Stability Testing in Pharmaceutical Development and Manufacture

Venue: London

Location: London, United Kingdom

Event Date/Time: Dec 03, 2009 End Date/Time: Dec 04, 2009
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Stability Testing in Pharmaceutical Development and Manufacturing

Dates: to be advised 2009 Venue:

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

A reduced rate is available if booked with "Analytical Method Development and Validation"

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
* Interpreting data using statistics
* Pitfalls in stability testing
* Outsourcing—costs and benefits

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

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


Stability testing in context - what we do and why

* Preclinical
* Clinical trial
* Formulation development
* Product registration
* Post approval

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
* Specification

Detailed review of ICH stability testing documents ICH Q1A

Analytical Method Selection and Development

Defining and setting specifications - ICH Guidance Q6A

* Preclinical
* Clinical trial
* Product registration

Analytical Method Validation

* Key techniques
* Method Selection
* Outsourcing of stability testing


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

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

Group discussion, problem solving and consultancy