Services


Investigator Site Audits

John has conducted numerous investigator site audits across all Phases in Central and Eastern Europe and Asia.  Indications audited include Oncology, Duchene Muscular Dystrophy, Rheumatoid Arthritis, COPD, Cardiology, Urology, Malaria, and Pneumonia and have also involved for cause audits.  John has also mentored junior auditors in this area.


Phase I Unit audits

John was a subject matter expert in Phase I audits whilst working for an independent QA Consultancy organisation.  He spent nearly five years in a Phase I unit as a Quality Auditor, rising to the position of Quality Manager for Europe.   He successfully guided the unit through its first statutory GCP and GMP inspections with the UK MHRA.  In his most recent role prior to forming ClinPark QA, he performed multiple Phase I audits in Europe, USA and South Africa.  He also published several articles in the CQA Newsletter relating to Phase I operations.


Contract Manufacturing Organisations

For the first 14 years of his career, John worked in GMP for a commercial manufacturer of licensed products.  Eight years was spent in QA, where he performed multiple systems and facility audits and was responsible for writing technical agreements with contract acceptors and for auditing to these contracts and cGMP requirements.  On joining the Phase I unit, he applied for the unit’s MIA(IMP) license and successfully hosted the pre-authorisation inspection with the MHRA.  He was named as the person responsible for quality on the licence and was the key contact with the regulatory authority.  In his last role, he was the subject matter expert for GMP.


Laboratory Audits

John has conducted laboratory audits for GMP, GCP and GLP.  This has included QC laboratories testing raw materials and finished products, central laboratories for clinical trials and laboratories undertaking sample analysis from pre-clinical toxicology studies.  John hosted the second ever joint GCP/GLP MHRA inspection at a GLP laboratory belonging to the Phase I organisation where he worked.


Mock Regulatory Inspections/Regulatory Inspection Preparation

Throughout his 26 year career John has been involved in statutory regulatory inspections.  Whilst working in GMP he was involved in seven GMP inspections.  On moving to GCP, he hosted all inspections at the Phase I unit, including GCP, GMP and GLP.  Expertise includes helping organisations to prepare for a regulatory inspection, providing on-site support during actual inspections and answering inspection reports.  He was one of the subject matter experts in this field during his previous role.


Document Audits

John conducts audits of Clinical Study Reports, Protocols, Informed Consent Forms and Investigator’s Brochures.


Vendors

Usage of third party vendors by Sponsor companies and CROs managing clinical trials is a fundamental part of the clinical trial process.  During his auditing career John has performed audits of many types of service provider, including monitoring, IVRS providers, distributors, central ECG laboratories, medical writers and more.


Trial Master Files and Archives

John has conducted audits of Investigator Site Files for studies conducted at the Phase I unit where he worked and also during Investigator Site audits.  He has also conducted audits of complete Trial Master Files for large Phase III studies, including paper, electronic and hybrid systems.  Whilst working at the Phase I unit he was responsible for the archiving function and has audited several of the major archiving companies.


Consultancy

ClinPark QA can provide consultancy services. This may include special projects such as due diligence, help with assessing and developing quality management systems, general regulatory advice and interim placements within organisations to provide additional QA support.

 

 

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