PDA Southeast Chapter

Redica Systems

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
STERIS Corporation

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, PhD
Quality CMC Consulting

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, M.S.
Valsource, LLC

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.

Crystal Booth
PSC Biotech

Crystal M. Booth, M.M., is a Senior Technical Director at PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and quality assurance. She obtained her master’s degree in microbiology from North Carolina State University. Crystal is a seasoned award winning technical writer and author of Method Development and Validation for the Pharmaceutical Microbiologist. During her career, Crystal has worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories. Crystal has developed and validated numerous microbial methods and has worked with many different product types.

Michelle Dennis
MilliporeSigma

Michelle Dennis joined MilliporeSigma in May of 2015, and has been the QC Microbiology specialist in NC for the last 5 years. She is responsible for supporting pharmaceutical microbiology laboratories within North Carolina on their methods for sterility, bioburden testing, environmental monitoring and pyrogen testing. She works closely with QC Microbiology lab managers and their teams in NC and enjoys identifying areas where she can simultaneously enhance efficiency and compliance in the lab and establish partnerships between the client and vendor. Michelle received her Bachelors of Science in Microbiology from the University of Maryland, College Park in 2006. Michelle has found the PDA to be very helpful in her career, and she enjoys connecting microbiologists that are not currently aware of the PDA to its’ resources and community. She shares PDA news and events with those within the industry, and sees huge opportunity for engagement among pharmaceutical microbiologists in NC. Continued education, shared best practices, mentorship, and diversity within our field are important principles that Michelle can help contribute to as a Board Member-at-Large.

Nathan Blazei
Kymanoz

Nathan Blazei is the Head of Quality & Regulatory Affairs at Kymanox, a life science consulting firm serving clients on their mission of bringing modern medicine to patients in need. Nathan leverages his 20 years of experience in the life sciences to provide optimized solutions to clients with respect to innovation, product quality, and patient safety. Today he specializes in quality management system development and optimization, outsourced quality oversight, regulatory pathway assessments, regulatory body inspection readiness, marketing authorization submissions, auditing, gap assessments, and risk management programs. He has presented at industry events on various topics relevant to the life sciences, and he continues to offer training internally and externally to share best practices, lessons learned, and new approaches to old problems. As a member of PDA for many years, Nathan has enjoyed the information exchange with fellow life science professionals and wants to build a more collaborative environment in the Southeast Region so that the industry as a whole can benefit from each other's knowledge and experiences. Previously, Nathan held technical roles at Liquidia, Novartis Vaccines & Diagnostics, Grifols/Talecris Biotherapeutics, ev3, and Boston Scientific. Nathan has a Bachelor of Science degree in Chemical Engineering from the University of Notre Dame and a Master of Engineering degree in Bioengineering from the University of California, San Diego. He is a Certified Quality Auditor (CQA) through the American Society for Quality and holds a Regulatory Affairs Certification (RAC-US) through the Regulatory Affairs Professionals Society.