Kick-off the Product Show with our keynote & awards session complete with coffee and breakfast! This year, our keynote session features two presenters with extensive insights into the challenges of assuring pharmaceutical drug quality across a global and complex supply chain: Katherine Eban, investigative journalist and New York Times Best-Selling Author of Bottle of Lies and Dangerous Doses, and Peter Baker, Vice President of Green Mountain Quality Assurance. Read on for information about this session and our speakers.
Managing Quality from Afar
We all know that Quality is every employees responsibility in the life science industry; from designing new drug modalities, devising meaningful clinical studies under strict time pressures, rationalizing and simplifying manufacturing processes to assure both quality, availability and affordability, monitoring distribution effectiveness, to confidently demonstrate sound scientific based data to health agencies. Having confidence in today’s global economy, for the affordable availability of safe and effective pharmaceuticals, is a challenge for a highly distributed supply chain. Katherine and Peter will discuss with our host, Heather Longden, some of their thoughts on how to promote and monitor a high confidence in quality from afar, and what that means for US based companies that leverage overseas sites.
About Our Speakers
Katherine Eban, an investigative journalist, is a Vanity Fair contributing editor and Andrew Carnegie fellow. Her articles on pharmaceutical counterfeiting, gun trafficking, and coercive interrogations by the CIA have won international attention and numerous awards. She has also written for Fortune Magazine, the New York Times and other publications. Her work has been featured on 60 Minutes, Nightline, NPR, and other national news programs. She lectures frequently on the topic of pharmaceutical integrity.
Her second book, Bottle of Lies: the Inside Story of the Generic Drug Boom (May 2019) was a New York Times bestseller. Based on a decade of reporting, the book takes readers deep into the overseas manufacturing plants where the majority of our low-cost generic medicine is made. It reveals endemic fraud and dire conditions in an industry where companies routinely falsify data and circumvent safe manufacturing practices to minimize cost and maximize profit.
Her first book, Dangerous Doses: a True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply, was named one of the Best Books of 2005 by Kirkus Reviews and was a Barnes & Noble Discover Great New Writers pick. Her work has also been awarded grants from the Alfred P. Sloan Foundation, the Fund for Investigative Journalism, the Alicia Patterson Foundation and the McGraw Center for Business Journalism at CUNY’s Craig Newmark Graduate School of Journalism.
Educated at Brown University and Oxford University, where she was a Rhodes Scholar, she lives in Brooklyn with her husband, two daughters and Newfoundland dog Romeo.
Peter E. Baker spent 11 years as an FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity, and has special interest in big data management and compliance with 21 CFR Part 11. He speaks Chinese (Mandarin) and Spanish, and has performed more than 100 foreign drug inspections around the world on behalf of the FDA. His inspection experience includes performing six systems manufacturing inspections of API’s, intermediates, and finished dosage, including complex small and large molecules.
Peter specializes in training specifically on Good Manufacturing Practices and Quality Culture; he believes that one cannot exist without the other. He has organized and executed training programs around the world, tailored for both Industry and National Health Authorities. Past topics have included basic to advanced GMP, biotherapeutics and advanced cell therapies, investigations and CAPA, inspection techniques, data integrity, and quality culture, among others.
Peter holds a Bachelor of Science (B.S) degree in Biology-Chemistry from Point Loma Nazarene University, a Masters of Science (M.S.) in Chemistry from San Francisco State University, and is an active member of PDA, DIA, and ISPE.
About Our Moderator Heather Longden, Pharmaceutical Regulatory Intelligence, Waters Corporation
After a number of years in training, supporting and selling Waters Software, Heather’s current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products.
This involves helping design the compliance into our informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations.
As well as for internal education, Heather is also often called on to present on the latest Data Integrity observations to users of UNIFI, NuGenesis and Empower. Along with Waters Professional Services experts, Heather offers advice to users how to design Standard Operating Procedures and configure the applications to take advantage of the technical controls built into the applications.
Heather is also active in the ISPE GAMP Community of Practice and the ISPE Boston Chapter (Education Program Committee) where she is called on as an expert in Data Integrity, specifically around the chromatographic analysis process, and all things regulatory in that area.