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

Stability Testing in Pharmaceutical Development and Manufacturing

 
  April 01, 2013  
     
 
PharmaTraining Ltd, London UK
14 & 15 May 2013


This course has been updated to reflect the recent changes in the pharmaceutical stability testing world.

The new course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly testing area. It will include opportunities for review of specific participant problems.

The course will cover:

Recent regulatory changes affecting stability including

  • The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
  • Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
  • Product Quality Reviews and the interpretation of stability data.

Recent scientific developments with implications for stability, with a particular focus on cost reduction, shortening of development timelines, and improvements on existing interpretation systems

  • ASAP - using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence - Freethink Technologies' ASAPprime
  • Low level impurities and their impact on product stability
  • Manipulation of tablet internal pH to improve product stability

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

 

 
 
Organized by: PharmaTraining Ltd
Invited Speakers: Dr Michael Gamlen
 
Deadline for Abstracts: .
 
Registration:

Registration Fee: £1180 + UK VAT if applicable

Registration is available online at:http://www.pharma-training-courses.com/stability-testing-in-pharmaceutical-development-and-manufacture_10.htm

E-mail: judy@pharma-training-courses.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.