Expertise in Quality and Regulatory Affairs
- Filing DMFs since 1988.
- Founding Member of the GMP
Working Group of CEFIC APIC,
member since 1994, involved in the
development of industry
best practice documents (e.g. CEFIC / EFPIA GMP
Guide which
was one of the baseline documents for ICH Q7A, Cleaning
Validation Guidance, ICH Q7A How to Do Document, Qualification
of Existing
Equipment, etc.)
- Passing successfully FDA
inspections since 1988
- Acting as speaker on GMP
Conferences
- Active member of the Planning Committee for Q7A
conferences
organized by PDA, presented by the ICH Q7A expert working
group
members (European Tour in 2002)