Moderating this important, joint FDA-industry panel will be Jack Garvey, Founder and Chief Executive Officer of Compliance Architects®. Dina Maines, Managing Consultant, Compliance Architects® will participate on this panel as well.
The following outlines the forum and the participants.
FDA’s Quality Metrics Program — What are the Latest Developments and How They May Impact Risk-Based Inspections
The FDA will soon begin collecting quality data from drugmakers to develop scorecards for companies that ultimately will determine how often they will be inspected. CDER’s new Office of Pharmaceutical Quality considered recommendations from a range of stakeholders and has released a draft guidance (7.27.15) outlining the manufacturing and postmarket quality metrics drugmakers need to collect.
This panel of industry experts will explore the current state of the FDA’s quality metrics program, stakeholder efforts and other programs under development. They’ll profile what activities have been performed to date, examining both the potential benefits and possible risks.
The panel is comprised of the following individuals:
John C. (Jack) Garvey, Founder & Chief Executive Officer, Compliance Architects LLC
- Dina Maines, Managing Consultant, Compliance Architects LLC
- Karthik Iyer, Acting Branch Chief, Quality Intelligence Branch, OC, OPQ, CDER, FDA
- Nuala Calnan, PhD, Regulatory Science Research Fellow, Pharmaceutical Regulatory Science Team, School of Chemical & Pharmaceutical Sciences, Dublin Institute of Technology
- Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA; former Quality Assurance Specialist, Office of New Drug Quality Assessment, CDER, FDA
- Gil Roth, President, Pharma & Biopharma Outsourcing Association
- Louis W. Yu, Ph.D., Executive Vice President, Global Quality & Compliance, Perrigo Company plc
- Dan O’Leary, President, Ombu Enterprises