The pharmaceutical, biotechnology, and medical device industries operate under strict regulatory expectations, where effective investigation of deviations and quality failures is critical to patient safety and product reliability. One of the most frequently cited inspection findings across FDA, EMA, MHRA, and PIC/S inspections is the failure to conduct thorough investigations.
This course equips participants with practical skills in root cause analysis (RCA), effective investigation documentation, and structured problem-solving approaches that meet regulatory expectations. Through real-world examples, participants learn how systematic investigations prevent recurrence.
The programme also covers the strategic use of CAPA as a closed-loop system for driving sustainable improvements and strengthening the Quality Management System (QMS), aligned with current expectations for risk management, data integrity, and lifecycle management.
Content
Day 1 — Root Cause Analysis (RCA)
- Introduction to structured problem-solving and the 8D methodology
- Comparing 8D with Six Sigma DMAIC and PDCA lifecycle approaches
- Understanding variation and its impact on problem definition and analysis
- Step-by-step walkthrough of all 8D phases, from containment to prevention
- Overview of common RCA tools (Fishbone, 5 Whys, Fault Tree Analysis, Is/Is Not, Pareto, etc.)
- Practical workshop: Develop a complete 8D report using a real investigation scenario
Day 2 — Corrective and Preventive Action (CAPA)
- Review of current regulatory expectations for CAPA (FDA 21 CFR, EU GMP, ISO 13485, PIC/S, ICH Q10)
- Clear differentiation between Corrective Action and Preventive Action
- How CAPA links with key QMS elements: deviations, complaints, audit findings, change control, and risk management
- Applying risk assessment (FMEA, risk prioritization, severity/occurrence/detectability) to CAPA decisions
- Incorporating SMART criteria into CAPA planning and documentation
- Critical components of a compliant, effective CAPA system
- Hands-on exercise: Build a CAPA plan based on RCA findings from the Day 1 workshop
Participants
This course has been designed for all those who are involved in failure investigations and corrective actions. You will benefit from this program whether you are new to formal problem solving and CAPA or are a more experienced professional. It is expected that you are familiar with regulatory GMP and Quality Management System requirements within the pharmaceutical and/or medical device industries.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 2 full day sessions with breaks.
PDF Certificates will be provided to participants electronically.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Sessions
| Sessions | Dates | Times |
| Day 1 | 25 May 2026 | 9am-5pm |
| Day 2 | 26 May 2026 | 9am-5pm |
Times are based on Singapore time (SGT): UTC +8:00.
Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.
Fee
- SGD $1,400 (excluding tax) per participant
- A 10% discount applies to 3 or more participants from the same company
Course Registration and Payment
Pay by credit card at our Eventbrite site: Click here
Pay by invoice: Submit the form below to Request an Invoice and we'll contact you.
Contact us to discuss your interest in a public or private delivery of this course.
