Avoiding a Warning Letter in the FDA's New Enforcement Environment
Washington, DC (Vocus) October 5, 2010
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 present at the upcoming educational event, “Avoiding a Warning Letter in the FDA's New Enforcement Environment” on Wednesday, Oct. 6, 2010 from 12:45 – 1:45 pm. https://www.advamedmtli.org/go.cfm?do=Register.ShowForm1&wid=118
The session will focus on best practices for businesses to write corrective and preventive action (CAPA) records that reflect the organization’s compliance initiatives.
Ensuring both regulatory and medical device professionals have the tools to avoid warning letters and to demonstrate commitment to compliance initiatives will become increasingly important as the FDA increases its oversight of the medical device industry. The FDA’s new focus on the effectiveness of its enforcement system and emphasis on protecting public health has resulted in hundreds of additional observations and new warning letters this year. Using the versatile TrackWise platform, companies can automate CAPA records and track and manage the process of compiling CAPA records - demonstrating an effective quality system.
WHO: Tim Mohn, Industry Principal for Sparta Systems and former Manager, Worldwide Quality
Systems for Johnson and Johnson Ortho-Clinical Diagnostics
WHEN: Wednesday, Oct. 6, 2010, 12:45 – 1:45 pm.
WHERE: Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
920 Massachusetts Avenue, NW, Suite 900
Washington, DC 20001
CONTACT: For information on TrackWise products or services, visit
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.