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>About me
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I am an independent consultant for the pharmaceutical,
agrochemical and chemical industries, based in the UK. I specialise
in providing advice, audits and training to Companies within these
industries that need to operate to Good Laboratory Practice (GLP)
and Good Clinical Practice (GCP) regulations worldwide.
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My strength is in my vast experience
and knowledge of the regulations and how they should be interpreted
for a particular company and/or situation, particularly the GLP regulations
that apply to non-clinical safety studies. This comes from my
experience as a GLP inspector with the UK MHRA, a position I held
for over 9 years. During this time I conducted over 250 inspections.
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As an independent quality assurance auditor
and consultant, I have advised many clients and sponsors worldwide about
the regulatory requirements for both GLP and GCP. I can conduct third
party audits, mock inspections, locum quality assurance services and training
courses and advise on the regulatory aspects of computerised systems.
In addition, with the advent of the EU GCP clinical trial directive,
I can advise and audit clinical laboratories against the regulatory requirements
and industry expected standards. |
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