Introduction to Photostability
23 Nov 2012 - 23 Nov 2012 - Islington, London,
All PharmaTraining courses focus on two key objectives. These are to provide attendees with knowledge - information, which will assist you in making better judgements - and skills, which will allow you to apply the knowledge you have received. We guarantee to engage your interest and commitment on the course, and we expect our training to improve your effectiveness.
About this course
The purpose of this course is to give an overview of photostability,and where it fits in the stability testing programme and the importance of photostability. The course is highly interactive and held in a relaxed environment.
It will cover:
. Why do we do photostability tests?
. Concepts and background in photostability
. Identifying drug substances most likely to absorb light and display signs of poor photostability
. Understanding photostability terminology
. Where does phototstability fit in the overall stability testing program?
. Why does photostability matter? (exercise)
Who will benefit: The course is designed for people working in:
. Analytical Development
. Analytical Chemistry
. Stability Testing
Coffee and registration will be available from 8.30am, course proper will commence at 9.00am. We anticipate the course will finish at 5.00pm.
Formulating and manufacturing unstable products
. Formulation development and evaluation for photolabile materials
. Protection during the manufacturing process
. Getting the product to the patient
ICH guidelines for photostability testing: Using ICH Q1B guidance in practice
. understanding the terms and procedures used in the guideline
. Light source selection - Options 1 and 2
. Sample presentation
. Humidity and temperature control
. Selecting sample containers
Forced degradation: Practical and regulatory aspects of photostability
. Selecting experimental conditions for stressing samples with respect to light
Meeting regulatory requirements
. Documentation – principles and practice
. Stability testing and the Quality System
. SOPs for stability testing
. Equipment validation and calibration – do the chambers work?
. Protocol development and approval
Reporting stability test data
Problems and issues for discussion
Online access to comprehensive publications including all relevant guidance will be provided as well as colour copies of all presentations and case studies.
. Technical Operations
. Research and Development Chemistry
. Formulation Development
. Pharmaceutical & Biopharmaceutical Manufacturing/Production
. Product Development
. Regulatory Affairs
. GLP/GMP Compliance
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 product stability testing.
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
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.