Saturday, September 24, 2016

Advanced cGMP Training - Root Cause Analysis & Deviation Investigation Reports

Advanced cGMP Training
Advanced GMP Training - Root Cause Analysis & Deviation Investigation Report Writing

Pinpointing the wrong cause (for example, a "false" root cause) can result in ineffective immediate, corrective, and preventive actions.
  • Throwing fixes at the wrong things might not fix the problem.
  • Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis.
By taking our advanced courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

These highly popular advanced cGMP training classes are taught at the location of your choice. You might be interested in two of our highly inter-related courses.

Root Cause Analysis for Better Deviation Investigations: On-site Advanced GMP Training by SkillsPlus International Inc.  
     Course Objectives:
  • Use tools and techniques to effectively identify the deviation statement
  • Identify the root cause of the deviation. 
  • Generate and objectively select the best corrective and preventive actions.
  • Assess the risk of implementing the corrective action and preventive action.
  • Develop a contingency plan to preventive action implementation.
  • Create corrective actions and preventive action metrics. 
Deviation Investigation Reports: On-Site Advanced GMP Training by SkillsPlus International Inc.
      Course Objectives:
  • Increase investigation report suitability for FDA review. 
  • Decrease the number of reports returned by internal reviewers. 
  • Write supported deviation statements. 
  • Provide a detailed background statement to include related information, investigations, affected materials and references. 
  • Document deviation investigation findings. 
  • State the root cause with supporting facts. 
  • Generate supported, plausible, and defensible corrective actions. 
  • Develop effectiveness measures for the corrective actions. 
  • Generate realistic preventive actions. 
  • Develop effectiveness measures for the preventive actions. 
  • Develop a follow up plan for corrective and preventive actions. 
  • Write accurate executive summary statements. 
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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Tuesday, September 20, 2016

Advanced cGMP Training Courses & Classes

Advanced GMP Training

Advanced GMP Training Workshops & Seminars

SkillsPlus International Inc. offers both advanced and basic GMP training courses and classes. While serving over 350 clients and customers world-wide (in the pharmaceutical, biotech, and medical device industries), it is our mission to provide quality training and consulting services that meet the needs of the client organization.

Do you have an advanced cGMP training need?  Then give us a call to see how we can help you:  (415) 948-5220.

Learn more about SkillsPlus Intl Inc.'s principal course instructors


Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

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