The standard for the safety testing of:

 


Pharmaceuticals

Veterinary
Medicines

Agrochemicals

Food and Feed additives

And other, mainly industrial, chemicals

 

CONTINUING PROFESSIONAL DEVELOPMENT

Evidence of Competency after retirement as Senior Inspector with the UK Government

2004

  • 17 Routine inspections for compliance with the principles of Good Laboratory Practice (GLP) on behalf of the UK Government

2005

  • 8 Routine inspections for compliance with the principles of Good Laboratory Practice on behalf of the UK Government
  • QA Consultant for Contract Research Organisation (CRO) carrying out analytical work

2006

  • Audit of 26 week intravenous study in the rat at a CRO on behalf of the sponsor.
  • Inspection of a CRO carrying out analytical work for compliance with GLP on behalf of a sponsor
  • Refresher training given in GLP for management, Study Directors, Quality Assurance (QA) and study staff at a CRO carrying out analytical work
  • QA Consultant for Contract Research Organisation (CRO) carrying out analytical work
  • GLP refresher training at a (CRO) carrying out analytical work
  • Advice on the maintenance of the good practices standards within a CRO carrying out analytical work on the acquisition of laboratories overseas.
  • Presentation to the British Association of Research Quality Assurance (BARQA) Annual Conference on setting quality standards

2007

  • QA Consultant for Contract Research Organisation (CRO) carrying out analytical work
  • GLP training for new staff at a CRO carrying out analytical work
  • Advice on setting up the GLP standard at a CRO carrying out stem cell work.
  • GLP refresher training at a UK government Agency carrying out work on vaccines
  • Provision of standard operating procedures for a QC laboratory
  • 25 Report audits for a UK government agency
  • Attendance at the BARQA Anglia Regional Forum on GxP hot topics
  • Presentation made to Scientific Archivists Group

2008

  • Training client’s GLP QA
  • Attendance at MHRA conference on Statutory GCP Inspections of Clinical Laboratories
  • Attendance at the BARQA Anglia Regional Forum on audits and inspections
  • Practical training for analytical laboratories given to a client

 

 

Email: scilla.cullen@djb-consulting.co.uk Tel/Fax: +44(0)1438 833155


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