Committee & Presenter Biographies

Fred, a 1999, graduate of Franklin College of Indiana with a Bachelor of Arts (B.A.) in Biology. While at Franklin College he was a 4-year student-athlete and participated in the institution's Leadership Program. After graduating, Fred spent time in the contract manufacturing industries, then joined Eli Lilly and Company in 2001. During his 20+ year career at Eli Lilly and Company, Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility to develop, implement, and continuously improve the site's sterility assurance programs. As a Global Advisor, Fred was responsible for ensuring Lilly Quality Standards and associated Sterility Assurance Programs evolve with global regulatory expectations. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter and contributor to PDA. He has been a PDA Midwest Chapter Board Member since 2014, serving as Chapter President from 2020-2021, and was recently nominated and selected to join the PDA Scientific Advisory Board.

With over 20 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality Operations for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for Quality Operations across five of Emergent's manufacturing sites across Canada, the US and Switzerland. Marcia is a Microbiology graduate from the University of Toronto and recently completed her MBA from Purdue University.

Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 11 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

Ms. Essex oversees Quality for Sanofi’s cell and gene therapy CMC unit. She was previously the recognized global expert in Microbiological Contamination Control for Biologics at Sanofi and is co-leading a new PDA technical report on Contamination Control Strategy for the pharmaceutical industry.

Ms. Essex has 17 years’ experience in Quality focused on Microbiological Contamination Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human cell systems. Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds two graduate degrees in Bioengineering and Stem Cell Medicine.

Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 20 years in the pharmaceutical industry, in various microbiology and management roles. 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 since 2000 and is presently serving on both the Science and ATMP Advisory Boards and is the co-chair of the Microbiology/EM Interest Group. Marc is a member of the Annex 1 Scientific Program Planning Committee and co-chairs the Microbial Data Deviation Investigations conference. He has chaired several Technical Reports and Points to Consider publications and is currently supporting PDA’s Asia Pacific and India Chapters at conferences and delivering local training courses.
In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA’s Training and Research Institute, where he has been a faculty member for more than 10 years. He has also developed the EM training course for the FDA’s Compounding Quality Center of Excellence.
Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.

David Keen is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing, both sterile and non-sterile dose forms, for FMCG, CMO and clinical trial manufacturing.

David is experienced in sterility assurance for dose forms ranging from bulk API to small molecule sterile injectables. He is experienced in both terminally sterilized and aseptic processes, non-sterile liquids, topical products, inhalations and more specialist dose forms such as radiopharma, vaccines and highly potents.

David’s experience includes dealing with regulatory inspections (MHRA, FDA, EMA, TGA etc), internal and external auditing. He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, SIP and moist heat failures. He works with technology ranging from high spec closed system isolators utilizing robotic technology to open cleanroom manufacturing in high risk fields such as ‘specials’ (compounding). In his current role David works with customers on devising the most efficient and robust cleanroom disinfection strategy. He also works with customers on their environmental monitoring programs, water systems and regulatory compliance.

Amanda McFarland 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, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program 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, the co-chair of the PDA Membership Advisory Committee (MAC) and co-chair of the PDA /ANSI standard on QRM in aseptic processing.

Tracy Moore is an accomplished quality professional with over 32-year experience of pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA) where she reached Expert Inspector level / status. During her 10 years as a GMP Inspector Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy has expertise across most dosage forms and in particular, sterile manufactured products produced aseptically for which she has presented on a range of topics associated with GMP Annex 1 and data integrity. Prior to joining the MHRA Inspectorate, Tracy spent 22 years working in both commercial and R&D environments of the pharmaceutical industry in various QA, QP and management roles covering a wide range of sterile and non-sterile product dosage forms. In addition to this she has been responsible for the audit and oversight of Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers.

Director Senior Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master in Pharmaceutical Microbiology form the University of Manchester

Don Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality. He was formerly a GSK Senior Fellow. Don has been Chair of the USP General Chapters - Microbiology Committee of Experts and a member since 2000. He is a Certified GMP Professional, a Certified Specialist Microbiologist and is a member of the European Pharmacopeia Group 1 Microbiology Committee. Don is also an adjunct professor in the Biopharmaceutical Quality graduate program at the University of Maryland Baltimore County. He was an author of the PDA Technical Report for “Contamination Control Strategy” along with two other technical reports, one for Pharmaceutical Package Integrity and one for Objectionable Microorganisms. Don’s career spans over 40 years of research and quality control.