Free cGMP Tip on Root Cause Analysis (RCA)

Free cGMP tip on RCA

Free GMP Tip for Root Cause Analysis

Free GMP tip on root cause analysis (RCA)

The FDA says, “Human error is not a root cause.” If your first reflex is blaming human error, it’s time to re-think the situation in order to identify the real root cause of the human error.

There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis.

Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).

Learn more about this topic by taking these courses by SkillsPlus Intl Inc:
Root Cause Analysis for Better Investigations – A cGMP QSR GMP Training Course
Deviation Investigation Report Writing – A GMP QSR cGMP Training Workshop

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website

Advanced GMP Training – Root Cause Analysis & Deviation Investigation Reports

Advanced GMP Training

Advanced cGMP Training

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

Pinpointing the wrong 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 popular and 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.

You might also be interested in:
GMP Training – Live, onsite courses taught by SkillsPlus Intl Inc.


Go to www.GMPprof.com – Our GMP E-learning & Multimedia Resources website