PharmaTraining Limited, Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG, United Kingdom
2011-12-14
Course Objectives 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. Technical Operations. Research and Development Chemistry. QA/QC. Formulation Development. Pharmaceutical & Bioopharmaceutical. Manufacturing/Production. Product Development. Regulatory Affairs. GLP/GMP Compliance. Course Programme
Coffee and registration will be available from 8.30am on Wednesday 14 December, 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.
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