PDA Midwest Chapter: 16th Annual Microbial Contamination and Control Conference

Featured Presenters

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  Josh Eaton, MS

  Senior Director, Scientific and Regulatory Affairs, PDA

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  Josh Eaton, MS

  PDA

  Josh Eaton joined PDA in 2011 as a project manager and is now Senior Director, Scientific and Regulatory Affairs at PDA. He and his team work with PDA members to produce Technical Reports, Points to Consider documents, and feedback on regulatory draft guidance. The S&RA staff also facilitate the activities of the PDA Technical Advisory Boards and PDA Interest Groups. Prior to joining PDA, Josh developed and marketed drug discovery and research reagents and co-founded a small spin-off company based on those technologies. He earned his Master’s degree in Biochemistry and Biotechnology in 2005 from Georgetown University.
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  Gordon Ely

  Senior Project Manager, LexaMed

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  Gordon Ely

  LexaMed

  Gordon E. has over 30 years of experience in the medical device, pharmaceutical, biologics and compounding pharmacy industries. Gordon began their career in 1990 as a Laboratory Technician at Nelson Laboratories, Inc., where they were promoted to Associate Study Director and then to Study Director. Gordon then became the Bioburden Section Leader, QC/Validation Manager and IDs and Packaging Section Leader. In 2008, Gordon E. joined WuXi AppTec as a Senior Technical Specialist and Director of Microbial Assays and Specialized Studies, and later as the Director of Microbiology Operations. From 2016 to 2019, they worked at MiMedx as the QE Group Lead and Regulatory Affairs Manager. In 2019, Gordon E. became the President of GEM Consulting, providing consulting services in the areas of sterility assurance, contamination control, cleanrooms, microbiology, packaging, validations and other quality aspects. Gordon currently holds the role of Chairperson ISO/TC 209 - Cleanrooms and Controlled Environments at ISO - International Organization for Standardization.

  Gordon E. completed their secondary education at University High School from 1982 to 1985. Gordon then attended Brigham Young University from 1985 to 1995, where they earned a Bachelor of Science in Microbiology, General. Gordon has also obtained certifications from CALISO (ISO 13485:2016 Lead Auditor, obtained in January 2020), ASQ (Certified Quality Auditor), and the National Registry of Certified Microbiologists (Registered Microbiologist and Specialist Microbiologist).

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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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  Patricia Igneczi

  Andelyn Biosciences

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  Owen Jamison

  Eli Lilly and Company

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  Owen Jamison

  Eli Lilly and Company

  Owen Jamison is a Quality Control Biologist for Eli Lilly & Company supporting parenteral manufacturing in Indianapolis, Indiana. He has 7 yeas of GMP experience working on the benchtop in both microbiology and chemistry laboratories, with a focus on the bacterial endotoxin test (BET) and bioassays. In his current role Owen provides subject matter expertise for the QC microbiology department in the areas of BET, complex deviation investigations, and change controls. He holds a Bachelor of Science degree in Chemistry from Purdue University.

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  Michele LaBeau

  Senior Quality Manager, Baxter International

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  Aaron Mertens

  Senior Manager, Technical Services, STERIS Corporation

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  Aaron Mertens

  STERIS Corporation

  Aaron has over 24 years of experience in pharmaceutical manufacturing, with expertise in cleaning, disinfection, sterilization and contamination control. He has held several positions within the pharmaceutical industry, with experience working at pharmaceutical manufacturing organizations representing quality assurance programs and working with global industry regulatory agencies. He holds a bachelor’s degree in genetics. At STERIS Life Sciences, Aaron performs global manufacturing site evaluations and consultations to ensure compliance with international regulations. He is also responsible for providing global technical support for critical environments, sterility assurance and sterility maintenance application and validation. Aaron is an active member of the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE). He previously served as President of the ISPE Great Lakes Chapter and is currently on the chapter’s Board of Directors. He is also a member of the ISPE Sterile Products Processing Steering Committee. Additional professional activities for Aaron include delivering technical content to the industry with posters, publications, virtual and live technical presentations, as well as leading global sterilization master classes.
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  Dominique Newberry

  Scientist, Bristol Myers Squibb

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  Dominique Newberry

  Bristol Myers Squibb

  Dominique Newberry is a Scientist at Bristol Myers Squibb, in the Microbiology Center of Excellence, where she is the Endotoxin Lead. She holds a degree in Biological Sciences from Rowan University. Dominique has supported multiple endotoxin method verifications and various hold time studies. She demonstrates passion, accountability, and urgency in her work and is currently working to implement new technologies for sterility and endotoxin. With her love for animals, she strives to implement more sustainable methods for endotoxin testing across the BMS network. When not working in the lab, she demonstrates her love for animals and volunteers at a farm and also enjoys spending her time with family.
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  Paula Peacos, M.S.

  Senior Consultant, ValSource, Inc.

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  Paula Peacos, M.S.

  ValSource, Inc.

  Paula Peacos brings 30 years of practical industry experience as a Microbiologist. She has worked in contract manufacturing and testing organizations as well as small, mid-size and large pharmaceutical organizations.

  Paula possesses extensive experience in aseptic processing, biological API/drug substance manufacturing, cell and gene therapies and nonsterile production, both clinical and commercial, as well as microbiological laboratory management.

  She has also conducted numerous compliance audits internationally as a microbiological subject matter expert. She is an experienced trainer and has developed and implemented creative, customized developmental and remedial programs both in the US and abroad.

  In recent years, Paula has published a number of articles, conducted technical webinars and presented at major industry meetings on topics such as data integrity, using contamination rates for trending analysis, designing and implementing robust environmental monitoring and trending programs and performing successful root cause analyses, among others.

  Paula is currently employed as a Senior Consultant and Microbiological Subject Matter Expert at ValSource, Inc. She can be contacted at ppeacos@valsource.com.

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  Stacey N. Ramsey, MS, SM(NRCM)

  Charles River Laboratories

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  Stacey N. Ramsey, MS, SM(NRCM)

  Charles River Laboratories

  Stacey Ramsey is a QC microbiologist with more than 15 years of direct laboratory experience in pharmaceutical quality control. Through her years of method and process development, Stacey focuses to bring robust quality processes to the laboratory through continual improvement and change in order to deliver safe and effective products to patients. She received her Bachelor of Science and Master of Science degrees in Wichita, Kansas, and began her career in QC microbiology in parenteral contract manufacturing in McPherson, KS. Having worked in both contract manufacturing and laboratory services, she has a broad background in laboratory testing, including environmental monitoring, microbial identification, endotoxin testing, and rapid detection. Stacey is currently based out of Charleston, South Carolina, working for the Microbial Solutions division of Charles River Labs.

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  Dawn M. Watson

  Merck & Co., Inc.

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  Dawn M. Watson

  Merck & Co., Inc.

  Dawn is a Global Quality Assurance Director at Merck & Co., Inc., Rahway, NJ, USA. She works in Microbial Quality & Sterility Assurance managing a team that leads and executes global initiatives targeted to proactively address quality and compliance risks in the sterile and low bioburden network while driving continuous improvement. Additionally, her team provides microbial contamination control and sterile manufacturing expertise to resolve critical production issues, develop innovative solutions, and ensure network alignment with industry and regulatory expectations. She is an active member in the Parenteral Drug Association and BioPhorum Operations Group. She has 28 years of experience in the pharmaceutical industry, specifically focused on sterile and low bioburden products including vaccines, therapeutic proteins and small molecules. She is trained and certified in Six Sigma and Change Management. She has held positions in validation, manufacturing, technical operations and research and development throughout her career with Merck.