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Other Links:
GMP Top 20 Observations Countdown
GLP Guides ISO 17025 M&E Part 11 Quality QSR Qualstar Sampling Suppliers Training Validation
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Root
Cause Analysis for Better Investigations
Purpose
To
conduct or facilitate an individual or team-based investigation that solves
problems and gets results, and complies with FDA expectations in the
pharmaceutical and biotech industries. Objectives
1.
Use
tools and techniques to effectively identify the deviation statement. 2.
Identify
the root cause of the deviation. 3.
Generate
and objectively select the best corrective and preventive actions. 4.
Assess
the risk of implementing the corrective action and preventive action. 5.
Develop
a contingency plan to preventive action implementation. 6.
Create
corrective actions and preventive action metrics. About
the Class
1.
This
class uses current deviations to practice the techniques taught. 2.
The
optional final exam is approximately 25 questions. 3. Each student receives a student guide containing a representation of the program’s
slides and graphics with space provided for note taking. 4.
This
class can accommodate up to 25 people. 5. Duration: 8 hours. Course Topics
To speak with the lead instructor for this class please call Allan Dewes at 415.487.3500 or submit the information request.
©2010 SkillsPlus International Inc. Advancing the Competitive Edge
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