MD&M West 2012 Conference to Feature FDA Speakers

Eager to avoid regulatory mistakes? Attendees at the upcoming MD&M West 2012 conference will get the chance to hear from FDA on warning letters, inspections, submissions, and more. The just-announced line-up offers several FDA representatives along with experienced consultants.

Highlights of the event include the following presentations:

February 14:

Morning: CDRH Top Headquarter Officials Discuss Product Clearances and Quality System Compliance for 2012
Moderator: Nancy Singer, President, Compliance-Alliance, LLC

Interacting with FDA: William Sutton, Deputy Director, DSMICA, FDA

  • CDRH’s regulatory structure
  • Available resources
  • Do’s and don’ts for interacting with FDA officials

Products Clearances: Christy Foreman, Director, ODE, FDA

  • 2011 review times for 501(k)s, IDEs and PMAs
  • How to avoid mistakes that will slow the submission process
  • How FDA is interpreting the “least burdensome” approach in the submission process

Complying with the Quality System Regulation: Melissa Torres, Biomedical Engineer, OC,
CDRH, FDA

  • 2011 review times for 510(k), IDEs and MPAs
  • How to avoid mistakes that will slow the submission process
  • How FDA is interpreting the "least burdensome" approach in the submission process

Afternoon: Activities in the FDA's LA District
Moderator: Helene Spencer, ClinReg Consulting Services, Inc.

FDA, Los Angeles District - An Update: Alonza Cruse, Los Angeles District Director, FDA

  • Inspections activities in 2011
  • Most common 483 and warning letter citations
  • Inspection priorities in 2012
  • Barriers to Medical Device Quality

How the LA District is implementing FDA's New Import Program: Dan Solis, Director of Import Operations, FDA Los Angeles District

  • Import statistics for 2011
  • How the new import program PREDICT will affect imports
  • What to do if your device is stopped at the border

Avoiding Serious Mistakes in Your Quality and Regulatory Records: Nancy Singer

  • How statements in company records and premarket submissions can be misinterpreted by FDA investigators and reviewers
  • The risks of writing too much or too little in your documents
  • Who should and who should not write opinions on FDA regulatory matters
  • How to write CAPA reports that will answer FDA questions before they ask them

February 15:

Revelations of Former FDA and Department of Justice Officials
Moderator: Nancy Singer, President, Compliance-Alliance, LLC

Faculty: Ron Johnson, former Regional Director, FDA's Pacific Region, Elaine Messa, former District Director, FDA’s LA District, Nancy Singer, former DOJ prosecutor specializing in FDA matters

  • How FDA Prepares and Plans for Inspections
  • Investigative Principles and Techniques
  • 483s. Warning Letters, and EIRs

Afternoon: Gearing Up For Complying with FDA Requirements

Moderator: Nancy Singer

To view the complete program, please visit the MD&M West conference agenda page.

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