ASQ BioMedical Division and FDA Medical Device Industry Coalition – Big Event – April 15, Dallas, TX

Big Event 2016 – Final Meeting Agenda Posting

Quality System Survival: Success Strategies for Production & Process Control,   and 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.  Telephone (817) 251-9095

Every two years FMDIC, with the participation of ASQ Biomedical Division, hosts the “Big Event”, an educational forum for members of the medical device industry to gain more knowledge on how to best implement quality system practices in their organization to ensure product quality and safety, while meeting the requirements of the FDA regulations.  This year’s event focuses on Production and Process Control combined with CAPA, which remain key warning letter citations for many firms.  This event is an all-day seminar which will feature speakers from FDA, academia and industry giving their thoughts on how to best manage these processes in a manufacturing organization.

Because there is a limited capacity for this event, we recommend advanced registration. Click on the link below to register online and reserve your seat.  Be sure to contact the Marriott Courtyard Dallas – DFW Airport North Hotel to reserve your guest room, if needed, under the FMDIC, Inc. room block to receive a reduced rate as well. 

Registration Fee: Industry $300, Government with ID $200, and Student registration with ID $50. To register online, please visit https://www.123signup.com/register?id=pnrxz. 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 at least 7 days in advance at Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5259, FAX: 214-253-5314, email: Staci.McAllister@fda.hhs.gov.

FMDIC is a non-profit coalition, composed of key employees of the FDA offices in Dallas, officials from the Texas Department of Health, academic members as well as individuals from professional and trade associations representing the medical device industry, including ASQ and the ASQ Biomedical Division.  FMDIC was formed to promote communication, education and cooperation between the regulators and the regulated industry.