BioPhia Consulting Inc.
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Edwin Moore
Richard Johnson
Bruce Riser
Shelley Maves
Deborah Rice
Edward Chess
David LeBlond
M. R. Azari
Charlene Stubbs
Jeffrey Staecker
Robin Geller
Robert Lang
Steven Laurenz
James DiOrio
Barrett Rabinow
Kimberly Rohn

 

      Kimberly Rohn  

Expertise: Quality System design, optimization and compliance for pharmaceutical, biotechnology and combination products.  Incremental Quality System development for start-up and new healthcare services e.g., preparation for phase 1/clinical use, specialty and homecare pharmaceuticals, compounding/outsourcing facilities.  Planning for evolution from developmental > Preclinical/GLP > Clinical/GCP/GMP > Commercialization/GMP/Post Marketing Commitments.  Remediation planning and compliance implementation for API, Finished Products and Data Integrity.  Sterile product, Aseptic Manufacturing and Sterility Assurance   

 

Experience: Sterilization microbiology roots; Alternate Site Therapy Quality Assurance leadership (Home care pharmacy, compounding/outsourcing facilities); Established and led Baxter Hemoglobin Therapeutics Quality System and Organization.  US and Global Quality Systems and Compliance leadership at TAP/Takeda Pharmaceuticals.  

 

OtherParenteral Drug Association (PDA), YWCA Woman of Achievement in Business Award, Planning Committee for the Great Lakes cGMP & Regulatory Science Forum, Northwestern University Biotech Masters Program Speaker 

email Kimberly Rohn            complete CV

 

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