PDA Texas Chapter: Contamination Control Strategy and Facility Tour

Featured Presenters

• 

  Stephen Beekman

  Quality Assurance Executive, Pfizer

  Read Bio

  

  Stephen Beekman

  Pfizer

  Stephen has over twenty-five (25) years of pharmaceutical and medical device compliance, audit, and inspection management experience which was derived from roles within global organizations and regulatory agencies. 

   Stephen is remotely based in Texas (Dallas/Fort Worth area) and joined Pfizer’s Inspection Readiness team in 2018 with the primary responsibility for supporting manufacturing sites during their preparation for regulatory agency inspections.  Prior to Pfizer, Stephen spent 13 years with Novartis/Alcon in various compliance and audit roles, and ten (10) years conducting GMP, GCP, and GLP inspections for the US FDA out of the Dallas District Office and The State of Texas.  

• 

  Taylor Chartier

  CEO, Modicus Prime

  Read Bio

  

  Taylor Chartier

  Modicus Prime

  Taylor Chartier is a former data scientist and engineer from the pharmaceutical industry. She has supported FDA Biologics License Applications by advancing Quality by Design initiatives in Process Development, Manufacturing Sciences and Technology, and Commercial Manufacturing operations. She has also applied machine learning and artificial intelligence for multivariate modeling to optimize pharmaceutical production and perform root cause analysis, most recently at Bayer Pharmaceuticals.  Her education consists of a 5-year accelerated bachelors and masters program in chemical engineering at the University of Rochester, NY, and she was most recently pursuing a PhD in applied AI with wearables research for Parkinson’s patients at the University of Luxembourg.  Chartier started the AI software company, Modicus Prime, to provide pharma with compliant AI computational techniques and apply them in a vigorous way to help safely and more efficiently produce drugs for patients.

• 

  Madison Hoal

  Ecolab Life Sciences

  Read Bio

  

  Madison Hoal

  Ecolab Life Sciences

  Madison is a pharmaceutical microbiologist who has experience in the manufacture of a range of pharmaceutical formats including non-sterile liquids, topicals, and parenteral drug products. Madison’s experience includes working with a team to design and qualify a clinical drug product manufacturing facility. She has experience developing an environmental monitoring program for an ISO classified aseptic manufacturing facility and established an on-site microbiology laboratory. She has also been responsible for site-wide aseptic operations, training, and gowning programs. Madison has led numerous investigations into environmental monitoring non-conformities, utilizing risk management to identify and mitigate contamination risks. She has implemented necessary changes to facility design, procedures, and personnel training to optimize the process and minimize contamination risks. She holds a BSc in Microbiology, is a IRCA accredited GMP provisional auditor, and is a member of the PDA and American Society for Microbiology.