This class is instructor-led, and is taught at client manufacturing plant locations.
Purpose:
This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions. Students learn how to summarize the important points of the investigation that support the root causes.
Objectives:
Upon class completion, students will be able to:
- Increase investigation report suitability for FDA review.
- Decrease the number 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.
- Incident description
- Investigations and affected materials
- Deviation investigations
- Corrections (path forward)
- Corrective actions
- Preventive actions
- Background information
For more information, visit:
SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
Additional Keywords: cGMP, GMP, QSR, live,onsite,on-site,in-plant,plant,instructor-led,training,class, course, FDA, deviation, investigation,reports, CAPA, SkillsPlus
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