louis kaufman
president
About
Over 33 years of FDA experience in planning, developing, and administrating compliance policies and enforcement activities, in CDRH (22 years) and in conduting inpections and handling recall and emergiencies in New York District Office (11 1/2 years).
united states
charleston
medical devices
gmp, design of experiments, risk management, quality auditing, cross functional team leadership, policy, fda, iso, iso 13485, team building, regulatory affairs, quality system, 21 cfr part 11, clinical trials, regulatory requirements, pharmaceutical industry, regulatory submissions, manufacturing, r&d, glp, v&v, product development, quality management, quality assurance, medical devices, capa, validation, auditing, technology transfer, lifesciences, biotechnology, clinical research, change control, design control, sop, quality system regulation for medical devices, review and evaulate mdr's, mdr, project planning, iso 14971, internal audit, clinical development, gcp, life sciences
Experience
special assistant for enforcement, doe i
fda's center for devices & radiological health
special assistant for enforcement, doe i, oc
fda cdrh
acting chief, general hospital branch
fda's center for devices & radiological health
special assistant for enforcement and doe i
fda/center for devices and rad health
president
to the point consulting
With over 33 years of FDA experience, both as an investigator in the New York District Office and as the Special Asst. for Enforcement, DOE A in the Center for Devices and Radiological Health's Office of Compliance, I provide my knowledge to the FDA regulated industry, law firms represnting people who have been injured or killed by FDA regulated products, etc. I consult in the areas of CGMP requirements of the Quality System Regulation, Medical Device Reporting (MDR) regulation, premarket applications, etc.
Education
long island university
louis kaufman's Contact Information
Phone
Find the Right Leads
Find Verified Contact Data
What LeadContact does well
Find verified emails, phone numbers, and decision-makers with 98% accuracy.
Find Leads
Find the right people by company, role, industry, location, and more.
925M+ professional profiles
Find Emails
Access verified email addresses for your target contacts.
657M+ emails
Find Phone Numbers
Get cross-validated phone data from multiple top sources.
239M+ phone numbers
More Accurate. Lower Cost.
Find contact data in 1 tool with 98% accuracy
LeadContact integrates leading enrichment tools to deliver more accurate contact data—without paying for each one.
Great conversations start with the right contact.
It’s time to find yours.