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


Instructor: Roosevelt Fleurant
Product ID: 705689

  • Duration: 60 Min
This equipment cleaning validation webinar will explain cleaning validation program steps, cleaning agents selection, documentation, cleaning method set up and how to reproduce cleaning validation program and various simple but powerful tools for achieving an in-depth Cleaning Validation Program, and continuous monitoring that meets FDA expectations.
Last Recorded Date: Apr-2018


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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
Instructor Profile:
Roosevelt Fleurant

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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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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