Available as an In House Training Course

 

Stability Testing in Pharmaceutical Development and Manufacturing

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Dates

24 & 25 June 2008

Venue

The Baltic Exchange, London UK

Duration
2 Days

Cost

£1160 + VAT £203  Total £1363.00

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 Speakers

Dr Michael Gamlen

Eve Roodhouse

 

Course Programme

 

DAY 1

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

 

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

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

 

 

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