Course Code: CPD/O/07/2021

CPD Hours: 14

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.

Mostly Asian Business Team

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

Participants will attend both full-day sessions.

 Sessions  Dates  Times
 Day 1  18 November 2026  9:00am-5:00pm
 Day 2  19 November 2026  9:00am-5:00pm

Seats are limited: Only 25 participants per class

Fee
  • HKD $4320 per participant
Course Registration and Payment

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Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions