Holmdel, NJ (PRWEB) June 20, 2011
WHAT: Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it will join representatives from leading life sciences organizations and regulators in an interactive session at the 2011 Association of Food and Drug Officials Conference, June 18-22, in Plano, Texas. The session, titled “Writing CAPA Procedures & Documents to Reflect Compliance Initiatives,” will bring together representatives from Ortho Clinical Diagnostics (a Johnson and Johnson company), Kinetic Concepts, Inc., and the Food and Drug Administration (FDA), for a moderated discussion on best practices in initiating corrective and preventive actions (CAPAs) in their manufacturing and regulatory compliance efforts.
Organizations in highly regulated industries face stringent regulations for tracking and reporting on incidents that occur in the manufacturing process, and are required to institute actions to both correct issues and take the steps necessary to ensure that the incidents to not arise again. “Writing CAPA Procedures & Documents to Reflect Compliance Initiatives” will arm attendees with the tools they need to determine the threshold of when to initiate a CAPA procedure, and provide instruction on how to accurately classify specific actions as corrective and preventive. Ultimately, those who attend the presentation will walk away with a new understanding of when, how and why to issue CAPAs in their own organizations, to ensure compliance with both current and future regulatory guidelines.
- Tim Mohn, Industry Principal, Sparta Systems
- Paul A. Arrendell, Vice President, Global Quality, Kinetic Concepts, Inc.
- Virginia Connelly, Director of Investigations, FDA/Cincinnati District
- Judy Strzepek, Director Quality, Ortho Clinical Diagnostics, a Johnson and Johnson Company
WHEN: “Interactive Session: Writing CAPA Procedures & Documents to Reflect Compliance Initiatives”
Tuesday, June 21, 2011, 3:20 p.m.-4:20 p.m.
WHERE: Marriott Dallas/Plano at Legacy Town Center
7120 Dallas Parkway
Plano, Texas 75024
CONTACT: For information on TrackWise products or services, visit http://www.spartasystems.com.
About Sparta Systems: Sparta Systems, Inc. is an industry leader for global quality and compliance management systems. Its TrackWise® product is a Web-based software application used by quality, manufacturing and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 15 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. Read more about Sparta Systems and TrackWise software on the corporate website and blog http://www.spartasystems.com/blog.spartasystems.com.