As an independent senior consultant I provide training and consultancy services for national and inter-national pharmaceutical and healthcare industry in the area of GCLP and GLP.

 

Consultancy

  • Quality Management System
  • Quality Assurance Program
  • Quality Document System
  • Development and writing of SOPs
  • GCLP/GLP implementation and compliance
  • Veterinary pharmacovigilance system

 

Training

OECD series of the Principles for Good Laboratory Practice (GLP)
No 1: OECD Principles on Good Laboratory Practice (as revised in 1997)

GLP consensus documents

No 4: Quality Assurance and GLP (revised 1999)
No 5: Compliance of Laboratory Suppliers with GLP Principles (revised 1999)
No 6: The Application of the GLP Principles to Field Studies (revised 1999)
No 7: The Application of the GLP Principles to Short Term Studies (revised 1999)
No 8: The Role and Responsibilties of the Study Director in GLP Studies (revised 1999)
No 10: The Application of the Principles of GLP to Computerised Systems (1995; replaced by No 17: April 2016))
No 13: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (2002)

Advisory Documents of the Working Group on GLP

No 11: The Role and Responsibility of the Sponsor in the Application of the Principles of GLP (1998)
No 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP (2007)
No 17: Application of GLP Principles to Computerised Systems (April 2016)
[Note: this document replaces Consensus Document No. 10: The Application of the Principles of GLP to Computerised Systems]

No 19: Management, Characterisation and Use of Test Items (April 2018)

Position papers

No 18: The Relationship between the OECD Principles of GLP and ISO/IEC 17025 (2016)

The Use of Laboratory Accreditation with reference to GLP Compliance Monitoring (1994)

 

GCLP

Reflection paper on laboratories that perform the analysis or evaluation of clinical trial samples (2012)