Professional Training
5.0 (2 Reviews)

Stability Testing For Pharmaceuticals

PTI, Online
Length
2 days
Length
2 days
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Course description

Stability Testing For Pharmaceuticals

Stability failures are responsible for a third of product recalls, costing pharmaceutical companies millions. The risk of not conducting thorough stability testing therefore outweighs the cost of performing it. This interactive 2-day course will provide you with an understanding of the science behind stability testing, a detailed examination of the ICH guidelines, accurate assessments of the tools and techniques to carry out testing. The course will also highlight the fundamentals you need to consider and can transfer back to your work place.

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Suitability - Who should attend?

This course is highly recommended for anyone working in pharmaceuticals, in the following departments, fields or positions:

  • Stability
  • Analytical Chemistry/Methods
  • Formulation Development
  • QA/QC
  • Manufacturing/Production
  • Method Validation
  • Regulatory Affairs
  • GMP Compliance
  • Chemical Engineering
  • Development/Chemistry
  • Outsourcing
  • R&D Analyst / Assistant
  • Stability Officer / Supervisor / Analyst/ Coordinator
  • Analytical Development Engineer

Outcome / Qualification etc.

Stability Testing For Pharmaceuticals

Training Course Content

  • Understand the chemistry principles behind stability studies
  • Design a stability program compliant to ICH/FDA guidelines
  • Analyse stability data and derive your product shelf life
  • Improve efficiency through matrixing and bracketing
  • Comply with current GMP requirements to avoid inspection failure
  • Interpret Q1A, Q1B and Q1E
  • Prepare for FDA inspection of your stability labs
  • Understand the Barr decision and thoroughly investigate OOS stability results

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:

4/5

85% had applied content during the course to their role

Delivery rating:

4/5

Reviews

Average rating 5

Based on 2 reviews.
Reviews are published according to our review policy.
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5/5
R&D Scientist Stability Department, Convatec
23 Jun 2020
Learned a lot

The content of the course was excellent and I learned a lot about regulations that I didn't know. It also included more interaction than other courses I have attended which was ...

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5/5
Stability Team Manager, Custom Pharma Services
23 Jun 2020
Learned a lot

I enjoyed that it was a small group and therefore there were good informal discussions. I attended as a refresher on stability but I've learned a lot.

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