PDA Southeast Chapter: Spring Conference

Featured Presenters

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  Kristen L Anderson, PhD

  Microbiologist, ONADE, CVM, U.S. FDA

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  Kristen L Anderson, PhD

  U.S. FDA

  Kristen Anderson, PhD, is a Microbiologist with the U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, in the Division of Manufacturing Technologies. She is responsible for the review of the chemistry, manufacturing, and controls information for sterile injectable animal drug products and is recognized as an expert in the area of sterile process validation. She currently represents CVM on the Parenteral Drug Association (PDA) BSRPDA Standard for Quality Risk Management of Aseptic Processes.
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  Frederic B. Ayers

  ValSource, Inc.

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  Frederic B. Ayers

  ValSource, Inc.

  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, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. 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 global Sterility Assurance Subject Matter Expert. For Lilly–Indianapolis Parenteral Manufacturing, he had the responsibility of the development, implementation, and continuous improvement for all aspects of the site's sterility assurance program. As an Advisor for the Global Quality Standards organization, Fred was responsible for ensuring that Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations. Currently, Fred provides consultation services to the pharmaceutical and biopharmaceutical industries, specializing in Contamination Control, Sterility Assurance, and Microbiology. 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 of PDA has a Board Member since 2014 (President from 2020-2021) including a Task Force Member for PDA Technical Report 90. Fred is a committee member for many workshops and conferences, and a standing member of the PDA Scientific Advisory Board.
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  Katie Bevard

  Quality Systems Senior Specialist, Amgen

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  Ilona Endisch

  Associate Director, Product Innovations, Novatek International

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  Ilona Endisch

  Novatek International

  Ilona Endisch, BCompSc., is the Associate Director of Product Innovations for North America at Novatek International. Ilona has over 12 years of experience in the Pharmaceutical/Biotech software industry in areas of software innovation and applications, global account management and business strategy & development. In her current role, Ilona works with customers world-wide to assist in their URS and process mapping of environmental monitoring and other software and helps to identify new product innovations. Ilona is active in the industry, giving presentations and performing trainings in topics related to software, microbiology, quality management, risk assessment, and other areas. Ilona has a Bachelors in Computer Science from Concordia University in Montreal, Canada.

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  Eamon Fitzmaurice

  Chief Financial Officer, Civica Rx

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  Emily Heffernan, PE

  DPS Group

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  Emily Heffernan, PE

  DPS Group

  Emily Heffernan, US Director New Process Technologies, is a process Subject Matter Expert (SME), specializing in biological process and facility design. Working in the life sciences for 20 years, she has gained expertise in designing facilities for monoclonal antibodies, vaccines, and novel therapies including cell and gene therapy production. She is industry-recognized for her subject matter expertise in multi-modal facilities where different product types are produced in the same facility, due to her deep knowledge of complex facility layouts, GMP flows, and regulatory considerations.

  A graduate of North Carolina State University, Emily holds two degrees: a Bachelor of Science in chemical engineering and Bachelor of Science in biochemistry. She is also a licensed Professional Engineer in the state of North Carolina and an active member of the International Society of Pharmaceutical Engineers (ISPE).

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  Erin Hill

  Executive Director of Logistics and Supply Chain, Eli Lilly & Company

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  Madison Hoal

  Ecolab Life Sciences

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  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.

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  Ryan Murray, MS

  Senior Consultant, ValSource, Inc.

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  Ryan Murray, MS

  ValSource, Inc.

  Ryan Murray is a quality and manufacturing science Senior Consultant with ValSource, Inc. He is primarily focused in the areas of quality and regulatory compliance, facility design and control, technology transfer, process qualification, and aseptic risk management of both biologics and advanced therapy medicinal products (ATMPs). Ryan is an active member of the Parenteral Drug Associationand the International Society for Pharmaceutical Engineering (ISPE). He has a BS in biomedical science and MS in biochemistry and biophysics from Texas A&M University.
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  Dawn Nestola

  Director Sterility Assurance and Microbiological Quality, GSK

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  Dawn Nestola

  GSK

  Dawn is an accomplished global leader with diverse technical experience and strong interpersonal skills. Twenty + years of experience focused on infection prevention through microbiological quality and sterility assurance in the development and manufacture of medical devices, aseptically-produced pharmaceutical, biotechnology, and consumer healthcare products.

  Dawn's Technical competencies include Aseptic Processing, Manufacturing Microbiological Process Controls, Ethylene Oxide Sterilization and Medical Device Reprocessing.

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  Lisa Winstead

  Senior Director - Site Quality Head, Resilience