Shadle Consulting Services
Good Science is Good Compliance
::  Presentations  ::
We regularly present at various meetings; we participate to stay current with industry and regulatory trends.
Paula Shadle, Ph.D.
  • Course director and speaker for professional continuing education at the University of Wisconsin, Dept of Engineering, Parenteral Drug Association (PDA), IBC (International Biological Conferences), Ohlone College, and direct-to-customer.
  • Topics include:
    • Quality Systems
    • Inspection Readiness
    • Writing Technical Reports and GMP Investigations
    • Cleaning Validation
    • Stability Testing
    • Batch Production Records
    • Raw Materials Control
    • Corrective And Preventive Actions - CAPA
    • Effective OOS Investigations
    • Biopharmaceutical Process Development And Others.
  • Contributor and editor for:  Guide to Bioterminology, 2nd Edition, International BioPharm, August 2006.
  • Lecturer in courses offered by the International Pharmaceutical Academy, Toronto, Canada, including:  Preparation for Pre-approval Inspections; Quality Systems.
  • Complete list available upon request.
Ann Daus
  • University of Wisconsin Engineering Professional Development, September, 2007, Evaluating Raw Materials for the Development of Biopharmaceutical Products