Saturday, February 18, 2012

Root Cause Analysis for Better Investigations - Live onsite cGMP & QSR training class

Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

Learn how to conduct better investigations and address CAPA regulatory requirements.  This is an instructor-led live training class, taught on-site at client locations.

Purpose of this live class: 

  • Teaches students how 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 for this onsite training: 
     Upon course completion, students will be able to . . .

  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. 

Course topics include: 

  • Deviation statement 
  • Deviation investigation 
  • Root cause analysis 
  • Corrective actions 
  • Preventive actions 
  • Risk analysis 
  • Metrics 

For more course information: 
Root Cause Analysis for Better Investigations - onsite cGMP & QSR training by SkillsPlus International Inc.

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