Agenda

Faculty

• Lokesh Bhattacharyya, Lab Chief, Division of Biological Standards and Quality Control, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, Food and Drug Administration

  
  Lokesh Bhattacharyya is a Lab Chief at the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to beginning his FDA work in 2006, he had over fourteen years of industry experience as an analytical chemist and biochemist. Dr. Bhattacharyya has thirty-nine papers, nine review articles, and nearly thirty conferences as speaker or session chair to his credit.

• Jay Chenier, Data Integrity Consultant, formerly, Process Owner, Global Computer Validation, GlaxoSmithKline

  
  Mr. Chenier is a leader in the Global Computer Validation organization currently on secondment with R&D automating data integrity controls for the next generation of analytical platforms. This includes developing a GxP lifecycle for use of Agile software development practices. He has 26 years of experience including leading the GSK implementation of Annex 11. More recently, he led adoption of the MHRA, FDA (draft) and WHO data integrity guidance documents into policy, procedures, communications and training.

• Anthony Chikere, Sr. Mgr. Process Validation/Cleaning and CPV, Bayer HealthCare, Berkeley

  
  Dr. Anthony Chikere is an experienced scientist with over 15 years of experience in different areas of Biopharmaceutical production including: process development, process monitoring and control, process validation and quality assurance. Since 2017, he is responsible for managing the Continuous Process Verification (CPV) program at Bayer HealthCare in Berkeley.

• Eric Collier, Discipline Lead Automation and IT, Commissioning Agents, Inc.

  
  Mr. Collier is an IT professional with more than 25 years of experience in CSV and the Software Development Lifecycle. His first introduction to computer system validation occurred in the early 1990’s as a software engineer working on Department of Defense (DOD) projects. These projects introduced him to the software engineering standards from which many of our current CSV best practices are derived.

• Eileen Cortes, Associate Director for QA and Validation, BioMarin

  
  Eileen Cortes is an Industrial Engineer and MBA professional with over fifteen years of experience in the biotech and pharmaceutical industry. Currently driving the computerized system global validation program as the QA CSV Associate Director at BioMarin.

• Norman Fraley, Executive Director, Frolich Institute

  
  Norman Fraley is the Executive Director of the Frölich Institute for Research in Sustainable Technology. After spending a year in Ethiopia, Norman became an advocate for the creation of robust and durable analytical tools that could be used in developing countries where resources and power were unreliable at best. This led to the formation of a non-profit Institute formed two years ago here in Winston-Salem. Mr. Fraley has spent the past thirty years in the field of Analytical Chemistry and serves as co-lead faculty for the Science of Sustainability at Wake Forest University’s Sustainability Graduate program focusing on Biomass and Bioenergy.

• John Hannon, Business Lead Automation And IT, Commissioning Agents, Inc.

  
  John Hannon is an Executive Consultant and Business Area Leader for Automation and IT at Commissioning Agents. With over 29 years in the pharmaceutical, IT, and process automation fields, he has been instrumental in starting up cutting-edge biotech facilities for companies such as Baxter, Monsanto, Amgen, Genentech, Pfizer, and Cook. He has managed multi-million dollar projects and project teams across the US and Europe, and is responsible for delivering hundreds of high-profile, mission-critical projects for biotech, pharmaceutical, and medical device customers. Currently he leads CAI's IT and Automation business area - responsible for the development of automation, MES, and other IT system projects within the international client base. With a demonstrated knowledge of quality assurance and regulatory compliance across the pharmaceutical industry, Mr. Hannon has led national and international seminars with ISPE, contributed to several publications such as Pharmaceutical Technology, and has led speaking venues related to risk-based approaches to smarter integrated system delivery compliant to the FDA, USDA, and EU regulatory agencies. He is an active and sought-after consultant for complex IT and automation problems in the pharmaceutical industry. Mr. Hannon holds a Bachelor of Science in Electrical Engineering from Georgia Tech, has completed studies at Harvard Business School, is a Certified Pharmaceutical Industry Professional and holds Professional Engineering certification in the state of North Carolina. Most recently he has worked with pharmacetical clients to resolve data integrity related regulatory citings.

• 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.

• Lou Killian, Director Customer Education, Kneat Software

  
  Lou Killian has extensive LifeScience leadership experience in Quality, Operations, Engineering Services, Regulatory, Business Systems with Abbott, Genentech, BioMarin. Lou’s passion is applying technology to meet business process needs. His current role is Director Customer Education & Success with Kneat Software.

• 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.

• Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality

  
  Dr. Byron Mattingly is currently the Chair of the Software Division of the American Society for Quality. He is a senior level systems and software quality engineering manager with over 17 years' experience in pharma, healthcare IT and medical devices. Dr. Mattingly graduated with a bachelor's from Princeton University, a PhD and Master's from Stony Brook, an MPhil from University of St Andrews (Scotland), and an MBA and a Master's in Public Health from the University of Massachusetts at Amherst.

• Carmen Medina, MPH, PhD(c), VP Technical Services, PAREXEL International, Former FDA Investigator

  
  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.

• 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.

• Horacio N. Pappa, CQE, Ph.D., Director – General Chapters Global Science and Standards Division, U.S. Pharmacopeia

  
  Dr. Pappa has been with USP since 2003. He hold the position of Principal Scientific Liaison at the Documentary Standard Division of the USP. He is the scientific liaison to the Expert Committees on Physical Analysis, Chemical Analysis and Statistics. Horacio earned his Ph.D. in Pharmaceutical Chemistry from the University of Buenos Aires. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to Chromatography and Validation. Prior to joining USP, he worked in the pharmaceutical industry in QA/QC. Horacio held the position of assistant professor of Quality Control in the Faculty of Pharmacy at Buenos Aires University, and Executive Secretary of the Argentine Pharmacopeia in the period 1997-2001. He is a Quality Engineer certified by the American Society for Quality.

• Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.

  
  Rashida Ray is the founder and president and of Array Validation Quality and Compliance (AVQC) Inc., which has been providing compliance and validation services to pharmaceutical, medical device and biotechnology industries since 2004. She is an experienced consultant with twenty years of experience working in in in all areas of validation and traveled the world on numerous validation/compliance engagements including 6 consent decree sites. For the past 17 years she has concentrated her expertise in the area of computer systems validation. She is also fluent in French and Portuguese languages.

• Tara Scherder, Partner, SynoloStats LLC

  
  Tara has over 25 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for the spectrum of product platforms. As partner at SynoloStats, she passionately shares the opportunity for patient and business benefit through the combination of statistics and process. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.

• 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.

• Steve Thompson, Senior Manager, Professional Services, ValGenesis, Inc. – South San Francisco, CA

  
  Steve has over 20 years of GxP experience in Life Sciences (including Medical Device), is a Parenteral Drug Association (PDA) certified Auditor, has held managerial positions at various levels within Information Technology (IT) and Quality Assurance (QA) for major organizations, is a published author, and has presented at several conferences and industry associations. Steve has a B.S. in Computer Information Systems from DeVry University, City of Industry, California.

• Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – Data Systems QA & Compliance, Shire

  
  Mr. Wherry has thirty-four (34) years of international pharmaceutical, biotechnology and medical device experience with expertise in Computerized System Validation, Data Integrity, Quality Systems, Process Validation, Aseptic Processing, Regulatory Operations and eCTD submissions. He has served as an industry consultant, performing data integrity audits around the globe at multiple companies. Bob currently is the Head of R&D Data Systems Quality Assurance and Compliance for Shire, in Lexington, Massachusetts.

Sponsors

• GOLD

  

  
  

• ValGenesis

  

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

• SILVER

  

  
  

• AVQC

  

  AVQC, Array Validation Quality & Compliance, Inc. is a Multinational Life Sciences Global Compliance Consulting Firm with 25 + years experience delivering Technical Writing and Validation Services in the Pharmaceutical, Medical Device, Biotechnology and Food Industries.
  Website: https://avqc.com/

• Bahnson

  

  Bahnson Environmental Specialties (BES) designs and manufactures a diverse product line of controlled environmental chambers that maintain precise conditions for clients' research, development, and manufacturing processes. BES has expanded from a respected regional company to a national leader in chamber design, on-site construction, and performance qualifications. Our 45 -year reputation is built on component quality, tolerance integrity, and an approach to engineering that exceeds even the most rigid requirements. Welcome to a Bahnson level of chamber precision.
  Website: http://www.eschambers.com

• Kneat

  

  Digitally Transforming GxP Validation Processes
  Website: http://kneat.com/

• Novatek

  

  Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries.
  Website: http://ntint.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/

• ACADEMIC

  

  
  

• 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

• American Pharmaceutical Review

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

• Pharmaceutical Manufacturing

  
  Keen insights into the major manufacturing issues facing the industry today.
  Website: http://www.pharmamanufacturing.com

• Pharmaceutical Outsourcing

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

Venue

Pricing & Registration