Process Validation (PV) is a core requirement in pharmaceutical manufacturing, ensuring processes consistently deliver products of the intended quality. This programme presents a modern, practical approach by integrating regulatory expectations with Quality Risk Management (QRM), science-based evaluation, and lifecycle thinking.
Participants will learn to plan and execute PV using a risk-based, data-driven approach that strengthens process understanding, improves control strategies, and supports long-term process robustness. Through real examples and practical workshops, attendees gain tools to identify risks early, interpret data statistically, and drive continuous improvement—enabling validation programmes that are compliant, efficient, and aligned with current industry expectations.
Content
Day 1 – Process Validation Foundations & Design
- Purpose of process validation within GMP
- Understanding process variation, capability, and sampling concepts
- Regulatory expectations and lifecycle-based PV approaches
- Modern Quality Management perspectives and validation challenges
- Process design essentials: QbD principles, QTPP, CQAs, CPPs, design space, and control strategies
- Linking process design, validation strategy, and continuous improvement
Day 2 – Data Analysis & Validation Lifecycle Management
- Building process understanding to support validation decisions
- Managing and assessing validation deviations
- Applying statistical tools for data analysis
- Evaluating process capability and performance
- Workshops on common PV challenges and practical problem-solving
Participants
This course has been designed for validation professionals as well as those involved in approving process validation plans and projects. It also applies to anyone interested in the latest trends and methodologies in process 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 session 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 | 8 July 2026 | 9am-5pm |
| Day 2 | 9 July 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 $1400 (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.
