Agenda

Faculty

• Katherine Giacoletti - Partner, SynoloStats LLC

  
  Katherine has worked as a statistician in the Pharmaceutical industry for over 17 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics from North Carolina State University, with a focus in biostatistics. Katherine lives and works in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.

• Kim Huynh-Ba - Executive Director, Pharmalytik

  
  Kim is an accomplished author and speaker of the compliance and quality areas, both domestic and internationally. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010) published by Springer. She is currently working on a manuscript of “Analytical Chemistry: an introduction to pharmaceutical analysis,” expecting to be available late 2018. She can be contacted at kim.huynhba@pharmalytik.com.

• Steven S. Kuwahara, Ph.D - Principal Consultant, GXP BioTechnology, LLC

  
  Steven S. Kuwahara, Ph.D., is principal consultant at GXP BioTechnology, LLC (www.gxpbiotech.org) in Sunnyvale, CA. Steve has more than 30 years experience supervising quality control department dealing with drugs, biologics, HCT/P, and nutraceuticals. He has supervised animal facilities and testing laboratories that operated under GLP rules and also those operating under GMP and ISO standards. He may be reached by e-mail and by phone at 408-530-9338.

• Chris Latoz - Manager Stability and Analytical Services, Hollister Incorporated

  
  Christopher (Chris) V. Latoz is Manager, Stability and Analytical Services at Hollister Incorporated in Libertyville, IL. Chris has over 25 years’ experience in the medical device industry (Class I and II devices) working in R&D, Technical Services, and more recently, Stability. While at Hollister, Chris has led several process and capacity improvement projects, including: the implementation of a LIMS (Laboratory Information Management System) for stability sample and data management; the construction of new walk-in stability storage chambers; and the implementation of a temperature and humidity monitoring system for stability chambers.

• Jian Liu, Ph.D. - Stability Manager, Abbott

  
  Dr. Liu currently is a manager of stability department in the Analytical Chemistry Research and Technology of Abbott Vascular. Dr. Liu has over 20 years of extensive experience of analytical chemistry and stability program in the pharmaceutical and medical device industry. His pharmaceutical industry experience at Watson Pharmaceuticals focused on analytical chemistry for solid dosage products. Dr. Liu’s medical device industry career at Abbott Vascular (formally Guidant) started in analytical method development, validation and transfer for Drug Eluting Stents (DES) products.

• Carmen Medina, MPH, PhD© - VP Technical Services, PAREXEL International

  
  Ms. Medina uses over 30 years of FDA experience to support an array of international clients in their preparations for successful Pre-approval, GMP, GCP and combo-device inspections. She was a former Commissioned Officer in the United States Public Health Service and a PAI Investigator with the FDA, where she led an international group within Team Biologics and helped usher in the new medical device QSR regulations. Over the past 28 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands and bio-generics. See her textbook on Amazon: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics.

• Bette Monnot-Chase - Director, CMC & Quality, Asklepion Pharmaceuticals

  
  Bette has a strong background in drug development in the areas of analytical method development, stability, formulation, validation, and vendor management. Her main responsibilities included stability, product development and associated analytical testing, as well as preparation of regulatory CMC documents for global filings. Working for small Pharma that adopted a virtual model - outsourcing all CMC activities to third party vendors, Bette has extensive experience managing the need of her projects and the vendor’s needs, which is necessary to delivery high quality analytical methods, robust formulation and critical stability data to support the product in a global clinical or commercial marketplace.

• Evald Muraj - Senior Manager QC/Stability, Ironwood Pharmaceuticals

  
  Mr. Muraj has led stability programs in the bio-pharmaceutical sector for on-site manufacturing operations, virtual manufacturing models and global business networks that combine the two. His experience in global stability execution ranges from small molecule to biologics. His expertise focuses specifically on the use of statistical analysis and advanced degradative models to interpret shelf-life, and he has chaired multiple conferences on this subject for the past decade.

• Greg Norcross - QC Compliance Manager, Novartis Technical Operations

  
  Mr. Norcross has a background with over 30 years experience in management of pharmaceutical stability testing and analytical laboratory management including being the subject matter expert for numerous FDA audits and other internal and external audits.

• Peju Odunusi - Group Leader, Stability, Abbott Vascular

  
  Dr. Peju Odunusi is an analytical R&D professional with over 23 years of experience in the pharmaceutical and medical device industries. She has technical expertise in method development and validation, stability support for all phases of product development, method transfer, submissions, audits and has successfully established analytical and stability groups. She is also very passionate about mentoring.

• Junghae Scott - Director QC, Relypsa, Vifor Pharma Group Company

  
  Ms. Junghae Scott is a Director of Quality Control at Relypsa in Redwood City, California (a Vifor Pharma Group company). Ms. Scott has 30 years of industry experience in CMC, analytical development, and quality control covering Pharma, Biotech, Medical Device, and Combination Products from start-ups to Fortune 500 companies. She received her Master Degree in Chemistry at University of San Francisco.

• Emily S. D. Trubee, MS - Stability Manager, ADARE Pharmaceuticals

  
  Ms. Trubee is a pharmaceutical professional with 14 years of experience in Quality Control, and Stability Testing and Management, with a focus on regulations-compliant stability programs for sterile injectables, solid oral dosage forms, and biological products. In her current role as Stability Manager, Research and Development at Adare Pharmaceuticals, she is responsible for managing the stability lifecycle of all products from pre-clinical through commercialization. Emily earned her Bachelor of Science degree in Chemistry from Wilmington College in Wilmington, OH and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.

Sponsors

• SILVER

  

  
  

• ValGenesis

  

  Global Leader in Paperless Validation
  Website: http://www.valgenesis.com/

• VTI Life Sciences

  

  Inspiring Operational Excellence through Best-in-Class CQV Processes
  Website: http://validation.org/

• Wilco

  

  Leak Detection and Inspection Machines. Experience and innovation since 1971
  Website: http://www.wilco.com/

• Additional Sponsors

  

  
  

• Temple University School Of Pharmacy

  

  RAQA: Combined, Defined, and Online. The Leader in Education RA and QA Professionals for 50 Years
  Website: http://www.temple.edu/pharmacy_qara

Partners

• Pharmaceutical Outsourcing

  
  Addressing up-to-the-minute manufacturing challenges
  Website: http://www.pharmoutsourcing.com/

• American Pharmaceutical Review

  
  Coverage of the latest GXP developments
  Website: http://www.americanpharmaceuticalreview.com/

Venue

Pricing & Registration