Available as an In House Training Course
Stability Testing in Pharmaceutical Development and Manufacturing
Dates
24 & 25 June 2008
Venue
The Baltic Exchange, London UK
Duration
2 Days
Cost
£1160 + VAT £203 Total £1363.00
Course objectives
The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing
Why is stability required?
What are the requirements for Clinical Trials, new products, and existing products?
How can you ensure that your programme meets worldwide requirements?
It will include
A comprehensive review of ICH guidance
Interpreting data using statistics
Pitfalls in stability testing
Outsourcing—costs and benefits
Who should attend
The course is designed for people working in:
Analytical Development
Analytical Chemistry
Stability Testing
Formulation Development
Regulatory Affairs
Pharmaceutical & Biopharmaceutical Production
Product Development
Technical Operations
Numbers in our courses are limited to ensure that participants have the opportunity for thorough discussion of the issues to be covered and individual attention from our top-ranked Speakers
Course Speakers
Course Programme
DAY 1
Stability testing in context - what we do and why
Preclinical
Clinical trial
Formulation development
Product registration
Post approval
History of stability testing
How we got to where we are
Role of ICH
Overview of ICH guidance relevant to stability testing
Stability testing
Impurities
Specification
Detailed review of ICH stability testing documents ICH Q1A
Analytical Method Selection and Development
Defining and setting specifications - ICH Guidance Q6A
Preclinical
Clinical trial
Product registration
analytical Method Validation
Key techniques
Method Selection
Outsourcing of stability testing
DAY 2
Matrixing and bracketing pitfalls and purpose - ICH guidance Q1D
Quality systems issues
Safeguarding data quality
Shelf lives and expiration dating - interpreting and using data
Applying ICH Guidance Q1E
Out spec and out of trend data. Assessing outliers
Photostability testing of new dosage forms ICH Q1B
History, purpose and implementation of guidance
Applications/case studies
Case 1 syrup preformulation paper
Case 2 tablet formulation selection
Case 3 Definitive testing
Case 4 Busulfan liquid
Group discussion, problem solving and consultancy
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