On October 23, 2014, the annual FDAnews Inspections Summit will be the forum for an exciting, informative panel focused on the FDA’s upcoming Quality Metrics program. Moderating this important, joint FDA-industry panel will be Jack Garvey, Founder and Chief Executive Officer of Compliance Architects^®. 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

In 2015, the FDA expects to start collecting quality data it will use to determine inspectional frequency and rigor of drug and biologics makers. The data being considered could include number of lot release tests, out-of-specification results, and lots attempted, rejected, reworked, and reprocessed along with potentially other metrics as yet undetermined. In addition, by the end of this year, the International Society for Pharmaceutical Engineering (ISPE) intends to have initial results of their own quality metrics reporting pilot program. They will be sharing their findings with FDA on how manufacturers are coping with the collection and reporting process.

This panel of industry experts will explore the current state of the FDA’s quality metrics program, ISPE efforts and other programs under development within the industry. They will profile what activities have been performed to date, examining both the potential benefits and possible risks.

The panel is comprised of the following individuals:

Moderator:

John C. (Jack) Garvey, Founder & Chief Executive Officer, Compliance Architects LLC

Panelists:

• Dr. Neil Stiber, Operations Research Analyst, Office of Strategic Programs, CDER, FDA
• Dr. Patrick Brady, Deputy Vice President of Scientific and Regulatory Affairs, PhRMA
• Kevin Roberson, Director, CGMP Quality Assurance, ABC Laboratories
• Máiréad Goetz, Head of Compliance, Group Compliance and Audit, Group Quality Assurance, Novartis Pharmaceuticals
• Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA; former Quality Assurance Specialist, Office of New Drug Quality Assessment, CDER, FDA
• Reem Malki, Vice President, Global Quality Operations, Mylan

Take the Pharmaceutical Metrics Survey!

In an effort to identify current industry readiness for and existing concerns about the FDA Quality Metrics Program, FDAnews, in cooperation with Compliance Architects^®, is seeking pharmaceutical industry input in advance of the 2014 Inspections Summit. Specifically, FDAnews and Compliance Architects^® have developed a broad-based survey to obtain data on industry’s state of readiness. We are NOW SEEKING YOUR HELP. Please follow the link below to access and respond to this important survey. Survey results will be shared with Inspections Summit attendees and published in subsequent FDAnews information offerings for broader industry awareness. To participate, click here to access and complete the survey: FDAnews Inspections Summit Metrics Survey

For further information on getting ready for FDA’s pharmaceutical quality metrics program, contact Jack Garvey, Compliance Architects^® at  john.garvey@compliancearchitects.com or at 888-REG-XPRT.