In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs. He has been an active PDA member for over 25 years and is presently serving on the Board of Directors and on the planning committee for the PDA/FDA Joint Regulatory Conference. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and served on both the Science and ATMP Advisory Boards and the former co-chair of the Microbiology/EM Interest Group. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.

McFarland is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, and Kilmer Regulatory Science Collaboration co-lead. She has a B.S. in entomology and an M.S. in mycology, both from the University of Florida.

As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. Fred is currently an industry consultant to the pharmaceutical and biopharmaceutical industries, specializing in Contamination Control, Microbiology, and Sterility Assurance. Fred has been a strong supporter of PDA (Midwest Chapter President from 2020-2021) including a committee member for many workshops and conferences, Task Force Member for PDA Technical Report 90, and a member of the PDA Scientific Advisory Board.

Stephen is currently a Director in Global Quality – Microbial Control and Sterility Assurance at Merck & Co. and is an expert in aseptic processing and pharmaceutical manufacturing microbial control.

Don is a member of the European Pharmacopeia Group 1 Microbiology Committee and was a 22 year member of the USP Microbiology Expert Committee. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and is a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans 40 years of research, quality control and quality assurance in the pharmaceutical, cosmetic, and food industries.

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 qualification programs.

David’s experience includes overseeing environmental monitoring programs for both aseptic fill finish and terminal sterilization facilities, as well as performing quality control testing of raw materials, in-process, and finished products. He has experience developing cleanroom qualification sampling plans and identifying trends within EM data to drive continuous improvement. David has also overseen site-wide gowning qualification programs and led various trainings on aseptic operations. He has led numerous investigations into environmental monitoring non-conformities utilizing risk management to identify and mitigate contamination risks.