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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  Katie Bevard

  Amgen

  Katie Bevard is a Quality Systems Senior Specialist at Amgen Inc., a leading biotechnology company. She has over 18 years of experience in quality control, product quality, and regulatory intelligence. She is responsible for evaluating and managing regulatory intelligence to ensure compliance with new and updated regulations, collaborating with global teams, and supporting inspections. She is also a subject matter expert in overlay chromatogram and stability programs. Katie has experience in enhancing processes, developing metrics, and technical writing. She enjoys collaborating with diverse groups internally and externally to her organization. 

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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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  Eamon Fitzmaurice

  Civica Rx

  Chief Financial Officer Eamon Fitzmaurice joined Civica from Novartis Gene Therapies (previously named AveXis) where he served as Controller, Global Technical Operations shortly after joining the company as Plant Controller in 2018. Prior to Novartis, he was Plant Manager for two years at a Purdue Pharma Oral Solid Dosage facility.

   Eamon previously worked at Novartis Vaccines where he led the U.S./global vaccine finance organization through the sale of Novartis Vaccines to GlaxoSmithKline (GSK), including through the deal closure and integration with CSL. Prior to Novartis Vaccines, he spent 23 years with Merck in Finance and Operations (Production & Operational Excellence). Eamon holds a B. Commerce from University College Cork, Ireland and a CMA from the Chartered Institute of Management Accountants in London, UK.

   

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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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  Erin Hill

  Eli Lilly & Company

  Erin Hill is presently the Executive Director of Logistics and Supply Chain at the Lilly Research Triangle Park site. She has led the start up of supply chain and logistics operations at through multiple facility start-ups including a biologic, gene therapy and device assembly manufacturing facilities. She currently led the start up of a complex logistics operation including a multi node warehouse operation, central logistics warehouse, and an integrated intralogistics system for the Lilly RTP site.

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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’s 24-year career as a microbiologist has been focused on infection prevention through microbiological quality and sterility assurance.  She is experienced in contamination control related to the manufacture of sterile, low bioburden and non-sterile products, medical device development and associated clinical processing, and medical device sterilization.  

  Dawn presently works for GSK as Director of Sterility Assurance & Micriobiological Quality.  Prior industry experience includes positions with Johnson & Johnson (McNeil and DePuy Synthes), Pfizer, and Pharmacia.  She also enjoyed time as an adjunct professor teaching an accredited college level course on the fundamentals of aseptic processing.  Dawn earned a Bachelor of Science degree in Microbiology from Michigan State University and holds a Master of Business Administration degree from Centenary University.   

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  Shwetha Ravi Devine

  Lead Process Engineer, Arcadis DPS Group, Inc.

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  Shwetha Ravi Devine

  Arcadis DPS Group, Inc.

  Shwetha Ravi Devine, Lead Process Engineer at Arcadis DPS Group has over 14 years of process and project engineering experience in biological process and facility design, with expertise that spans over multiple therapeutic areas, including monoclonal antibodies, cell and gene therapeutics, oligonucleotides, integrated continuous bioprocessing, and single-use technology.

  In her current role, Shwetha works with biopharmaceutical companies to bring new and emerging life science technologies to market. With a Master’s in Biotechnology and hands-on experience in process development and manufacturing, Shwetha brings a unique perspective to the table in all her projects.  

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  David Turner

  Global Technical Consultant, Ecolab

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  David Turner

  Ecolab

  David is a pharmaceutical microbiologist with 10+ years of experience in the manufacture of various pharmaceutical formats including oral liquids, topicals, sterile inhalations, and sterile injectables. 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. 

  David is a Global Technical Consultant with Ecolab and advises on correct application and use of cleanroom biocides to meet current regulatory guidance and industry best practice. He specializes in the implementation and optimization of cleaning and disinfection regimes.

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  Lisa Winstead

  Site Quality Head, Resilience

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  Lisa Winstead

  Resilience

  Lisa Winstead is currently the Site Quality Head at Resilience Inc in Durham, NC. Lisa has acted as a leader of the sterility assurance and quality programs. Lisa has experience in building and managing large teams, developing, and deploying standard operating procedures and guidelines, and expertly maintaining businesses processes. She had supported GMP manufacturing, Sterility Assurance initiatives and has ensured compliance by managing the release of bulk and filled Product. Prior to her current role at the Resilience Durham site, Lisa held various leadership positions at Hospira, Pfizer, Wyeth and Human Genome Sciences.

  Lisa has more than 25 years of industry experience which expands to quality management, GMP auditing, root cause analysis, CAPA verification, Quality Risk Management, GMP operations, Inspection Readiness, Product Approvals, and batch disposition. She has made significant contributions in driving operational excellence and achieving superior results regarding batch manufacturing cycle times. Lisa has consistently turned around organizations with compliance challenges. Lisa has demonstrated success in implementing Quality Management programs, Data Integrity Remediation, Product Licensure Approvals, Maturity Modeling, improving lead times and implementing remediation activities that meet regulatory requirements.

  Lisa holds a B.S. degree in Biology from Saint Paul’s College, an MBA in Management from Iona College and a Master in Regulatory Science from the University of Maryland. She is also a certified Quality Auditor by the American Society of Quality and a Certified Qualified Person Liaison by David Begg & Associates.