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COURSE ID 2794

Stability Operations for Drugs, Biologics and Medical Devices: Steps to a Successful Stability Function

AVAILABLE On-demand
12 Hours

On-Demand

Offering Price
$ 2330
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Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 1.2 IACET RAPS
View Course Outline

This 12-hour accredited coursefocuses on the operational 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. The course concludes with a workshop for hands-on experience in risk management and auditing of Stability Operations programs.

who should
attend?

LEVEL
Intermediate
INTERESTS
Biotechnology / Biopharmaceutical Clinical Medical Devices / Diagnostics Pharmaceutical Science & Technology

This course is designed to benefit professionals in the Pharmaceutical, Biological, and Medical Device Industries who execute Stability Operations for their company.

Stakeholders who support, rely or otherwise liaise with the stability function would additionally benefit from understanding the requirements and challenges of stability operations.
These include:
– Stabilitarians and Product Stability Managers
– Sample Control Specialists
– Analytical Chemists, Microbiologists
– QC/QA Professionals
– Manufacturing Liaisons
– Packaging Liaisons
– Research & Product Development Scientists and Managers
– Calibration and Validation Specialists
– Facilities/HVAC Staff
– Pharmaceutical Consultants
– Regulatory Affairs Personnel

course instructor

John O'Neill
Editor, stabilityhub.com

John O'Neill’s Courses
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 43 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 29 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.

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