Validation for Medical Devices - Webinar
Flexible - per your schedule
Presented by: Jayme Lahey
Presentation time: 2 hours
Cost: $399.00 for first attendee (+ $50 for each additional attendee)
Includes eBook "Straight Talk on Process Validation"
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
this webinar and learn the principles and application of successful
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 webinar. You will
learn how the current FDA regulations, interpretations and
guidelines affect you and how to develop a validation program
consistent with compliance and business success.
Professionals directly involved in the development and manufacturing
of medical devices and meeting the FDA's quality system requirements.
Individuals associated with regulatory affairs, quality assurance,
process development or manufacturing will find this informative
webinar extremely valuable.
Attendees will need high speed internet access and audio.
The webinar will be run with GoToMeeting software. A quick
(approximately 2 minute) install will be needed to view the
webinar. This may be done during registration or upon webinar
- Brief History
- Does Your
Company Need to Do Process Validation?
- Process Validation
- What is
- How to Comply in a Cost-Effective Manner?
- What is a Validation Master Plan (VMP)?
- Why VMP is key.
of Process Validation
- Types of
Which Should Be Validated
Which May Be Verified
- What are
the Steps to Validation of a Process?
- On-going Control
- Key Statistical
Tools to Supplement Your Efforts
- What can
go wrong? How to resolve in an acceptable manner.
Bruce Tive is a Group Manager at a major medical device company.
Bruce has over 30 years of medical device experience at various
medical device companies in the areas of manufacturing engineering,
packaging and validation. Bruce has a Master's of Science
in Quality Assurance. He has trained engineers, product managers,
and product development engineers in the various aspects of
validation. His interactive style will help you grasp the
material and feel confident in its application.
Robert Launsby has taught thousands of students Design of Experiments techniques and hundreds in the area of Six Sigma. Bob has consulted with numerous companies in the area of FDA protocols for Process Validation. He is co-author of "Process Validation for Business Success", "Design for Six Sigma", "Engineering Today's Designed Experiments", "Understanding Industrial Designed Experiments" and "Experimental Design for Injection Molding". Bob's presentations are lively and informative. His examples are practical and thought provoking.
For further information or questions, please contact Launsby
Consulting at 1-719-282-1143.
Price is $399.00. Call Launsby Consulting at 719-282-1143
or click on the button below. You will then be contacted regarding
what date and time work best for you
to attend this webinar.
Below To Order
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