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Process
Validation for Medical Devices - Webinar
Date:
Flexible - per your schedule
Presented by: Robert Launsby or Bruce Tive
Presentation time: 2 hours
Cost: $399.00
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!
Attend
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.
Who
Should Attend?
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.
System Requirements:
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
log-in.
Webinar
Outline
- Brief History
of Validation
- Does Your
Company Need to Do Process Validation?
- Process Validation
Lifecycle
- Definitions
- What is
Process Validation?
- Verification
- Objective
Evidence
- Process
Validation Protocol
- Validation
Economics
- How to Comply in a Cost-Effective Manner?
- What is a Validation Master Plan (VMP)?
- Why VMP is key.
- Elements
of Process Validation
- Types of
Validatons
- Prospective
- Concurrent
- Retrospective
- Revalidation
- Processes
Which Should Be Validated
- Processes
Which May Be Verified
- What are
the Steps to Validation of a Process?
- Installation
Qualification (IQ)
- Operational
Qualification (OQ)
- Performance
Qualification (PQ)
- On-going Control
- Key Statistical
Tools to Supplement Your Efforts
- What can
go wrong? How to resolve in an acceptable manner.
- Conclusion
About
the Presenters
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.
Contact:
For further information or questions, please contact Launsby
Consulting at 1-719-282-1143.
To
Order:
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.
Click
Below To Order
No Risk Money Back Guarantee!
If you are not completely satisfied with our webinars(within
15 days of the webinar), simply call us and receive a 100%
refund! No questions asked! All courses are totally risk free!
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