Course will not run in 2023!
Learn to design a compliant pharmaceutical stability program you can apply in your workplace, overcoming common challenges
Stability testing is a major requirement in the development of a pharmaceutical product to determine the versatility of a drug substance when exposed to certain conditions such as heat, pH, humidity, and radiation. It is vital for patient safety to know how a drug product will change over time and to provide adequate advice for the storage and disposal of the product. 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 course will provide you with an understanding of the science behind stability testing, a detailed examination of the ICH guidelines, and accurate assessments of the tools and techniques to carry out testing. Crucially you will gain a deeper understanding of the guidelines and how best to create stability protocols to maintain compliance.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org.
What will you learn?
Understand the chemistry principles behind stability studies
Stability program design
Design a stability program compliant to ICH/FDA guidelines
Analyse stability data and derive your product shelf life
Matrixing and Bracketing
- 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
Who is this course for?
This course is highly recommended for anyone working in pharmaceuticals, in the following departments, fields or positions:
- Analytical Chemistry/Methods
- Formulation Development
- Method Validation
- Regulatory Affairs
- GMP Compliance
- Chemical Engineering
- R&D Analyst / Assistant
- Stability Officer / Supervisor / Analyst/ Coordinator
- Analytical Development Engineer
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
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 great.
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others