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Process
Validation for Medical Devices - Webinar
Date:
Flexible - per your schedule
Presented by: 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
- 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
- When to Validate?
- Elements
of Process Validation
- Types of
Validaton
- Prospective
- Concurrent
- Retrospective
- Revalidation
- Processes
Which Should Be Validated
- Processes
Which May Be Verified
- Validation
Master Plan
- What are
the Steps to Validation of a Process?
- Installation
Qualification (IQ)
- Operational
Qualification (OQ)
- Performance
Qualification (PQ)
- Key Statistical
Tools to Supplement Your Efforts
- What can
go wrong? How to resolve in an acceptable manner.
- Conclusion
About
the Presenter
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.
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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