Auditing is a core element of an effective Quality Management System (QMS) and a key driver of sustained regulatory compliance. Beyond meeting self-inspection, internal audit, and supplier oversight requirements, well-executed audits strengthen accountability, improve process understanding, and support continual improvement across the organisation.
This course provides a practical framework for planning, conducting, and following up on internal and external audits. Participants will learn to apply risk-based auditing techniques, gather and document objective evidence, and translate audit findings into meaningful CAPA that strengthen the QMS and stand up to regulatory scrutiny.
Content
Day 1 – Internal, External & Supplier Audits
- Role of audits in maintaining QMS effectiveness
- Regulatory frameworks and audit expectations
- Risk-based audit planning and scheduling
- Audit preparation, scope definition, and checklist development
- Evidence collection techniques: document review, interviews, and walkthroughs
- Auditor skills, communication, and professional conduct
- Writing clear, defensible audit findings and classifying observations
Day 2 – CAPA & Audit Lifecycle Management
- CAPA purpose and regulatory expectations
- Linking audit observations to effective corrective and preventive actions
- Risk-based assessment of audit findings
- Root cause analysis and development of SMART CAPAs
- CAPA verification and effectiveness checks
- Establishing a closed-loop audit and CAPA process
- Inspection readiness for audit and CAPA systems
Participants
This course is designed for all operational staff who are involved in audits, for example, Quality Assurance, Quality Control, Manufacturing, Validation, and Engineering personnel.
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 | 18 November 2026 | 9am-5pm |
| Day 2 | 19 November 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 and Discount
- SGD $1,400 (excluding tax) per participant.
- A 10% discount applies to 3 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 and we'll contact you.
Contact us to discuss your interest in a public or private delivery of this course.
