BASIC Options

Interactive workshop on how to investigate deviations based on industry best practices, including practical root cause analysis, a simple but effective investigation process, and CAPA planning to prevent recurrence
Includes writing deviation reports, investigations and CAPA (Corrective and Preventive Actions) that will improve right-first-time, stand alone, and withstand regulatory scrutiny
Investigations/CAPA review and recommendations for improvement

HOLISTIC Options

Investigation Scoring Rubric, customized to your QMS and procedures, to qualify investigators and measure effectiveness of deviation reports and corrective actions
Human Error Root Cause Interview and Decision Guide to reduce ‘Operator Error’ root causes
Work with company stakeholders to establish deviation forum to triage deviations daily
Develop and implement rapid response program to gather data and problem solve deviations in hours, not days or weeks
Investigations & CAPA Train-the-Trainer to prepare your firm’s internal trainer(s) to sustain the course

What VALUE can we bring to your organization?

This methodology improved RFT for investigation authors from ~20% to >80% at large commercial pharma company
Decreased recurrence and overall number of deviations
Inadequate investigations is a leading source of FDA citations every year; this service provides stronger compliance, and greater trust with regulatory authorities, and reduces risk to patient safety and product quality
Prevention mindset, instead of always reacting to problems

Investigations & CAPA Service

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

View testimonials

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 standalone 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 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:

Consequences of poor investigations
High-level process
Key critical thinking elements
Demystifying the fishbone
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 throughout 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.

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