Equipment Cleaning Validation - Program Setup, Monitoring to Meet FDA Expectations

Why Should You Attend:

One of the most audited area by the FDA is Cleaning Validation, it gives the FDA assurance that your process can continuously produce a product in a clean state as per regulations.

This webinar will cover all topics related to cleaning validation, it will give you an understanding of the entire cleaning process. It will help any manufacturer, and give production, quality and laboratory departments the tools and understanding of the scope on how to start a cleaning validation process and what is required.

We will discuss simple but powerful tools, the systematic and regular use of which, can resolve the key underlying problem of executing cleaning validation protocol and continuous monitoring of critical cleaning parameters (CCPs). The information and tools presented in this webinar can contribute greatly to reduction of product liability, cost reduction efforts, less chance of 483's, and an improved bottom line.

Areas Covered in the Webinar:

• US FDA Cleaning Validation Expectations.
• What are the steps to achieve a Cleaning Validation Program?
• How to determine the worst product to clean in the company's portfolio.
• How to select the right cleaning agent.
• The chronological order of writing all documents related to Cleaning Validation.
• How to group Equipment.
• How to set up a Cleaning Method.
• In depth discussions on clean and dirty hold time studies.
• Ways of assurance that the Cleaning Validation Program is reproduceable.
• Ways of monitoring the Cleaning Validation Program.
• Yearly re-validation of equipment.

Who Will Benefit:

The employees who will benefit include:

• Senior Management
• Production/Quality Assurance Personnel
• Quality Control Personnel
• Engineering
• Research & Development
• All personnel tasks with problem solving

Roosevelt Fleurant
CEO, Fleurant Consulting LLC

Roosevelt Fleurant is the CEO and founder of Fleurant Consulting LLC with over 20 years of extensive practical and management experiences in various Fortune 100 Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Contract Manufacturing Organization (CMO) and Medical Device/IVD companies & Combo Products. He has worked with companies in the US, Europe and Asia.

He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses new/ changed product 510(k)s, process/product/equipment including QMS and validations, ISO 14971 product risk management files/ reports, design control/ design history files, and technical files. He’s held positions in manufacturing engineering, QA, to the level of assistant director of QA.

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