Intermediate Stability Operations for Drugs, Biologics, and Medical Devices

AVAILABLE ON-DEMAND

Duration: 4 Hours

Course Instructor

John O'Neill

.4 CEUs

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 series.

ABOUT PART 2 (OF 3)
This accredited course will aid those stepping into, or currently employed in, a hands-on role in Stability Operations. This course provides an intermediate analysis into the critical elements of a well-oiled stability function and helps you make higher contributions to the Stability Team.

Attend Part 2 as a stand-alone course, 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)

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

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

Build stability protocols to cover every Operations phase of the Stability Life Cycle
Establish a highly effective Stability Review Board
Operate a secure stability area with a high degree of sample control
Maintain a reliable system of stability chambers
Assess the adequacy of your statistics and trending measures

COURSE OUTLINE

Managing Stability Studies
Building Phase-appropriate Stability Protocols
Stability Review Boards
Stability Planning, Space Calculation & Financial Budget
Stability Lifecycle Budgeting
Leveraging & Equivalence
Laboratory Information Management Systems (LIMS)
Statistics
Stability Reports for Stakeholders, Management, and Regulatory
Stability Chambers
Chamber Excursions
Sample Control

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Who should
attend?

LEVEL

Intermediate

INTERESTS

Biotechnology / Biopharmaceutical Cosmetics / Personal Care & Skin Care 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
• 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

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