PD2M Advanced Process Control Workshop

Moving APC Forward in the Pharmaceutical Industry
September 30 - October 1, 2019
Add to Calendar

The intent of this workshop is to bring the community together to have a focused dialogue on challenges with implementing advanced process control, to share best practices and current successes, and to better understand how we can move the field forward together.

Register Today

Technical Program

PD2M Advanced Process Control (APC) Workshop

Moving APC Forward in the Pharmaceutical Industry

The current state of process control in the pharmaceutical industry is predominantly based on approaches where input process parameters are validated and controlled at fixed set points or tight ranges. While often resulting in acceptable product quality, these control techniques using recipe and PID-based control are unable to adequately adjust the parameters to account for variations from raw materials, process disturbance and environmental conditions, and thus result in variability in quality and productivity. Contrary to traditional process control, the main objective of Advanced Process Control (APC) is to maintain process outputs at predefined set points, by manipulating process inputs within flexible ranges. APC is gaining an increased use in the industry to drive more consistent product quality and maximal economic output such as yield, throughput and reduced cycle time. 

APC is a mature field widely used by many manufacturing industries, such as Oil & Gas and Chemicals., however the implementation of APC within the pharmaceutical industry is lagging. There are practical considerations when implementing APC in the pharmaceutical industry due to technical complexity of the products, the need to validate and maintain APC application within a GMP environment, and existing practices and culture. The intent of this workshop is to bring the community together to have a focused dialogue to better understand the current opportunities, challenges, and best practices for overcoming these barriers. This workshop is designed to promote interaction and dialogue; provide attendees with the opportunity to learn and to impact the discourse on how stakeholders (industry, academia, regulators) can work together to move the implementation of APC forward in the pharmaceutical industry for the benefits of patients.

Keynote Speakers:

Invited Speakers:

  • David Lauri Pla, Pfizer
  • Eoin McManus, APC Ltd
  • Kashif Ahmed, Biogen
  • John Mack, Perceptive
  • Malcom Jeffers, IAAE
  • Martin Warman, ASTM
  • Sharmista Chatterjee, FDA
  • Krishnakali Ghosh, FDA
  • Chris Garvin, Amgen

Conference Chairs:

  • Jun Huang, Pfizer
  • Thomas O'Connor, FDA

Organizing Committee: 

Featured Speakers

Sau (Larry) Lee

Sau (Larry) Lee joined FDA in 2005 and has served as regulatory scientist, CMC team leaders, Associate Director for Science, and Deputy Office Director. Larry is currently the Director for Office of Testing and Research within OPQ, and he is also the chair for OPQ led Emerging Technology Program and led a multi-disciplinary team with representation from OPQ, OC and ORA to support the development, implementation and regulatory evaluation of novel technologies for pharmaceutical applications. He provides leadership in developing and implementing OPQ science and research programs to advance...Read more

Cenk Undey

Dr. Undey joined Amgen in 2003 and has held positions of increasing responsibility in Process Development which included providing manufacturing support, continuous process improvement of commercial products, and technology transfers. He has formed the Digital Integration and Predictive Technologies in 2013, a corporate group with a mission to transform Amgen business from data rich to decision smart. His group’s aim is to improve process and product understanding, process optimization, reduce process development cycle time hence increasing speed to market with reduced development costs...Read more

Venkat Venkatasubramanian

Professor Venkat Venkatasubramanian is Samuel Ruben-Peter G. Viele Professor of Engineering in the Department of Chemical Engineering, Professor of Computer Science (Affiliate), and Professor of Industrial Engineering and Operations Research (Affiliate) at Columbia University in the City of New York. He earned his Ph. D. in Chemical Engineering at Cornell, M.S. in Physics at Vanderbilt, and B. Tech. in Chemical Engineering at the University of Madras, India. Venkat worked as a Research Associate in Artificial Intelligence in the School of Computer Science at Carnegie-Mellon University. He...Read more