Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
Become a Member | Sign in
Home>Events>This Event
  Events - November 2012


Stability Testing in Pharmaceutical Development and Manufacturing (2 day)

21 Nov 2012 - 22 Nov 2012 - Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG



Bookmark and Share


Course objectives
New and important techniques in stability testing are facilitating product development using the
Quality by Design approach.  Using these it is possible to develop products more quickly and
reliably, through improved methods of shelf life prediction and excipient testing.  New stability
testing protocols using the published ASAP method from Pfizer can generate information quickly and reliably. The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing in a highly interactive, relaxed environment: 

• Why is stability testing required for product registration and GMP purposes?
• What are the requirements for Clinical Trials, new, and existing products?
• How can stability testing be applied during product development to shorten development times as well as improve product quality
• Stability testing outsourcing - successful management and execution

It will include:
• A comprehensive review of ICH stability testing guidance ICH Q1A
• Pitfalls in stability testing.  Outsourcing—costs and benefits
• New approaches to stability testing including ASAP  and the role of peroxides in product
stability
• Stability Testing and QbD
• Workshops for attendees to present and discuss their own stability testing issues with the group 

Who will benefit:
The course is designed for people working in:
• Analytical and Product Development 
• Analytical Chemistry
• Stability Testing 
• Formulation Development 
• Regulatory Affairs 
• Pharmaceutical & Biopharmaceutical Production 
• Quality Control and Quality Assurance
• Technical Operations 

Course Programme
Day 1
The course will commence at 8.30 with registration and coffee, course proper will commence at 9.00 and finish at 5.00pm each day
Introductions
• The life cycle approach to product development and Quality by Design
• Stability testing in product development
• ICH Q6 – specifications, and how to set them.  Role of specifications in stability testing.  Alternative approaches to deriving specifications
Lunch
• ICH Guidance Q1A (R2) – a comprehensive review
• Case study 
“Effect of Processing and Formulation Variables on the stability of a salt of a weakly basic drug candidate (tablet)” – Badawy et al, BMS
• EU GMP guidance on stability testing
 
DAY 2
• Evaluation of stability data – ICH guidance Q1E.  Identifying out of trend data.  Alternative approaches.
• Data interpretation case studies including attendee problems
Lunch
• Bracketing and matrixing designs for stability testing of new drug substances and products - ISC Q1E
• Photostability testing—Q1B
• Action Planning and Final Q&A
Workshop and examples based on delegate’s interests
Group discussion, problem solving and consultancy
 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 .                                             
 
Speaker:
Dr Michael Gamlen is Managing Director of Pharmaceutical Development Services Ltd, 
a pharmaceutical consultancy based in Nottingham (UK).  Dr Gamlen has over 30 years 
experience of tablet development. Awarded a First Class Honours degree in Pharmacy, 
specialising in Pharmaceutical Engineering, he studied for a PhD at Nottingham University.  
He was Head of Tablet Development at the The Wellcome Foundation for 15 years, and
worked as an outsourcing manager before starting his consultancy business in 2000. 
 
Dr Gamlen specialises in managing product development, formulation, tablet and process 
development studies.  He has been teaching professional tabletting courses for many years and
his courses are highly rated, exceeding the expectation of the participants in many cases.
 
Michael continually updates the content of his courses with the latest guidance and   extracts of up-to-the minute scientific papers.  
 
He provides a substantial body of relevant literature to all course participants  as well as copies of all notes and guidance used and a workbook.  He is a   popular and highly respected presenter.
 



Further information
Scientific News
A New Platform for Discovering Antibiotics
Harvard chemists hope to shorten time, difficulty in measuring their effectiveness, potential.
The Need for Speed
Evaluating MALDI-TOF as a high-throughput screening technology for the pharmaceutical industry.
Antarctic Sponge Extract Kills MRSA
New findings may provide opportunity for developing new drugs to fight dangerous bacteria currently highly resistant to treatment.
US-India Collab Finds Molecular Signatures of Severe Malaria
Study may be a significant advancement in understanding the causes of severe malaria.
Novel Way to Prevent Deadly Bacterial Infections
Monash scientists may have found a way to stop deadly bacteria from infecting patients. The discovery could lead to a whole new way of treating antibiotic-resistant “superbugs”
Gene Expression Controls Revealed
Researchers have modelled every atom in a key part of the process for switching on genes, revealing a whole new area for potential drug targets.
An Old-New Weapon Against Emerging Chikungunya Virus
Researchers utilize existing drugs to interfere with host factors required for replication of Chikungunya virus.
Using Gene-editing Technology for Faster, Cheaper Antiviral Drug Development
UCLA scientists are working to develop special screening libraries based on a gene-editing technology called CRISPR.
Can Gender Play A Role In Determining Cancer Treatment Choices?
MD Anderson study reveals “sex-biased” gene signatures in review of 13 cancer types.
New Autism Blood Biomarker Identified
Researchers at UT Southwestern Medical Center have identified a blood biomarker that may aid in earlier diagnosis of children with autism spectrum disorder, or ASD.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!