Investigations
BASIC Options
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Interactive workshop on how to investigate deviations, including practical root cause analysis, that reduces recurrence
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Interactive workshop on writing deviation reports, investigations and CAPA (Corrective and Preventive Actions) that will withstand regulatory scrutiny and improve right-first-time
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Investigation execution and report writing, including conducting investigations, root cause analysis, and CAPA planning
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Investigations/CAPA review and recommendations for improvement
HOLISTIC Options
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Rubric to qualify investigators and measure effectiveness of deviation reports and corrective actions
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Work with company stakeholders to establish deviation forum to triage deviations daily
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Develop error decision trees to reduce ‘operator error’ root cause
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Develop and implement rapid response program to gather data and problem solve deviations in hours, not days or weeks
What VALUE can we bring to your organization?
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This methodology has improved RFT for investigation authors from ~25% to >80% at large commercial pharma company
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Decreased recurrence and overall number of deviations.
Testimonial
I enjoyed the course very much. It was interesting - lots of very good information and thought-provoking ideas - dynamic, interactive. And even though I'd been dealing with deviations for many years, I still learned a lot from you. You are a great instructor.
-Eva M., Director of CMC Quality
Course: Investigations & CAPA
Title: Investigations/CAPA
Description
The target audience of deviation reports, unlike SOPs, includes management, QA, auditors, regulatory inspectors, and partners. Training employees how to write clear, concise descriptions, impact assessments, CAPAs and investigation findings that demonstrate a logical thought process and stand alone without interpretation is a challenging but essential skill for every FDA-regulated firm.
Part I is Initiator training; Part II is for Investigators and Approvers. Both parts include roles, responsibilities, and best practices for executing deviations, as well as how to write a clear, concise, logical report that will withstand regulatory scrutiny.
Course includes:
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consequences of poor investigations
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high-level process
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key critical thinking elements
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tips and best practices for finding true root cause, and resisting the urge to blame ‘operator error’ and use retraining as a catch-all CAPA.
The session follows a real-world biopharma case study through the entire session, that trainees will participate in investigating.
Duration:
Two parts: Initiator = 2 hours; Investigator = 4 - 6 hours
Note: All courses can be offered in person or in virtual format using MS Teams.
