Big Event – 2016

Quality System Survival: Success Strategies for P&PC/CAPA

Date and Time: April 15, 2016 from 8 a.m. to 5 p.m.

Location: Courtyard Dallas DFW Airport North/Grapevine, 2200 Bass Pro Court, Grapevine, TX 76051 USA. Go to this link to use the special group rate for the night before the event (offer expires after 3/24/16). Update: The special group rate offer has been extended through 4/12/2016.

Agenda: The agenda for the workshop can be downloaded as a PDF here.

Final Presentation: The final presentation that the speakers will be presenting can be downloaded as a PDF via this link. A Powerpoint (PPT) file of Robert Freeman’s presentation can be downloaded here.

Contact: Staci G. McAllister, Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, email:

Registration: Industry $250, government with ID $150, student $50 available until March 11, 2016. Registration after March 11, 2016 increases to industry $300, government with ID $200, with student registration staying the same at $50. On-line registration begins February 1, 2016. To register online, please visit As an alternative, send registration information including the registrant’s name, title, organization, address, telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to FMDIC, Inc., to FMDIC Registrar, 4447 North Central Expressway, Suite 110, PMB 197 Dallas, TX 75205.

If you need special accommodations due to a disability, please contact Staci McAllister (see Contact) at least 7 days in advance.

The workshop is being held in response to the interest in the topics discussed from small medical device manufacturers in the Dallas District area. This workshop helps achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), as an outreach activity by Government agencies to small businesses.

The goal of the public workshop is to present information that will enable manufacturers and regulated industry to better comply with FDA’s medical device requirements.