This course aims to develop contemporary understanding of process validation (PV) in order to comply with regulatory expectations. In addition, it reviews the objectives and standard practices. and provides practical directions on how to use quality risk management principles to prepare validation plans that meet current regulatory expectations.
Content
Day 1: The Principles of Process Validation
- The GMP reasons for process validation.
- Statistical process control and process validation
- Regulatory basis for process validation
- Strategies for process validation that complies with GMP
- Essentials of a process validation protocol
- FAQs and case studies based on regulatory observations
- Requirements for re-validation and give examples of situations that would give rise to it
- Current industry trends
Day 2: The Practices
- Workshops exploring common PV problems and solutions
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 | 20 May 2024 | 8:45am join for 9am-5pm |
| Day 2 | 21 May 2024 | 8:45am join for 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
To register, please contact us at solutions@seerpharma.com
Contact us for clarification or to discuss your interest in this course.
