1000+ Sessions conducted on USFDA,EMA and APAC

Equipment Validation, Tracking, Calibration and Preventive Maintenance

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

FDA Labeling Requirements for Medical Devices

Sheila J. Ramerman, RAC

Founder

Complaint Handling in Compliance with FDA and ISO Regulations

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

FDA PMA Submissions - Contents, Process, Pitfalls

Sheila J. Ramerman, RAC

Founder

How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

FDA Medical Device Regulation - Unique Device Identifier Requirements

Sheila J. Ramerman, RAC

Founder

Supplier Management in FDA-Regulated Industry

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

International Seminar on Corrective And Preventive Action In FDA Regulated Industry

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

International Seminar on Complaint and Adverse Event Management

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

International Seminar on How To Respond To FDA 483s

Brian G. Nadel

President

International Seminar on FDA Inspections in the 21st Century

J. Lawrence Stevens, RAC

FDA Regulatory Expert

International Seminar on How FDA Trains Its Investigators to Review CAPA

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs