Deborah Havlik


Deborah Havlik has years of experience supporting the development of microbiological test methods and sterilization processes for drug products, biologics and combination products globally. Deborah has industry experience working in medical device, contract sterilization/contract laboratory and pharmaceutical companies. She has developed sterilization processes in ethylene oxide, moist heat, dry heat and radiation and also evaluated novel sterilization technologies and has successfully presented new testing approaches and sterilization processes to regulatory authorities. Deborah is active with the Parenteral Drug Association and with AAMI and ISO on multiple working groups developing sterilization standards.

Academic & Professional Qualifications:
  • BA, General Science, Chemistry Minor, University of Iowa
  • Expert Member, representing US on ISO WG3, Moist Heat Sterilization; WG8, Microbiological Methods; WG9, Aseptic Processing; Convenor; and WG14, Dry Heat Sterilization
  • AAMI Faculty, PDA Educator
Training, Quality Systems, & Specialties:
  • ISO 11135 Ethylene Oxide
  • ISO 11137 Radiation
  • ISO 11737 Microbiological Methods
  • ISO 20857 Dry Heat
  • ISO 14937 General Criteria, Sterilization
  • Global Regulatory Submissions