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.Do you work at this organisation and want to update this page?
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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.
Write a review!
23 Jun 2020
Learned a lot
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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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 ...