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Stability Testing in Biological Product Development and Manufacture (2 day)

  July 26, 2011  
PharmaTraining Limited, Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG
12 & 13 December 2011

Course Programme
Start time: 8.30 Coffee/tea and registration, course proper 9.00 and we
anticipate the course will finish at 17.00.

Day 1
• The life cycle approach to product development and Quality by Design
• Stability testing in product development
• 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


• Key techniques for analysing biological products
• ICH Q5C Stability testing of Biotechnological/Biological Products. Taking
account of the unique properties of biological materials.
• “ICH Q6B Specifications: Test procedures and acceptance criteria for
Biotechnological/Biological Products”. Role of specifications in stability
testing. Putting the guidance into practice. Approaches to identifying and
handling out of trend data.
• Bringing it all together—using stability data in Marketing Authorisation
Applications including the Quality Overall Summary.
• Workshop—bring your data for review and evaluation
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 .

Organized by: PharmaTraining Ltd
Invited Speakers: Dr Michael Gamlen is Managing Director of Pharmaceutical Development Services Ltd, a
pharmaceutical consultancy based in Nottingham (UK). 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 Pharmaceutical
Development Services Ltd in 2000.
Dr Gamlen has been teaching professional courses for many years. His courses are highly rated,
exceeding the expectation of the participants in many cases. He continually updates the content of
his courses with the latest guidance and extracts of up-to-the minute scientific papers and 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.
Dr Lesley Chaplin is a biopharmaceutical consultant with over 20 years experience in the industry
gained at UCB-Celltech, Lonza Biologics and other smaller biotechnology companies.
Her experience includes:-
Design of purification processes for cGMP manufacture - Expertise in the scale up of purification
processes from development to pilot and cGMP manufacturing facilities (200 – 5,000L scale) in the
UK and the US.
cGMP — documentation work including change controls, manufacturing process description creation,
batch record creation, deviation close-outs. BMR and batch record review (pilot aond manufacturing
campaigns). Writing CMC sections of IND and IMPD’s for license applications. Assistance with the
preparation of a BLA package for regulatory authorities. Liason with regulatory, documentation, QA
and manufacturing. GMP review of stability studies. GMP audits – including internal and external
audits . Report writing and review. Writing and reviewing manufacturing deviations representing
both manufacturing and QA.
Project management - including Planning and coordination of purification projects, including
transfer to pilot scale and cGMP manufacturing scale. Development project management.
Continuous Improvement - projects utilising Six Sigma techniques – problem solving,
troubleshooting, improvement projects.
Compliance Management - Development of QMS / GxP training programme, audit schedules,
metrics for continuous improvement and monitory of GxP activities.
QA – technical review of cGMP documents e.g., analytical protocols, reports, master batch records,
batch records, specifications etc.
Data collation and analysis — Evaluation and introduction of new technologies and improvements
into the workplace.
Deadline for Abstracts: ..

Stability Testing in Biological Product Development and Manufacturing:
12 & 13 December 2011 (early-bird registration 14 October 2011)

2 day course £1180.00 (+ VAT £236.00 if applicable, see VAT NOTES)

2 day course £1062.00 (+ VAT £212.40 if applicable, see VAT NOTES)
if booked and paid eight weeks prior to course commencement   

A reduced rate is available if also booking “Pharmaceutical Packaging—an introductory
course” or “Introduction to Photostability” 14 December 2011                                                                                                                                                                                                                                                           
Discount of 10% applies for booking 8 weeks in advance
Discount of 10% applies for booking more than 1 delegate

Discount of 10% applies for booking more than 1 course
Maximum discount received is 15%

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