Author
Walid El Azab
Attendees:
This program is designed for professionals involved in ensuring equipment and facility cleanliness in regulated manufacturing environments. Key attendees include personnel from Quality Assurance, Quality Control, Validation, Manufacturing, Engineering, Regulatory Affairs, and Maintenance teams within the pharmaceutical, biotechnology, and API sectors.
Abstract:
This intensive three-day training provides a deep dive into the science, strategy, and compliance requirements of cleaning validation for pharmaceutical and biotech manufacturing. Moving beyond theory, the course focuses on the practical application of a risk-based lifecycle approach, from initial design through to ongoing monitoring. Day one establishes the regulatory foundation and guides participants through the critical stages of cleaning cycle development and equipment design considerations that inherently influence validation success. Day two tackles the core quantitative aspects, including residue limit calculations (MACO, PDE) and the development of sound sampling plans and analytical recovery studies. The final day focuses on maintaining the validated state, covering routine monitoring programs, statistical trend analysis, change control, and the management of requalification or revalidation activities. Through interactive workshops and real-world case studies—such as designing a validation strategy for a multi-product facility or troubleshooting a cleaning failure—attendees will gain the hands-on knowledge necessary to design, execute, and defend a robust, sustainable cleaning validation program that ensures patient safety and meets stringent global regulatory expectations.
Learning Objectives:
Upon completion, participants will be able to:
- Interpret and apply global regulatory requirements (FDA, EMA, PIC/S) for cleaning validation and verification.
- Design and justify effective cleaning cycles for manual and automated processes, including worst-case product and location selection.
- Understand the critical impact of equipment design on cleanability and identify common engineering pitfalls.
- Calculate scientifically defendable acceptance limits for chemical and microbial residues (e.g., MACO, PDE).
- Develop and execute a robust cleaning validation protocol, including appropriate sampling methods (swab, rinse) and analytical method considerations.
- Establish a lifecycle approach to cleaning validation, encompassing routine monitoring, change control, periodic review, and trend analysis to maintain a state of control.
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