Connecting Pharmaceutical Knowledge
2018 ISPE Pharmaceutical Manufacturing Conference
Managing the Global Pharmaceutical Supply Chain: How Pharmaceutical Quality System (PQS) Ensures Sustainable Compliance
Please Note: Conference registration for this meeting is full. At this time, we are only accepting waitlist requests. Please contact Uday Shetty to be placed on the waitlist.
Sponsorships and Exhibit space are STILL available! Please contact Uday Shetty for more information.
Over three full days hear from FDA, MHRA, and pharmaceutical industry experts as they set the framework for discussion on basic quality systems as well as the influence of ICH Q10 on the industry as a whole. As companies continue to address issues such as data integrity, the quality systems platform of ICH Q10 becomes increasingly important to understand and embrace. The 2018 ISPE Pharmaceutical Manufacturing Conference will examine common issues and address how companies can reach a quality maturity level and use knowledge and process understanding throughout the lifecycle of the product.
Pharmaceutical industry experts will share examples of broken, unreliable and reactive quality systems, and the transformation needed to move to a sustainable, predictable quality environment and concepts of Quality Risk Management through risk-based regulatory approaches.
Learning Objectives
- Learn how to avoid the regulatory challenges by assuring accurate, reliable, complete information in drug product application submissions
- Gain an understanding how to apply key ICH Q10 Principals
- Learn the do’s and don’ts in every stage of process verification (process design, process qualification, and continued verification
Who Should Attend?
The 2018 ISPE Pharmaceutical Manufacturing Conference is designed for a focused audience of pharmaceutical professionals from pharma, bio, and generic companies and regulatory agencies, including those at the executive and management levels, pharmaceutical scientists and engineers, manufacturing supervisors, development and production functions, audit functions, and suppliers.
Program Committee
Conference Supporters
Featured Speakers
As Director of CDER’s Office of Compliance, Donald D. Ashley, J.D., leads efforts to shield the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards
Richard L. Friedman is the Deputy Director, Science and Regulatory Policy, Office of Manufacturing and Product Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). In this position, he is responsibl
Carmelo Rosa has a B.S., M.S., Psy.D. His background is in biology and chemistry, and holds a doctoral degree as a Clinical Psychologist. He has been with FDA for over 27 years. In May 1990, he started as an Investigator for the Los Angeles district,
Joseph Famulare is Vice President - Global Quality Compliance and External Collaboration at Genentech/Roche, Pharma Technical Operations. He is active in aligning industry and international regulatory authorities around policy and harmonization, and
Frances (Fran) M. Zipp is President & CEO of Lachman Consultant Services, Inc. Lachman Consultants provides compliance, regulatory and technical consulting services to the global pharmaceutical and related industries and Ms. Zipp delivers the strateg
Dr Ranjana Pathak is President, Global Quality, Medical Affairs and Pharmacovigilance, at Cipla Limited. At Cipla, Ranjana is part of the six-member Management Council, the apex executive leadership team of Cipla responsible for its overall vision an
Georges has an experience of over 25 years in the Pharmaceutical Industry. He started his career in a hospital as an Intern Biologist. Before joining Novartis in March 2012, Georges was VP of Global Quality Strategy & Affiliates Quality with Pfizer.
Thomas Schreiner is a Pharmacist with 23 years experience in the Pharmaceutical Industry, focusing on sterile manufacturing. He is currently the Head of Quality Management Dvision Pharmaceutical with Fresenius Kabi. Mr. Schreiner holds a PhD in Pharm
Nuala Calnan, PhD has over 20 years’ experience in the pharmaceutical industry and is currently an adjunct Research Fellow with the Pharmaceutical Regulatory Science Team at DIT, Ireland, where she leads a number of patient focused regulatory science
Maurice Parlane is Principal of New Wayz Consulting Ltd in New Zealand and a Director of CBE Pty Ltd in Australia. He is a professional engineer with 30 years’ experience within the biopharmaceutical industry, including 20 years as an industry consul
Tony (Antonio) Crincoli, PE is Vice President of Global Engineering at Glenmark Pharmaceuticals, with oversight over all major capital projects, strategic project planning, project governance, execution, asset management and Technical Services. He ha
David Churchward Expert GMDP Inspector Medicines and Healthcare products Regulatory Agency (MHRA) David Churchward has been a GMP inspector with the UK Medicines and Healthcare Products Regulatory Agency since 2004. In his current role, David is resp
Prashant Sharma manages Manufacturing & Operations for Formulations across Zydus Cadila's entire mfg footprint. He is a part of Zydus Senior Leadership Team and has held leadership positions in Global Supply Chain, IT, Human Resources & Manufacturing