- Root Cause Analysis for Better Investigations, and
- Deviation Investigation Reports
Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.:
"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'via Blog this'
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."
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Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.:
Purpose:
- To use the data collected in an investigation to write a report and answer management and FDA questions.
- 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.
- In-house deviation reports will be used to demonstrate and practice the skills and principles of this class.
- This course is best taught in a computer lab. We can ship computer labs to your site if needed.
- This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.
- The optional final exam is approximately 25 questions.
- Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.
- This class can accommodate up to 12 people.
- Duration: 8 hours as a minimum.
- Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.
- Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.
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