Available as an In House Training Course

Stability Testing in Pharmaceutical Development and Manufacturing

Dates: 28 & 29 June 2010                       

Venue: Window Conference Venue, London

Duration: 2 Days                                Cost: £1160 + VAT £174  Total £1334.00

A reduced rate is available if booked and paid by Friday 30 April 2010 £1044.00 + £182.70 (Total£1226.70)

                                                                                         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"

Course objectives

The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing

• Why is stability required?
• What are the requirements for Clinical Trials, new products, and existing products?
• How can you ensure that your programme meets worldwide requirements?

It will include

• A comprehensive review of ICH guidance
• Pitfalls in stability testing
• Outsourcing—costs and benefits
• New approaches to stability testing including ASAP
• 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 Development
• Analytical Chemistry
• Stability Testing
• Formulation Development
• Regulatory Affairs
• Pharmaceutical & Biopharmaceutical Production
• Product Development
• 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 Speaker:  Dr Michael Gamlen

Course Programme

DAY 1

Stability testing in the new world of QbD
     • Stability testing and the Lifecycle approach to product development
     • Formulation development
     • Manufacturing
History of stability testing
     • How we got to where we are
     • Role of ICH
Overview of ICH guidance relevant to stability testing
     • Stability testing
     • Impurities
     • Specifications

LUNCH

Detailed review of ICH stability testing documents ICH Q1A

Defining and setting specifications – ICH Guidance Q6A
     • Preclinical
     • Clinical trial
     • Product registration
ASAP – a new approach to stability testing the drug product
Question and Answer session

DAY 2
Matrixing and bracketing pitfalls and purpose – ICH guidance Q1D
Quality systems issues
     • Safeguarding data quality
Shelf lives and expiration dating – interpreting and using data.
     • Applying ICH Guidance Q1E
Out spec and out of trend data. Assessing outliers.

LUNCH

Photostability testing of new dosage forms ICH Q1B
     • History, purpose and implementation of guidance
Applications/case studies
     • Case 1 syrup preformulation paper
     • Case 2 tablet formulation selection
     • Case 3 Definitive testing
     • Case 4 Busulfan liquid
Workshop and examples based on delegate’s interests
Group discussion, problem solving and consultancy