My experience in Quality Management in a Pre-Clinical Company (CRO) and later as a Senior Global Auditor in a large global pharmaceutical company gives me a broad perspective and expertise in a wide variety of implementation methodologies related to GLP/GCLP Compliance.
Auditing across the world makes me a one person benchmark, understanding many ways of doing the right/compliance thing. I will assist you to tailor your procedures according to your needs, under the relevant compliance umbrela.
A Few Words About Me
I have been working in the Quality Assurance arena for more than 20 years.
Over the years, I have conducted over 600 QA audits across Europe, USA, Canada, Asia, South America, Africa and the Middle East. Audits related to CROs facilities, documents as well as internal audits and for-cause audits.
Additional work experience includes:
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Build a QA unit including all SOPs and Quality System at an animal facility CRO. Managing the Quality Assurance unit from a non-regulated environment into successful OECD-GLP Accreditation and continuance re-inspections.
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Initiated and lead OECD-GLP highly successful accreditation processes and continuance re-inspections of Global GLP Laboratories.
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Consultancy to manufacturing pharmaceutical company who upgraded from ISO quality level to full GMP accreditation.
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Consulting a QC GLP laboratory upgrading from paper based into computerised systems.
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Consulting a USA CRO opening a new laboratory in Europe.
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QA review for regulatory submissions (NDA, IB, IND, Response letters) - GLP and GCLP aspects.