Based on our extensive training experience in the FDA Medical Device space, we are available to assist clients with training opportunities as follows:

  1. 21 CFR 50 AND 56, 21 CFR 812, 21 CFR 820 Basic Requirements
  • Domestic and International companies
  1. FDA Quality System Inspectional Technique (QSIT). Mock FDA Inspections of medical device companies
  1. FDA Inspectional readiness in all program areas (medical devices, principal investigators, sponsors, CROS)
  1. FDA-483, Inspectional Observations and Warning Letter Responses
  1. Internal auditor training to “inspect” like the FDA Investigators
  1. CAPA implementation including root cause analysis
  1. Design control development and implementation
  1. Assistance in the development of client specific training

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