home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops  
 

Stability Testing in Pharmaceutical Development and Manufacturing http://www.pharmatrainingservices.com/StabilityTesting.htm

 
  January 15, 2009  
     
 
PharmaTraining Services, London
2009-15-01


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

 
 
Organized by: PharmaTraining Services
Invited Speakers:

Dr Michael Gamlen

 
Deadline for Abstracts: N/A
 
Registration: £1160.00 + £174 = £1334.00 Total
E-mail: judy@pharmatrainingservices.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.