Cleaning Validation

Course Code: CPD/O/04/2021

CPD Hours: 14

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.

Content

• Regulatory basis / GMP reasons for cleaning validation.
• Strategies for cleaning validation that complies with GMP
• Practical limits for cleaning residues and exercises to practice the formulas
• Health based exposure limits
• Essentials of a cleaning validation protocol
• Current industry practices
• FAQs and case studies based on regulatory observations
• New EU requirements for Health Based Exposure Limits (HBELs)

• Workshops exploring common CV problems and solutions

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

Participants will attend both full-day sessions.

Seats are limited: Only 25 participants per class

Fee and Registration

• HKD $4320 per participant

To register, please download the complete the course registration form in either MS Word or PDF 

Refer to the Terms and Conditions