Véronique Dagois

Expert Biochemical Engineer

Profile

50 years old

Seniority : 2 years, associate

English

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

Former member of the SOFAQ commission on quality assurance for electronic signature and data (US regulation: 21 CRF PART 11)

Education

DESS postgraduate degree 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 records – electronic signature)

Quality Department, French affiliate
Quality Engineer managing products launching, audits and subcontractors for generic products

Corporate Regulatory Affairs – Europe
Regulatory Project Manager for registered products according to European (centralised, 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 using chromatographic methods (HPLC and TLC)

BOSTIK (formerly DOITTAU EMULDO)
Analytics Project Manager

ROCHE
Analytics Project Manager

Key areas of expertise

Pharmaceutical industry – Medical devices

  • Design error
  • Preclinical and clinical evaluation error
  • Cross-contamination and microbial contamination
  • Under- or over-dosage of active ingredient
  • Container/content interactions
  • Drug counterfeiting
  • Degradation of finished products, active ingredient, raw and packaging materials
  • Secondary packaging error (box, patient information leaflet, label) or primary packaging error (blister, vial, bottle, sachet, etc.)
  • Adverse effects monitoring error (pharmacology or materials vigilance)
  • Loss or corruption of electronic and paper-data
  • Marketing error

Cosmetics – Food supplements

  • Formulation error
  • Degradation of finished products, active ingredient, raw materials and packaging goods
  • Contamination by external agents
  • Container/content interactions
  • Packaging error

Analytical chemistry and fine chemicals

  • Error in physical/chemical, microbiological and medical analyses
  • Concrete corrosion
  • Defective plastic parts (cosmetics, etc.)
  • Medical and paramedical packaging: vials, glass bottles
  • Issues with inks, glues and adhesives on different surfaces
  • Error in the manufacturing of essential oils, fragrances, flavours and dyes

Biochemistry – Biotechnologies

  • Biomass (biofuels and bioenergy)
  • Water treatment (disinfection, pool, waste water treatment plant, etc.)
  • Waste treatment (bacterial degradation, methanisation, etc.)
  • Manufacture of food products by fermentation

Regulatory computerised systems (traceability, confidentiality, regulation)

  • Failure to identify and formalise user requirements
  • Discrepancy between the functional specifications and user requirements
  • Discrepancy between the functional specifications and the regulatory rules of the business (electronic signature, personal data, traceability, confidentiality, regulation, etc.)
  • Partial or total data loss (overwriting or loss of server hosted data, etc.)
  • Service interruption due to material or immaterial damage (disk crash, fire, water damage, natural disaster, etc.)