Advances in Cleaning Validation MasterClass - EU edition

This interactive training will provide a comprehensive overview on the lifecycle approach of cleaning validation, including discussions of real-life case studies.

02-03 December, 2026, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

An important measure to mitigate contamination and cross contamination risks in GMP compliant manufacturing of drug products, is cleaning of equipment and facilities. According to current regulations, the scope is much broader than just the cleaning procedure itself. Everything starts with state-of-the-art design of facilities and cleaning-friendly equipment. Based on comprehensive risk assessment, taking into account the manufacturing environment as well as API and product properties, the most challenging (worst case) products and processes should be identifed.

Adequate sampling strategies as well as sufficiently sensitive analytical procedures have to be developed. Criteria which had been traditionally applied to evaluate acceptable contamination levels have been replaced by API-specific health- based exposure limits and calculations of maximum allowable carry over (MACO). Cleaning validation is not a one-time exercise, it has to be followed by continued cleaning verification during product lifecycle. Proper documentation of all cleaning validation lifecycle stages is of paramount importance in the quality management system and frequently will be subject during regulatory inspections.

This interactive training will provide a comprehensive overview on the lifecycle approach of cleaning validation, including discussion of real-life case studies.

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WHO SHOULD ATTEND

-Heads of manufacturing

-Heads of QC

-QA Heads

-QA managers

-Manufacturing managers

-Heads of engineering

-Facility technicians

-QC Managers

-Analytical development specialists

-QA auditors