Véronique Dagois

Expert Biochemical Engineer

Profile

51 years old

Seniority : 3 years, associate

English

  • Drugs products and medical devices
  • Cosmetic products and food supplements
  • Chemistry
  • Biochemistry
  • Biotechnology
  • Computerized systems in regulated production

President of the SFSTP Commission on Data Integrity (EU and US regulations)
Member of CYAN Network on Cybercrime
Former member of the SOFAQ commission on quality assurance for electronic signature and electronic data (US regulation: 21 CRF PART 11)

Education

DESS Master in Quality Assurance – option production
Université François Rabelais Tours

BTS diploma in Biochemistry
Lycée Raoul Dautry Limoges

Professional background

SANOFI

Global Quality Audit
Global Quality Auditor for the validation of the computerized system (Loss and corruption of electronic datas – electronic signature – personal data – infrastructures – validation)

Quality Department, French affiliate
Quality Engineer managing the launch of the generics drug products, the audits of subcontractors and the validations of the computerized systems

Corporate Regulatory Affairs – Europe
Regulatory Project Manager of drug products registered by European (centralized, MRP, DCP) and national procedures

Preclinical Quality Assurance (R&D)
Quality Engineer for the toxicology, pharmacokinetic and safety pharmacology Departments (animal testing – preclinical studies)

Analytical Department (R&D)
Analytics Project Manager in charge of the validation, forced degradation and stability of active ingredients by chromatographic methods (HPLC and TLC)

BOSTIK (formerly DOITTAU EMULDO)
Analytics Project Manager

ROCHE
Analytics Project Manager

Key areas of expertise

Pharmaceutical products – Medical devices – Food supplements

  • Design defect
  • Cross and microbiological contamination
  • Under and over-dosage of the active ingredients
  • Degradation of the drug products (stability studies)
  • Quality defect of active ingredients and packaging items
  • Batch recall
  • Site closure following some injunctions of the Health Authorities

Cosmetics – Perfums – essential oils

  • Error in formulating of a product
  • Contamination by external agents
  • Packaging error
  • Quality defect of raw materials and packaging items
  • Batch recall

Analytical chemistry

  • Error in physical, chemical, microbiological and medical analyses
  • Contamination of essential oils, raw materials, perfumes, flavors, dyes, lamination and food products
  • Non-compliance of the packaging items

Computerized systems

  • Deficiency in the identification and the formalization of user’s requirements
  • Functional inadequacy of the software with the user’s requirements
  • Alteration and loss of electronic data
  • Service interruption resulting in damage immaterial (operating losses…)
  • Error on the management of the personal data (CNIL)

Prevention

  • Regulatory Audits in the Life Science Sector
  • Advices and trainings on the compliance with pharmaceutical regulations (production, distribution, clinical, preclinical, computerized systems, pharmacovigilance, data integrity).
  • Advices and trainings on the compliance with the GDPR/RGPD ( personal data)
  • Validation of the computerized systems