Master the essential steps in cleaning validation and ensure product quality and patient safety
Cleaning validation is critical in the pharmaceutical and MedTech industries, ensuring that approved cleaning processes effectively remove contaminants to safe levels. This is a comprehensive, interactive course on regulatory requirements, process design, and risk-based strategies for cleaning validation. This course equips you with the knowledge and tools to confidently navigate regulatory expectations, mitigate risks, and maintain product quality.
The course provides the expertise and practical tools you need to confidently tackle cleaning validation challenges, ensuring your processes safeguard both product quality and patient safety.
In this course, you will:
- Gain an understanding of the regulatory requirements for cleaning validation, including Eudralex Vol.4, Annex 15, and FDA regulations.
- Learn the key stages of the cleaning validation process, including planning, protocol development, cleaning, sampling, testing, and documentation.
- Explore how to design an effective cleaning process and introduce the concept of Maximum Allowable Carryover (MACO), including how to calculate it.
- Understand how to focus efforts on risk reduction during the validation process while implementing a risk-based approach to monitoring.
- Learn how to set up an effective monitoring program and establish periodic reviews to ensure ongoing compliance.
- Gain insights into the documentation requirements for cleaning validation, including where and how everything should be recorded.
This full-day course will feature presentations on the regulatory framework, trends, and focus areas from authorities, balanced with practical hands-on workshops on cleaning process design, the cleaning validation lifecycle, and proper documentation and reporting.
Tailored to Your Needs: This course is customizable to address your organization’s specific needs, allowing for tailored discussions that maximize relevance and impact.
Target group: This course is designed for staff in R&D, production, and quality assurance who are involved in cleaning validation.