COURSE ID 3134

Advanced Stability Operations for Drugs, Biologics, and Medical Devices

Part 3 in a 3-part series

AVAILABLE ON-DEMAND
Duration: 4 Hours
Course Instructor

John O'Neill

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? Our 3-part 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. Depending on your level of understanding, you can enroll in the entire series or attend the only select parts of the series.

ABOUT PART 3 (OF 3)
This accredited course focuses on advanced stability operations. The course examines how to evaluate your program on a risk basis and fine tune the stability function to improve quality and compliance, lower and mitigate risks, increase efficiency and prepare for regulatory audits and inspections.

Attend Part 3 of this series as a stand-alone, OR maximize your learning and take this course and its companion courses:

Introduction to Stability Operations for Drugs, Biologics, and Medical Devices | (Part 1 #3132)

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

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

  • Conduct a comprehensive risk assessment of the Stability function
  • Develop effective metrics
  • Appropriately respond to the “Out of….” situations
  • Prepare for the challenges of outsourcing storage and testing
  • Eliminate common pitfalls in stability function audits

COURSE OUTLINE

Looking Under the Hood

  • Stability Metrics
  • Stability Windows Global Harmonization
    • What to measure and against what standards
  • Risk Management
  • Stability Aught-Ohs:
    • OOE, OOT, OOS, OOC, OOL
    • Dilemmas and Tough Problems
  • Outsourcing
  • Disaster Planning
  • Stability Audit Preparations
Register Now

You will be redirected to our secure system.

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
• 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

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.

Learn more

We’ve rebranded! CfPA is now COBBLESTONE