COURSE ID 3132

Introduction to Stability Operations for Drugs, Biologics, and Medical Devices

Part 1 in a 3-part series

AVAILABLE LIVE ONLINE
Date(s) and Time:
October 28, 2024
12:30 pm EDT - 5 pm EDT
Duration: 4 Hours

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

John O'Neill

Early-Bird Offer

Limited Availability until October 14, 2024

$ 525
Price
$ 585
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

New to “stability”, or a key stakeholder in the stability process, or just want to firm up your stability knowledge? This series on Stability Operations for Drugs, Biologics, and Medical Devices will give you a rock-solid base for establishing or expanding your stability operations knowledge.

This accredited course is part 1 of a 3-part series that focuses 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 in three ascending segments for those beginning in the Stability Function, those performing the myriad of duties associated with the Stability Function and those managing advanced tasks, wrestling with complex problems, and preparing to face regulatory audits of Stability Operations.

Attend this course as a stand-alone, OR maximize your learning and take this course and its companion courses:

Intermediate Stability Operations for Drugs, Biologics, and Medical Devices | (Part 2 #3133)

Advanced Stability Operations for Drugs, Biologics, and Medical Devices | (Part 3 #3134)

Upon completion of this course, you will be able to:

  • Classify the entire spectrum of elements of the Stability Function
  • Outline stability expectations from each phase of the product life cycle
  • Show the impact of stability regulations and guidance’s
  • Identify key components of stability SOPs
  • Identify and partner with key stakeholders in the stability function
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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 on 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
• Packaging Liaisons
• Research & Product Development Scientists Managers
• Analytical Chemists, Microbiologists
• QC/QA Professionals
• Manufacturing Liaisons
• Calibration and Validation Specialists
• Facilities/HVAC Staff
• Pharmaceutical Consultants
• Regulatory Affairs Personnel

Course Instructor

John-O’Neill

John O'Neill

Editor, stabilityhub.com

John O'Neill’s Courses

Accreditation

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