2018 ISPE Pharmaceutical Manufacturing Conference

Managing the Global Pharmaceutical Supply Chain:  How Pharmaceutical Quality System (PQS) Ensures Sustainable Compliance

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

  1. Learn how to avoid the regulatory challenges by assuring accurate, reliable, complete information in drug product application submissions
  2. Gain an understanding how to apply key ICH Q10 Principals
  3. 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

Vivianne J. Arencibia
Vivianne J. Arencibia
VP and Global Head
External Engagement for Novartis Group QA
Novartis
Joseph C. Famulare
Joseph C. Famulare
Vice President
Global Quality Compliance and External Relations
Genentech
Uday Chandrashekhar Shetty, Ph.D
Uday Chandrashekhar Shetty, Ph.D
Co-Founder
Contract Research Organization
Frances M. Zipp
Frances M. Zipp
President & CEO
Lachman Consultant Services
Richard L. Friedman
Richard L. Friedman
Deputy Director, Science and Regulatory Policy
FDA/CDER/OC/OMQ
Carmelo Rosa, PsyD
Carmelo Rosa, PsyD
Director, Division of International Drug Quality
FDA/CDER, OC/OMQ