Course Code: CPD/O/06/2021
CPD Hours: 14
This programme provides a comprehensive introduction to modern equipment qualification and validation practices. Over two days, participants will learn how to apply a structured, science-based, and risk-driven approach to planning, executing, and sustaining qualification activities throughout the equipment lifecycle. The course highlights how effective validation programmes support process reliability, improve operational efficiency, reinforce regulatory compliance, and ultimately safeguard patient safety. Participants will also gain insight into current industry expectations, emerging regulatory trends, and practical tools for making sound validation decisions and producing defensible documentation.
Content
Day 1 – Validation Fundamentals & Risk-Based Application
- Regulatory expectations and the scope of qualification and validation
- Lifecycle-based validation: design through retirement
- Validation planning, documentation, and protocol structure
- Integration of validation with the Pharmaceutical Quality System (PQS)
- Building a risk-based validation strategy using QRM
- System classification and identification of critical functions
- Application of risk tools (e.g., FMEA, HACCP) to define testing scope, sampling, and acceptance criteria
Day 2 – Practical Execution & Lifecycle Management
- Equipment qualification framework and key requirements
- Developing effective User Requirements Specifications (URS)
- Qualification stages (IQ, OQ, PQ): execution, documentation, and assessment
- Risk-based testing and management of qualification deviations
- Change management, periodic review, and requalification triggers
- Strategies for maintaining the validated state and ongoing verification
This course has been designed for validation professionals as well as those involved in approving validation plans and projects. It also applies to anyone interested in GMP and the latest trends and methodologies in validation that are rapidly becoming industry standards.
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 | 9 June 2026 | 9:00am-5:00pm |
| Day 2 | 10 June 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.
