Next date to be confirmed
Venue
Speaker Michael Gamlen
Cost £600.00 + VAT UK (Total £705.00)
Early-bird rate £540.00 + £94.50
VAT UK (Total £634.50)
Discounted rate £1584.00 + VAT UK
(Total £1861.20) when booked with Stability Testing in Development and Manufacture
Early-bird rate £1425.53 + £249.47 VAT UK
(Total £16750
Overview
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 photostability fit in the overall stability testing program?
• Why does photostability matter? (exercise)
Who will benefit: The course is designed for people working in:
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Course Programme
Coffee and registration will be available from 8.30am on Wednesday 30th June, 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
Practicalities
• Light source selection - Options 1 and 2
• Sample presentation
• Humidity and temperature control
• Selecting sample containers
Forced degradation: Practical and regulatory aspects of photostability
stress testing
• 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
Delegate Workshop
Problems and issues for discussion
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.
