Martina LaGrange

Ms. Martina LaGrange began her career in Seattle, as an FDA Field Investigator. In 1996, she moved back home to Denver, where she worked for the FDA for a total of 14 years as a Medical Device Specialist. She has been consulting in FDA regulated industry since 2003.

Ms. LaGrange performed medical device, dietary supplements, pharmaceutical / drug, and clinical investigator inspections in the United States and internationally. She has inspected some of the largest manufacturers in the world, with 75% of these inspections resulting in the issuance of an FDA warning letter. On several recommendations for injunction, she was the lead investigator.

Ms. LaGrange was a member of the FDA's Quality System Inspection Technique (QSIT) Reengineering Team. She assisted in creating a QSIT training CD-ROM and a QSIT CD exam. She also helped develop QSIT training for FDA managers and FDA compliance officers and was a presenter on the 7/00 LIVE video downlink that trained managers and compliance officers worldwide.

For her accomplishments in the medical device arena, Ms. LaGrange received Vice President Al Gore's Government Hammer Award.  She was also part of the Medical Device EIR (Establishment Inspection Report) workgroup, created to harmonize FDA inspection reports in accordance with the Mutual Recognition Agreement (MRA). Ms. LaGrange provided classroom training to FDA employees, European Union (EU) authorities, Colorado Department of Health and Environment workers, trade groups, and professional societies.

Since 2003, Ms. LaGrange has been an FDA consultant in the medical device, dietary supplements, pharmaceutical / drug, and clinical investigator areas. She continues to assist FDA-regulated companies in obtaining and maintaining compliance with FDA regulations.

Ms. LaGrange's expertise includes:

• gap analysis
• quality control reviews
• mock FDA audits
• 483 and Warning Letter responses
• SOP development (Standard Operating Procedures)
• MDR (Medical Device Reporting)
• S/AER (Serious / Adverse Event Reporting)
• training on FDA requirements (laws and regulations)
• FDA readiness training (preparing for an FDA inspection)
• compliance strategy planning