Course Code: CPD/O/12/2021
CPD Hours: 14
Effective deviation management is essential for maintaining productivity and GMP compliance, yet many investigations rely on “human error” conclusions that lead to repeated retraining without addressing deeper behavioural or systemic causes. This often results in recurring non-compliances.
This course introduces Behavioural GMP (bGMP) as a practical approach to understanding and preventing non-compliance by addressing human behaviour, error types, and the limitations of retraining alone.
Day 2 focuses on Data Integrity (DI), a core regulatory expectation and key element of an effective Quality Management System. Participants will explore DI principles, global expectations, and practical methods to ensure reliable data across QC and operational activities through real-world examples and case studies.
Content
Day 1: Behavioural GMP & Managing Deviations
- Root causes of product defects
- Human error types and underlying causes
- Behavioural drivers leading to non-compliance
- Managing errors and non-compliant behaviours
- Human learning stages and related error patterns
- Identifying behavioural and systemic contributors
- Building a strong quality culture and reducing recurring issues
- Leadership roles in reinforcing compliance
- Strategies to minimise learning and inherent errors
- Targeted approaches for preventing future errors
Day 2: Data Integrity
- Core principles and contributors to Data Integrity
- Regulatory expectations for data governance and security
- Assessing data criticality, risk, and controls
- Embedding DI into the QMS using a risk-based framework
- Protecting raw data and original records
- Practical DI audit techniques, detection methods, and remediation strategies
Participants
Managers and supervisors responsible for GMP compliance, reducing deviations, conducting failure investigations and continuous improvement will benefit from this program.
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 | 24 February 2026 | 9:00am-5:00pm |
| Day 2 | 25 February 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.
