Learn about the basics of risk-based quality systems, analysis techniques and practical tips using case studies in this 90-minute audio conference.

1. Presenter
Dr. Mukesh Kumar
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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