Christophe Barcella - President and GxP Auditor

Bordeaux, France

Experience

Sep 2001 - Present

24 years 5 months

Over 34 years of experience in QA and GxP compliance with over 950 audits conducted to date
Project management and regulatory affairs support
Fully knowledgeable in international regulations and guidelines: ICH, EMA, OECD, PIC/S, WHO, EU GDPR and local regulations: FDA, Health Canada, PMDA, TGA, ANVISA, COFEPRIS
Audited investigational and commercial medicinal products including drugs, biologics, peptides, vaccines and medical devices
Office locations in France (Bordeaux, Fontcouverte) and Canada (Montreal)
Compliance audits experience includes:
GLP & GCLP audits
GCP audits
GMP & GDP audits
GVP audits
Expertise in hosting GCP, GMP and GVP regulatory inspections with agencies: EMA, FDA, UK MHRA, BfArM, ANSM, Health Canada, Danish Inspectorate, PMDA
Expertise in SOP and quality management systems development for clinical operations, monitoring, data management, biostatistics, project management, PV, QA, IT
Subject matter expert in GxP compliance auditing training and regulatory submission (CTA, IND) training
Experience in therapeutic areas: Oncology, CNS, Cardiovascular, GI, Internal Medicine, Metabolism, Immunology, Dermatology, Ophthalmology, Anti-Infectives

Jan 2000 - Dec 2001

2 years

Oversaw and coordinated global QA (GCP) and regulatory affairs across Montreal, Edmonton and Paris offices
Organized quality management and regulatory affairs department including supervision, budget planning, resource allocation, training and project planning
Developed BCIRG SOP management system and designed company processes
Managed and conducted worldwide audits of processes, study files, investigator sites, electronic systems, central labs and subcontractors
Provided regulatory support for five phase III studies in chemotherapy and hormone therapy across 35 countries
Coordinated regulatory document review and approval and acted as regulatory intelligence with agencies
Reviewed internal validation plans for web-based registration/randomization and remote data capture systems
Drafted, reviewed and approved all SOPs including quality management, clinical monitoring, randomization, safety, data management, medical writing and regulatory affairs
Coordinated five global clinical trial applications including IND, annual reports and PSUR
Conducted benchmarking for CRO selection and set up investigator compliance database
Performed CSV audits of EDC, pharmacovigilance and site monitoring systems
Conducted multiple training sessions on global GCP, BCIRG SOPs, informed consent, Canadian regulations, FDA financial disclosure, ERES, regulatory inspections and quality management program

Jan 1998 - Dec 2000

3 years

Oversaw and coordinated QA (GCP) function across Montreal and Cambridge offices in conjunction with Transnational QA and operational heads
Advised clinical project managers in Latin America on GCP compliance issues
Managed and conducted file, investigator site, system and vendor audits in Canada, United States and Latin America
Provided Canadian regulatory intelligence and liaised with FDA and TPD inspections
Served as global lead auditor for immunology, allergy/respiratory, anti-infectives and medical devices clinical studies
Assessed project risks and coordinated QA audits and corrective actions
Prepared clinical development plans and coordinated risk management plans
Participated in Y2K compliance program as CSV auditor
Reviewed regulatory content of informed consent and client batch records per cGMP
Authored SOPs and guidance documents for Canadian operations
Delivered training sessions on FDA financial disclosure, ERES regulations and company SOPs
Prepared global GCP audit plans and conducted internal audits and investigator site audits in the Americas

Jan 1997 - Dec 1998

2 years

Supervised QA/QC unit of five staff
Established regulatory compliance programs under cGMP, GLP and GCP
Conducted audits of ongoing clinical studies including TMF, investigator sites, ethics committees, laboratories and CROs
Organized regulatory affairs department and coordinated submissions to FDA CDER and Health Canada TPD
Participated in preparation and approval of validation master plan for production and QC testing
Implemented operational quality plans in clinical research, regulatory affairs and quality unit
Deployed environmental monitoring program for non-sterile production
Prepared three pre-IND meeting packages and various FDA and TPD submissions including investigator’s brochure, annual IND reports, safety reports, CMC, DMF and protocol amendments

Jan 1996 - Dec 1997

2 years

Implemented total quality system for company sites in Laval and Paris
Supervised QC laboratories and reviewed operating procedures for R&D, production, QC, packaging and shipping
Implemented quality assurance in production and updated regulatory requirement information (cGMP, FDA, HPB, EMA, ISO, ICH)
Conducted supplier and vendor system audits and monitored stability programs
Drafted and implemented processes and procedures including SOPs, control reports and order reception
Developed MRPII network for manufacturing planning
Provided in-house quality training and technical training for laboratory associates
Implemented microbiological surveillance, safety program and deviation management
Drafted metrology, equipment validation and control procedures and first edition of quality manual to achieve ISO certification

Jan 1995 - Dec 1996

2 years

Performed cGMP audits in sterile and non-sterile production
Investigated microbiological contamination events and proposed cGMP-compliant solutions
Controlled quality of in-process and finished products and planned laboratory stability tests
Conducted potency assays and microbiological controls including sterility, pathogen detection, total counts and pyrogen testing
Managed batch documentation and delivered cGMP training for sterile production staff

Jan 1991 - Dec 1995

5 years

Managed QA function in virology laboratory
Planned and performed assay validations and controlled quality of human antiviral vaccines
Maintained primary cell cultures and continuous cell lines and controlled serology of clinical trial test populations
Archived and filed QC documents
Implemented procedures for materials and equipment and prepared validation protocols and reports for viral inactivation and elimination techniques for EMA, FDA and WHO submissions
Trained technicians and students in virology techniques, conducted virus harvests and developed immunological titration methods (ELISA, RIA, sero-neutralization)
Participated in corporate total improvement team