A Few Words About Me
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.
I have been working with Quality Assurance and Quality Control for more than 18 years.
Over the years, I have conducted over 500 QA audits in Europe, USA, Canada, Asia, South America, Africa and the Middle East. Audits related to facilities, documents as well as internal audits and for-cause audits.
Additional work experience includes:
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.
Initiated and lead OECD-GLP highly successful accreditation processes and continuance re-inspections of GLP Laboratories (Bioassay Department at Teva Pharmaceuticals).
Consultancy to manufacturing pharmaceutical company who upgraded from ISO quality level to full GMP accreditation.
On-going consulting to a QC GLP laboratory upgrading from paper based into computerised systems.
QA review for regulatory submissions (NDA, IB, IND, Response letters) - GLP and GCLP aspects.