PDA Southeast Chapter

Chapter Officers

• 
  Austin Caudle

  President

  Redica Systems

  [email protected]

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  Austin Caudle, MSc, MRQA is a Senior Enterprise Sales Executive with Redica Systems, a software company that provides regulatory and compliance data intelligence to Quality & regulatory experts around the world. He has over 20 years of experience as a business leader accelerating growth, profitability, and value in the highly competitive biotech, pharma, and medical device markets. His industry experience spans the many facilities and processes necessary to bring a drug/biologic/device to market – from the laboratory and R&D through manufacturing. Prior to joining Redica Systems, Austin served as a SME at Kelly Science & Clinical and held positions at Fortune 500 companies, IQVIA and ThermoFisher Scientific, and leadership roles at NSF Health Sciences and Charles River.

  Mr. Caudle studied Nutrition and Food Science at Auburn University in Auburn, Alabama USA. He holds a BSc in Nutrition and Food Science and an MSc in Food Science and is published in several scientific journals for academic research. Austin has served on the Southeast Chapter Board of Directors, participated in multiple program planning committees as a contributor/moderator, an author/contributor to the PDA Letter, and was recognized as a leader in the Volunteer Spotlight with the Parenteral Drug Association (PDA), an invited speaker on AI and Data Science in Next Generation Clinical Development at the Precision Medicine World Conference (PMWC), and twice served as Co-Chair for the International Pharmaceutical Excipients Council (IPEC) World Conference Planning Committee. He is a member of PDA, ISPE, AAPS, RAPS, and RQA professional associations.

• 
  Casey Poirier

  President-Elect

  STERIS Corporation

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  Casey Bailey Poirier is a North Carolina native and an Account Manager with STERIS Corporation Life Sciences Division. Her current responsibilities include providing contamination control solutions related to disinfection, process cleaning, and sterility assurance for the biotech, pharmaceutical, and medical device industries. Casey leverages over 12 years of experience in QC Chemistry, QC Microbiology, and Validation roles. Prior to joining STERIS, she served as a Lead Validation Engineer for Stallergenes Greer where she oversaw the site process simulation program, led projects to continuously improve validation and quality system programs, and enhance equipment performance capabilities. During her tenure as a validation professional, she became well versed with PDA Technical Reports as a guideline for compliance during these initiatives. She earned a Bachelor of Science in Biology at Wingate University and Master of Business Administration in Project Management. In addition, she holds Lean Six Sigma Green Belt Certification from University of North Carolina at Charlotte.
• 
  Jessica Blomberg

  Secretary

  Quality CMC Consulting

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  Jessica Blomberg owns Quality CMC Consulting, a pharmaceutical development consulting company, focusing on delivering flexible and phase appropriate support to emerging and established Biotech/Pharma/Medical device clients, and empowering compliant and science driven decisions that are right first time. She assists clients with due diligence M&A activities and virtual company design and function. She was named 2020 Triangle Business Journal Life Science Consultant of the Year. Selected clients include Chiesi USA, HemoShear Therapeutics, Icosavax, Locus Biosciences, Notable Labs, Roivant, and Activated Research Company as a strategic advisor. Prior to starting Quality CMC Consulting in Dec-2012, she worked for small-to-mid sized companies in RTP, NC: Erimos (Pharmaceutical Development), Inspire (Sterile Manufacturing) and BioCryst (QA). During this time for seven years, she was on the executive committee serving as Past-Chair, Chair, Co-Chair, Secretary, and Treasurer for the non-profit NC Discussion Group of AAPS. Jessica received her Ph.D. in Analytical Chemistry from Duke University in 2003, is a Board Member of the Astronaut Scholarship Foundation, and a PDA member since 2012. She is the co-inventor of multiple patents and provides training to the industry.
• 
  Amanda Bishop McFarland

  Treasurer

  Valsource, LLC

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  Amanda is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, contamination control strategies, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate risk management program within a multi-national company by developing the procedures required and training the organization in the execution of consistent risk management tools. Ms. McFarland currently serves as the PDA QRM interest group co-lead, PDA Membership Advisory Committee (MAC) co-chair, PDA QRM/Aseptic processing co-chair and a faculty member of the Quality Risk Management Certificate Training Series at PDA training institute.