STERIS Master Class: Applied Cleaning Validation

Level

Advanced

Prerequisites

Participants should have prior experience in validation. Basic knowledge of Good Manufacturing Practices (GMP), working in a regulated environment, and quality systems is required. Please contact us if you are uncertain whether you meet these prerequisites.

Format

On-site, practical, including essential theory

Duration

2 days

Cost

$1,881

Overview

This intensive course, presented by industry experts, covers industry best practices, regulatory expectations, and trends in cleaning and cleaning validation. It is designed for biopharmaceutical manufacturers seeking to develop or maintain a high-quality, efficient, and compliant cleaning process. Through a mix of expert instruction, real-world case studies, and hands-on exercises, participants tackle current challenges and gain practical skills they can apply immediately.

Why It’s Essential

The course addresses current biopharmaceutical industry challenges in cleaning and validation and includes case studies, best practices, and hands-on exercises using state-of-the-art bioprocessing equipment at CASTL’s biomanufacturing training facilities.   

Learning Objectives

This program takes a full lifecycle approach to cleaning validation, including process design, qualification, and setting acceptance criteria.

Participants explore cleaning chemistries and learn CIP, COP, and manual cleaning methods, and gain hands-on experience with analytical method validation, sampling techniques, and riboflavin testing. 

The course also covers protocol development, grouping strategies, stainless-steel preservation, and managing bioburden and biofilms. Finally, participants learn how to apply Annex 1 expectations to real-world cleaning programs.

Who Should Attend

This course is designed for individuals in quality assurance, regulatory, quality control, validation, operations, microbiology, facilities maintenance, engineering, and plant management roles.

Participants who successfully complete a theoretical assessment will receive a certificate of completion.