Colin Booth, vice president science and technology of UK company Oxoid, will speak at the Concept Heidelberg, 'Microbial QC Testing - Reconcile Compliance with Efficiency' workshop.
Colin Booth, vice president science and technology of UK company Oxoid, will speak at the Concept Heidelberg, 'Microbial QC Testing - Reconcile Compliance with Efficiency' workshop that is being held in Barcelona, Spain on 29-31 March 2006.
The methods for microbiological QC found within pharmacopoeias are regarded as being validated - but it is up to each company to prove that these official methods function in their environment, for their products.
With the validation of microbiological test methods consuming a great deal of time, money and human resources, the challenge is to fulfil regulatory requirements within financial targets set by management.
Booth will present the session on 'Validation Requirements', during which he will advise on how to design a validation strategy, with worked examples of validation for creams, liquids and tablets.
He will follow this with a look at sterility test validation and why so many laboratories get it wrong.
Validation of difficult formulations will also be discussed and the question 'validation and robustness - are they the same thing' will be addressed.
This session will close on how to successfully transfer methods to other laboratories.
'Materials Needed for the Validation' is the topic for Booth's second session.
Here he will cover the selection and maintenance of microbial cultures, how to make, store and test culture media, routine validation of the QC laboratory and how to manage stock.
In his final session on 'Change Control and Training of New Personnel', Booth will focus on how to make a change control process robust and how to provide a structured training programme for microbiologists.
In an interactive workshop on 'Endotoxin Testing', Booth will, with delegates, explore examples of faults that have occurred in routine testing, and how to fix them.
The major part of this workshop will concentrate on the problems of validating the assay both in gel clot and kinetic chromogenic assays.
Participants will review data from real examples and discuss the options for resolution of the issues.
