Isabelle Hoenen PharmD Lilly France SAS

Isabelle Hoenen PharmD & Master in Industrial Microbiology / Currently Senior Quality Advisor for Sterility Assurance at Lilly France S.A.S 30 years of experience in aseptic production, in Lilly's quality and technical standards creation & update, involved in major site and global aseptic process & facilities design, control and monitoring projects, audits & inspections, investigations. Active member in several associations especially in the sub-groups or taskforces related to EU GMP Annex 1 related topics (A3P, EFPIA, LEEM, ECA, PDA, PHSS). Regular Speaker, congress moderator or Co-writter of different guidances : e.g. ECA & A3P CCS guidances, key TR document peer-reviewer or Pharmacopoeial drafts commenting groups member, etc... Current areas of focus : EUGMP Annex 1 Industrial hot Topics, CCS metrics performance evaluation, APS strategies, Local Flora Microbial Strains included in GPT pool