By attending this intensive two-day seminar, delegates will learn how to:
- Carry out appropriate stability studies and manage stability samples and facilities
- Design stability studies that are suitable for global marketing
- Increase the likelihood of studies receiving regulatory approval
- Save resources on stability testing with potential large financial savings
A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.
Please note that we are delighted to confirm that this course will now also include particulars of the stability of biopharmaceuticals.
Benefits of attending
- Comply with stability requirements for new and existing drug substances, products and line extensions
- Gain knowledge on storage tests, conditions and protocols
- Learn how to design highly efficient protocols for global marketing with potentially large financial savings
- Discover how to manage stability samples and facilities
- Understand what stability testing is required following changes to a product
- Discuss data treatment, shelf-life assignment and extrapolation
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
Paul Palmer,
Paul R Palmer LtdPaul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
Who Should Attend
Personnel involved in:
- Stability testing of pharmaceuticals and biopharmaceuticals
- The design of stability protocols
- The management of stability samples and facilities
- The development of pharmaceuticals which require stability testing
- The production of regulatory documents which include stability data
- Quality assurance
