Healthcare

Documenting a Risk-Based Quality System - for Compliance and Cost-Savings

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1. Presenter Dr. Mukesh Kumar Follow us : Risk-based quality systems are the core requirement of all FDA-regulated organizations. These systems aim to reduce the overall…
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  • 1. Presenter Dr. Mukesh Kumar Follow us : Risk-based quality systems are the core requirement of all FDA-regulated organizations. These systems aim to reduce the overall incidences of risk events and adequately manage those risk events that occur, to minimize their impact on the overall functioning of an organization.
  • 2.  Elements of a risk-based quality system  Related FDA regulations and guidance documents  Documentation required by FDA  Automated and manual documentation systems  Reports due to FDA  What is subject to audit and what is optional 2
  • 3. 3 Corrective & Preventive Actions Equipment & Facility ControlsMaterial Controls Management Design Controls Production & Process Controls Records, Documentation, & Change Controls
  • 4. To see the complete presentation check the below link: http://www.audioeducator.com/pharma-biotech/risk-based-quality-system-10- 07-2014.html
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