Welcome!

News Feed Item

3rd Annual ISPE-FDA CGMP Conference to Address Latest Compliance Trends and Clarify Regulatory Expectations

TAMPA, Fla., March 28, 2014 /PRNewswire-USNewswire/ -- Top officials from the US FDA will meet with ISPE Members and other pharmaceutical industry leaders to discuss compliance trends and identify practical solutions for modern quality systems, technology transfer, metrics implementation and other relevant topics during the third annual ISPE-FDA CGMP Conference, taking place 2 – 4 June in Baltimore, Md. USA. The conference will explore industry hot topics in an ongoing conversation between ISPE Members and FDA to advance contemporary methods of ensuring a reliable supply of medicines. During the event, ISPE will also report on its Drug Shortages initiative.

ISPE logo.

"This annual ISPE-FDA event is well positioned to address recent comments by FDA Commissioner Margaret Hamburg around the criticality of maintaining a reliable drug supply and harmonization of global regulatory perspectives which are priorities for regulators and industry alike," said Nancy Berg, ISPE President and CEO. "The ISPE-FDA CGMP Conference is the ideal setting for addressing critical issues related to product quality and manufacturing readiness, with an agenda developed jointly by FDA and ISPE that emphasizes focused, productive and solution-driven dialogue designed to move the industry forward."

Dr. Janet Woodcock, Director, CDER, FDA, will be one of the plenary speakers for the event. Dr. Woodcock's remarks at the inaugural CGMP Conference in 2012 set the tone for much of the regulatory-industry collaboration that has occurred since the inception of this signature event. It is expected that her statements at this year's event will include an update on the FDA's Office of Pharmaceutical Quality and implementing and measuring a culture of quality. Pfizer VP, Global Quality Operations Mary Oates, PhD and AstraZeneca Executive Vice President David Smith will also present at the plenary session.

Conference content has been developed by a program committee comprised of senior leaders from both FDA and ISPE, including:

  • Mike Arnold, Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies, USA
  • Paul D'Eramo, Vice President, Pharmaceutical Regulatory Compliance, Johnson & Johnson, USA
  • David Doleski, Director, Division of DGMPA, FDA
  • Joe Famulare, Vice President, Global Compliance, Genentech Inc., USA
  • Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA
  • Brian Hasselbalch, Consumer Safety Officer, CDER, FDA
  • Charles Hoiberg, Executive Director, Pfizer Inc., USA
  • Tim Howard, Vice President, Global Operations, Commissioning Agents, Inc., USA
  • Steve Lynn, Director, Office of Manufacturing and Product Quality, FDA
  • George Millili, Senior Principal Technical Advisor, Genentech Inc., USA
  • Mike Smedley, Deputy Director, Office of Compliance, FDA

Sessions, case studies and workshops will focus on new and emerging trends in compliance; development, pre-approval and technology transfer; end-to-end process control; metrics implementation; combination products; breakthrough therapies; and practical solutions to drug shortages.

Complete details of the event, including program and registration information, are available at www.ISPE.org/2014-CGMP-Conference. To obtain media credentials to cover the event, please contact ISPE Manager, Marketing Communications Danielle Hould at [email protected].

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit www.ISPE.org for more information.

For more information contact:
Danielle Hould
Manager, Marketing Communications, ISPE
Tel: +1-813-960-2105, ext. 277
Email: [email protected] 
www.ISPE.org

Photo - http://photos.prnewswire.com/prnh/20120912/DC73253LOGO

SOURCE ISPE

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
CIOs and those charged with running IT Operations are challenged to deliver secure, audited, and reliable compute environments for the applications and data for the business. Behind the scenes these tasks are often accomplished by following onerous time-consuming processes and often the management of these environments and processes will be outsourced to multiple IT service providers. In addition, the division of work is often siloed into traditional "towers" that are not well integrated for cro...