Trainings By Informa Markets
Informa


11th Edition Cleaning Validation Workshop

09 Sep - 10 Sep 2024
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Workshop Overview

Trainer: Steven A. Weitzel

This two-day course offers a comprehensive exploration of essential cleaning methods vital for maintaining contamination control in the production of regulated medical and health products. Participants will gain insights into the principles of cleaning, emphasizing the removal of undesirable contaminant residues like viable bacteria or non-viable chemical particles. The course will cover various techniques such as Clean-in-place (CIP), ultrasonics, and sterilization, distinguishing between removal and deactivation methods crucial for rendering residues non-active. Special focus will be placed on regulatory requirements related to "Cleaning Validation" to prevent batch-to-batch contamination, a key concern during regulatory scrutiny. Additionally, attendees will learn to evaluate and optimize cleaning processes in accordance with industry standards and regulatory expectations, ensuring compliance while fostering continuous improvement and lifecycle management.

Program Focus

By the end of this course, participants will be able to:

  • Understand the importance and underlying principles of validation of cleaning procedures for drug products and APIs.
  • Understand regulatory requirements and perspectives on cleaning validation and areas of regulatory concern to anticipate and prepare for regulatory inspections.
  • Perform rigorous but sensible contamination control risk assessment and determine the need for health-based residue targets based on ADE, and how to handle extremely bioactive or genotoxic residues.
  • Develop and qualify cleaning equipment and methods with documented understanding and description of process inputs and parameters and documented control scheme.
  • Select, justify and qualify analytical methods and sampling methods to evaluate equipment residue levels.
  • Manage between-batch microbial control procedures and qualifications compatible with but independent of cleaning validation.
  • Plan and conduct cleaning process qualification with practices, protocols and reports that align with current risk-based, life-cycle based process validation principles.

Benefits of Attending


  • Develop and defend your own rigorous but pragmatic cleaning validation plan including rationale and justification for process grouping/matrix and other strategies
  • Use cleaning validation groupings to facilitate and justify new adding new products to existing production equipment without full re-validation.
  • Avoid flawed industry practices that lead to unnecessary activities and overkill.
  • Use cleaning process understanding to facilitate and manage incremental change and process improvement, Tech Transfer, and integration into the Quality System.
  • Identify gaps in your own programs and how to fill them without risk to product quality.

Who Should Attend?


Cleaning Validation is a multi-disciplinary activity that spans many phases of the product life-cycle for all types of healthcare, medical and nutritional products. As a principles and best practices course, there will be value for those new to the topic and value for those with extensive prior experience.

This course will benefit technical and managerial professionals at all levels involved with Process Development, Validation, Tech Transfer, Manufacturing and a range of Quality Assurance functions including QC, GMP compliance, supplier controls, CDMO auditing, and regulatory submissions including:

  • R&D Process engineers
  • Validation scientists and engineers
  • Manufacturing Engineers and Managers
  • Analytical chemists
  • Quality scientists and engineers
  • Quality Assurance
  • Regulatory/Compliance


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