance and monitoring, trending data and sample management.

Preparing for inspections and auditing of the stability function will also be covered. Considerable attention will be given to risk management as applied to all aspects of Stability Operations.

The impact of several stability guidances (ICH, WHO, and FDA, among others) on Stability Operations will be discussed. Each segment concludes with a time for questions and answers as well as a unit quiz for the participant to demonstrate comprehension of the Stability Operations concepts presented.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   John O’Neill, Stability Information Specialist, Nagano Science USA; Founder and Facilitator of the Pharmaceutical Stability Discussion Group

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 44 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, and Associate Director for Stability at both Gilead and Regeneron. Mr. O’Neill currently serves as Stability Information Specialist for Nagano Science USA. He is a past chair of the Stability Working Group of the International Pharmaceutical Federation and is a member of the Product Quality Research Institute Stability Working Group for Shelf Life. Mr. O’Neill is a frequent conference speaker on stability topics. For the past 30 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.

Past participants in Mr. O’Neill’s industry programs have reported that he is knowledgeable, engaging, and a great story teller; bringing practical information backed by real-life experiences.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
 
 
   
 
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