Description
Cleaning Validation is a critical requirement in GMP manufacturing to ensure equipment is free from residues, contaminants, and cross-contamination risks.
This Advanced Cleaning Validation Workshop provides a deep, practical understanding of the science, methods, and regulatory expectations behind designing, executing, and maintaining a compliant cleaning validation program.
The workshop goes beyond the basics — focusing on risk-based approaches, lifecycle validation, acceptance limits, sampling strategies, analytical methods, matrix calculations, and troubleshooting failed validations.
Participants will learn how to establish robust, science-based cleaning processes aligned with EU GMP Annex 1 & Annex 15, FDA, WHO, EMA, PIC/S, and ICH Q9/Q10 principles.
Real case studies, calculation templates, and validation protocol examples are used to demonstrate how to build an effective Cleaning Validation Master Plan (CVMP) and how to manage ongoing verification and periodic review.
By the end of this workshop, participants will be able to:
- Design and implement compliant Cleaning Validation programs
- Calculate MACO / PDE / ADE limits using internationally accepted models
- Select appropriate sampling methods: swab, rinse, and visual inspection
- Build scientifically justified worst-case product matrices
- Develop risk-based cleaning validation protocols, reports, and lifecycle documentation
- Manage cleaning failures, investigation steps & CAPAs
- Understand analytical method sensitivity and sample recovery
- Ensure readiness for audits and regulatory inspections
Who Should Attend?
This advanced workshop is ideal for professionals responsible for contamination control and equipment cleanliness, including:
- Quality Assurance (QA) & Validation Specialists
- Production & Manufacturing Engineers
- Quality Control (QC) & Analytical Laboratory Personnel
- Cleaning Validation & Process Validation Teams
- R&D Scientists & Technology Transfer Teams
- Engineering & Maintenance Personnel working with CIP/SIP systems
- Regulatory & Compliance Officers
- Freshly hired entering validation or production roles
- Anyone involved in designing or reviewing cleaning procedures or equipment qualification
Key Takeaways
- Flexible Attendance Options – Join in-person at VALOR or virtually through our live interactive platform.
- Recorded Sessions – Enjoy limited access to recordings for one month after course completion for review and reinforcement.
- Repeat for Free – Participants may re-attend inperson any future round of the same course at no additional cost.
- Accredited Certificate – Receive a QR-coded certificate for authenticity verification and professional recognition.
- Comprehensive Resources – Access digital materials, trainer support, and post-course assessments through VALOR’s e-learning platform.
Course Topics
- Cleaning Validation
- Definition
- Purpose
- Cleaning Design
- Cleaning Methods
- Cleaning agents
- Cleaning parameters
- Grouping strategies
- Worst Case considerations
- Acceptance criteria
- Sampling Methods
- Analytical Methods
- Hold time studies
- Workshop : Creation of protocols for solid line
- Creation of protocols for liquid line.
- Creation of protocols for vial/ampoule line.
Number Of Sessions
4 Session.