13 & 14 December 2010
Venue Window Conference Venue, London UK
Speaker Dr Michael Gamlen
Cost £1160.00 +£203 VAT UK (Total £1,363.00)
Early-bird rate £1044.00 + £182.70(Total £1226.70)
if booked and paid by 18 October 2010
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Available as an in-house course
Comments from previous attendees:
"An excellent training course I would recommend"
"Nice and informal. Good having small numbers - able to ask questions as and when"
"Course content good, clear explanations given with examples
of real life studies"
"Speaker very knowledgable and eager to answer questions"
Overview
New and important techniques in stability testing are facilitating product development using the Quality by Design approach. Using these it is possible to develop products more quickly and reliably, through improved methods of shelf life prediction and excipient testing. New stability testing protocols using the published ASAP method from Pfizer can generate information quickly and reliably. The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing in a highly interactive, relaxed environment:
- Why is stability testing required for product registration and GMP purposes?
- What are the requirements for Clinical Trials, new, and existing products?
- How can stability testing be applied during product development to shorten development times as well as improve product quality
- Stability testing outsourcing - successful management and execution
It will include
- A comprehensive review of ICH stability testing guidance ICHQ1A
- Pitfalls in stability testing
- Outsourcing—costs and benefits
- New approaches to stability testing including ASAP and the role of peroxides in product stability
- Stability Testing and QbD
- Workshops for attendees to present and discuss their own stability testing issues with the group
Who should attend
The course is designed for people working in:
- Analytical and Product Development
- Analytical Chemistry
- Stability Testing
- Formulation Development
- Regulatory Affairs
- Pharmaceutical & Biopharmaceutical Production
- Quality Control and Quality Assurance
- Technical Operations
Additional Resources
Online access to comprehensive publications including all relevant guidance will be provided as well as colour copies of all presentations and case studies.
Numbers in our courses are limited to ensure that participants have the opportunity for thorough discussion of the issues to be covered and individual attention from our top-ranked Speakers
Course Programme
DAY 1
Introductions
- The life cycle approach to product development and Quality by Design
- Stability testing in product development
Lunch
- ICH Guidance Q1A (R2) – a comprehensive review
- Case study
"Effect of Processing and Formulation Variables on the stability of a salt of a weakly basic drug candidate (tablet)" – Badawy et al, BMS - EU GMP guidance on stability testing
DAY 2
- ICH Q6 – specifications, and how to set them. Role of specifications in stability testing. Alternative approaches to deriving specifications
- Evaluation of stability data – ICH guidance Q1E. Identifying out of trend data. Alternative approaches.
- Data interpretation case studies including attendee problems
Lunch
- Bracketing and matrixing designs for stability testing of new drug substances and products - ISC Q1E
- Photostability testing—Q1B
- Action Planning and Final Q&A
Workshop and examples based on delegate’s interests
Group discussion, problem solving and consultancy
