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Straight Talk Blogs. Quick links. HCL Technologies. Process Validation. Process Validation Over the recent years, the Process validation activity is being taken seriously in the medical device industry. You must have JavaScript enabled to use this form. Virgin Islands American Samoa. Request a meeting. Preferred Communication Mode Email. Anonymous 0. Was this answer helpful? Yes No. This answer closely relates to:. Suggested Solutions 10 What's this?

Process Validation for Medical Device Manufacturers

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The FDA has changed its story on whether or not the levels of a possible…

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  8. That person may have confused a "ram" SD card with a sim. One is declaring good product bad. The other is calling bad product good. This strategy will guarantee you have field failures and excessive manufacturing costs. It leads to lots of rework and scrap. It is the antithesis of a low-cost and lean strategy. There are a lot of medical device manufacturers doing an excellent job with their process validation initiatives. They got there by thinking through their products and processes and developing process validation strategies that are appropriate for their unique needs.

    The team then needs to document their logic and decision.

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    You should be the expert on your design and process, not an outside consultant or the FDA. Process validation need not be a painful process. Our belief is that the FDA really wants you to look at process validation from a common sense approach.

    A fundamental tenant being driven at FDA presentations we have attended is:. It is also important to remember that just because your process validation effort is completed does not mean you are done. You must have a system of timely, rigorous controls in place. You must do Process Control! Edward Deming, a noted guru on Quality and Management, stated that getting a process to attain a state of statistical control requires a great deal of team work and effort. This has been our experience as well.

    After the process has been validated, it is key to have on-going statistical process control techniques in place. In this book we will attempt to provide a proactive, logical, thought provoking approach to the process validation, and continued control of a process. Process validation cannot be completed in a vacuum after design work has been completed. It must be part of a proactive, integrated, cross-functional team effort. Individuals need to have a working knowledge of FDA requirements, company Standard Operating Procedures, and profound knowledge of customer needs, product design, and processes.

    Having been involved in validations and Quality Technology Systems like FMEA and SPC for the past few years, and having clients in the injection molding industry, I wanted to thoroughly understand the validation process for the medical industry. I found Bob's book on this topic to be exactly what I was looking for. He has brought out the essence of validation clearly with his lucidly written text. We have been offering our FMEA software predominantly to the automotive industry. The detailed treatment given to FMEA is this book has highlighted the needs of the medical industry very clearly.

    It identifies well with what we have been offering the industry. The book also helped me understand what the FDA requirements are. These are usually not clearly understood by non-US companies. No Risk Money Back Guarantee! US Orders Paperback. Canadian Orders Paperback. International Orders Paperback. If you have any questions, please feel free to email us at Email address protected by JavaScript.