Presentation: Panel Discussion on Topics such as Sustainability, MES Integration, CPV

Industry

• Pharmaceuticals & Life Sciences

Company

Speaker

Michael Purcell is the Industry Principal for Life Sciences from OSIsoft. Michael has worked for and with Life Sciences companies since 1995.

Company

Speaker

Dennis Brandl is the founder and chief consultant for BR&L Consulting, specializing in Manufacturing IT applications, including Business-to-Manufacturing Integration, MES solutions, General and Site Recipe implementations, and automation system security. He has been involved in automation system design and implementation in a wide range of applications over the past 25 years. They have included biotech, pharmaceutical, chemical plants and oil refineries, food manufacturing, consumer packaged goods, and aerospace systems. Dennis Brandl has been an active member of the ISA 95 Enterprise/Control System Integration committee for the past ten years and is editor of the set of standards. He is a USA expert on batch control to IEC, is the former chairman of the ISA 88 Batch System control committee, and is the chairman of the IEC and ISO Joint Working Group on Enterprise/Control Integration. Mr. Brandl has written numerous papers and articles on business to manufacturing integration and flexible manufacturing solutions, has a regular column in Control Engineering, and has authored the book “Design Patterns for Flexible Manufacturing”, available through ISA. Brandl has a BS in Physics and an MS in Measurement and Control from Carnegie-Mellon University, and a MS in Computer Science from California State University.

Company

Speaker

Martin Browning is the President and Co-Founder of EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of regulatory experience at the FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work in the field offices as an investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters. He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs. He also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, Martin served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR). At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering, and compliance auditing, including the assessment of vendors and outsourced operations. His specific experience also includes quality systems design, system design assurance and verification, and the validation of biopharmaceutical and device systems, processes and software. Martin is the chairman and developer of many of EduQuest’s popular training courses, including the three-day FDA Auditing of Computerized Systems and Part 11 course. This class is based on the program EduQuest originally developed at FDA’s request to train agency field investigators, analysts and compliance staff on Part 11 rules and the inspection of computerized systems. He has been the featured keynote speaker for industry conferences held throughout the U.S. and overseas, and he has published many articles in the trade press. In addition, Martin has written EduQuest Advisory papers on “The Hot Potato of Responsibility: How to Manage Outsourcing and Not Get Burned” and “Medical Device Concessions: Free Pass or Red Flag for Your Quality System?”. He was named Speaker of the Year in 2004 by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other industry organizations.

Company

Speaker

Mr. Kenyon is the Director of Systems for the Pharmaceutical Development and Manufacturing Sciences group at Janssen Research and Development, a pahrmaceutical company of Johnson and Johnson.

Company

Speaker

Jon Peterson is OSIsoft's Chief Market Strategist. Jon has been with OSIsoft since 1992. He was most recently VP of Engineering, and before that led the PI Server group, demonstrating strong leadership in both the PI System flagship technology and product rollouts. Jon had nine years of experience working in Process Engineering before coming to OSIsoft. Jon earned a Bachelor of Science in Chemical Engineering from Northwestern University.