Compliance

Online Training Id: CP-C

Credits: 1.0



USD 399.00

USD 399.00

This module provides you with the compliance rules, regulations, and functions within a pharmaceutical company for both drug and drug products, and medical devices. The module first discusses the different compliance issues specific to drugs and drug products. Then it presents compliance issues specific to medical devices. The information presented here is important to consider when engaging in clinical development or clinical trials within medical affairs.

Learning Objectives:

  • Define Compliance and First Tier quality system related requirements
    • Compliance quality system for Drugs and Biologics
    • Compliance quality system for Medical Devices
  • Describe Compliance and Second Tier related requirements
    • 21 Code of Federal Regulations (CFR) Part 50 – Protection of Human Subjects Domestic
    • 21 CFR Part 56 – Institutional Review Board International
    • 21 CFR Part 58 – Good Laboratory Practice for Non-Clinical Laboratory Studies
  • Organize a plan for the Compliance and Third Tier related requirements
    • CFR Part 7 – Enforcement Policy

Related Courses:
No Authors assigned till now
Online Training Highlights
Duration: 2 hrs
Released On: 10/29/2018
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