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Process Validation for Medical Devices

solutionImplementing principles and practices that are consistent with the current FDA guidelines and expectations does not have to be an overwhelming process. Our "to the point" training takes the mystery out of FDA requirements and provides you with common sense, cost effective approaches for your Process Validation efforts.

Launsby Consulting offers Public Seminars, Webinars, In-House Training, Design of Experiments for Process Validation, Phone Consulting, and eLearning Courses.

Our training teaches you how to focus your validation efforts on the most appropriate aspects of your system. Get the confidence you need to meet FDA requirements!

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Public Seminars

Attend and learn the principles and application of successful, cost effective process validation. Whether you are new to process validation or want to refine and improve your existing program, you will benefit from this informative, practical seminar. You will learn how the curent FDA regulations, interpretations and guidelines affect you and how to develop a validation program consistent with compliance and business success.

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Webinars

The reasons medical device manufacturers need to perform process validation are two-fold. The first reason is to satisfy FDA requirements. Although this alone would be a sufficient reason, another key reason to perform process validation is to ensure BUSINESS SUCCESS! We can show you how to comply with FDA requirements and reduce cost and reduce risk.

Unlike many webinars, you will be the only attendee during the presentation. This allows you to get one-on-one time with the instructor and ask questions specific to your industry. We can schedule the webinar to best suit you needs.

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In-House Training

Want a more customized approach to your training? All of our In-house training courses are customized to your specific business processes. We custom create each set of course materials to benefit the customer. We blend actual case studies from your company with theoretical topics from your industry and discuss how they relate to your specific process validation challenges.

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DOE for PV

Learn how design of experiments can enhance your Process Validation activities. Launsby Consulting has been teaching design of experiments techniques to medical device companies for over 20 years. As early as 1990, we were the leading advocates of design of experiments for process validation. In 2004, the GHTF guideline on process validation was released to industry. It highlights the use of design of experiments and Taguchi Methods as a leading mathematical tool for validation initiatives.

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Phone Consulting

Got a question about medical device process validation? We can help. Our panel of experts has over 100 years of combined hands-on experience in a diversity of technologies. any question in this field is fair game. No question is too big or too small.

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eLearning

If you would like to learn about Process Validation at your own pace and on your own schedule, consider enrolling in our Process Validation On-Line Course.

Although this course can be beneficial to those outside the injection molding world, the examples are all specifically related to plastic processes.

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Customers

Here is a partial list of some of the satisfied customers that have benefited from our training.

  • Medtronic
  • Abbott
  • Accuray
  • Optos
  • Synthes
  • CEA
  • Johnson & Johnson
  • Roche
  • Ventana Medical
  • Unilever
  • CSI
  • B. Braun
  • Convatec
  • Medrad
  • Millipore
  • West Company

 


Process Validation Articles by Robert Launsby

 

If you have any questions, please feel free to email us at or call us at 1-719-282-1143.

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