Cleaning validation has long been a key regulatory focus, with expectations evolving significantly in recent years toward a more science- and risk-based approach. As regulatory guidance has expanded and matured, companies are increasingly challenged to interpret current expectations and translate them into practical, inspection-ready cleaning programmes.
This course provides a clear and practical overview of modern cleaning validation requirements, helping participants understand regulatory intent and apply effective strategies in GMP environments. Through examples, discussions, and workshops, attendees will gain the knowledge and tools needed to design, execute, and sustain a compliant cleaning validation programme that supports product quality and patient safety.
Content
Day 1 – Cleaning Validation Foundations
- GMP rationale and regulatory drivers for cleaning validation
- Designing compliant, risk-based cleaning validation strategies
- Establishing residue acceptance limits, including HBEL-based approaches
- Key elements of a cleaning validation protocol
- Sampling, visual inspection, and testing methods
Day 2 – Practical Implementation & Lifecycle Management
- Interpretation of current global cleaning validation expectations
- Designing effective cleaning processes and equipment considerations
- Residue determination, analytical methods, and limit calculations
- Documentation and inspection-ready recordkeeping
- Common causes of cleaning failures and remediation strategies
- Maintaining the validated state and lifecycle management
- Presenting cleaning validation data to regulators
- Interactive workshops using real-world scenarios
Participants
You will benefit from this training if you are in a position of Quality or Validation Management or directly responsible for preparing and executing cleaning validation studies within a GMP facility.
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 | 5 August 2026 | 9am-5pm |
| Day 2 | 6 August 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 for 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.
