Principal, FDA Compliance Group LLC
Ms. Martina LaGrange began her career in Seattle, WA as an FDA Field Investigator. She moved back home to Denver, CO in 1996 where she completed her 14 year career with the FDA as a Medical Device Specialist.
Ms. LaGrange performed medical device, dietary supplement, pharmaceutical and clinical investigator inspections both domestically and internationally. She inspected some of the world’s largest manufacturers, with 75% of inspections resulting in the issuance of a Warning Letter. She was the lead investigator on several injunction recommendations.
Ms. LaGrange was a member of the Quality System Inspection Technique (QSIT) Reengineering Team. She assisted in creating QSIT Training CD-ROM and QSIT CD Exam. She assisted in developing QSIT Training for FDA managers and compliance officers, and was a presenter on the 7/00 LIVE video downlink that trained FDA managers and compliance officers nationwide. She received Vice President Gore’s Government Hammer Award for her accomplishments in the device arena. She was also part of the Medical Device EIR (Establishment Inspection Report) Workgroup, created to harmonize FDA’s inspectional reports in accordance with the Mutual Recognition Agreement (MRA). She provided classroom training to FDA employees European Union authorities, Colorado Department of Health and Environment, trade groups, and professional societies.
Ms. LaGrange has been consulting in the medical device, dietary supplement, pharmaceutical and clinical investigator areas since 2003. She continues to assist FDA regulated companies in gaining compliance with the FDA regulations. Her focus includes gap analysis, quality control reviews, mock FDA audits, training, SOP development, MDR and Adverse Event Reporting.
- San Diego, CA | Thursday, February 4, 2016 | Friday, February 5, 2016
- Chicago, IL | Thursday, April 21, 2016 | Friday, April 22, 2016
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