Cleaning Validation

For nearly two decades, the FDA's Industry Guidance document "Validation of Cleaning Processes (7/93)" stood as the primary reference. However, in the period between 2016 and 2020, there has been a notable surge in guidance publications from major industry bodies, including the EMA, PIC/S, PDA, ISPE, and WHO. The question then arises: What implications do these myriad documents have for you and your company?

This training course is designed to provide clarity on the current 'cleaning validation landscape' by delving into recent changes in regulatory expectations and elucidating their significance for manufacturers. Participants will not only gain insights into the contemporary application of a science- and risk-based approach to cleaning validation but also acquire the skills to craft GMP-compliant cleaning validation (CV) protocols.

• Regulatory Evolution: Understand the evolution of cleaning validation regulations over the years and the key updates introduced by various regulatory bodies.
• Practical Application: Explore real-world applications of a science- and risk-based approach to cleaning validation, drawing on industry best practices.
• Interactive Discussions: Engage in interactive discussions and case studies to reinforce the understanding of how to navigate the complexities of the updated cleaning validation landscape.
• GMP Compliance: Learn strategies and techniques to ensure that your cleaning validation protocols align seamlessly with Good Manufacturing Practices (GMP) standards.
• Industry Perspectives: Gain insights into industry perspectives on the evolving cleaning validation landscape and how different companies are adapting to these changes.

Content

Day 1: The Principles of Cleaning Validation

• Regulatory basis / GMP reasons for cleaning validation.
• Strategies for cleaning validation that complies with GMP
• Practical limits for cleaning residues
• Health-based exposure limits (HBEL)
• Essentials of a cleaning validation protocol
• Examples from the industry
• Sampling, inspection and testing

Day 2: The Practices

• Current global regulations and requirements for Cleaning Validation
• Cleaning process and method design, equipment design and qualification
• Residue determination, analytical methods and limit calculations
• The documentation used to support an effective cleaning program.
• Common issues and how to deal with failures during the cleaning program.
• How to maintain the validated state
• Know how to present your strategy and data to a regulatory body
• Workshops exploring common CV problems and solutions

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. Participants can be any one from Quality Assurance personnel, Quality Control personnel, Operations and Manufacturing personnel, Qualification & Validation personnel, Engineering and Automation personnel, R&D personnel, or anyone within the GMP industry interested in learning about or improving their knowledge of cleaning validation.

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

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 biju.kishor@seerpharma.com.au 

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions