ISPE official training course: Cleaning Validation Principles (T17)

Date

22-23 July 2026 - 9:00 AM – 5:00 PM

Venue

Ambassador Hotel, Bangkok, Thailand

Details

ISPE official training course: Cleaning Validation Principles (T17)

This program is accredited for xx CPE Credits.

T17

Date: 22-23 July 2026

Course Time: 9:00 AM – 5:00 PM

ISPE official training course: Cleaning Validation Principles (T17)

Overview

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. This training course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including  FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.


What You Will Learn

  • Elements of a cleaning validation program from start to finish
  • Exploring such concepts as the determination of residues to be targeted
  • Selection of analytical and sampling methods
  • Determination of appropriate limits in various pharmaceutical and biotechnology processes
  • Establishment of scientific rationales acceptable to regulatory inspectors
  • For mature cleaning validation programs, concepts such as understanding process control, capability
  • Learning to effectively self-audit a cleaning validation program and documentation


Course Modules

  • Regulatory Requirements for Cleaning Validation
  • Goals of Cleaning: Risk and Science
  • Risk Assessment: Risk Identification
  • Risk Assessment: Risk Analysis
  • Risk Assessment: Risk Evaluation
  • Risk Control: Risk Reduction
  • Method Validation and Recovery Studies
  • Documentation for Cleaning Validation
  • Risk Review and Risk Communication


Speaker

Mr. Richard Chai,  ISPE Qualified Trainer for Cleaning Validation Principles Training Course


Registration Fee

  • ISPE/ TIPA Member 8,000 THB
  • Non ISPE/ TIPA Member 12,500 THB


Register to join now!


* Attendance is restricted to a maximum of 40 participants.


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