The FDA's Industry Guidance document "Validation of Cleaning Processes (7/93)" stood alone for virtually 20 years. Since then and particularly in the period 2016-2020, we have seen significantly more guidance being published from key industry bodies including the EMA, PIC/S, PDA, ISPE, and WHO. But what do all these documents mean for you and your company?
This training course will help you understand the current 'cleaning validation landscape' by discussing the recent changes in regulatory expectations and what they mean for manufacturers. You will also gain insights into the modern application of a science- and risk-based approach to cleaning validation and be able to develop GMP-compliant cleaning validation (CV) protocols.
The agenda for this course will cover:
- Setting Residue Limits
- Develop the Cleaning Process
- Cleaning Validation Strategies
- Sampling Methods
- Analytical Methods
- Writing Protocols
- Maintaining the Validated State
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.
|Day 1||30 October 2023||8:45am join for 9am-5pm|
|Day 2||31 October 2023||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 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
To register, please contact Biju Kishor at firstname.lastname@example.org
Contact us to discuss your interest in a public or private delivery of this course.