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Process Validation for Medical Device Compliance - Online Webinar

Wednesday, May 24, 2017 at 9:30AM - 12:30PM

Online Event

  • May 2017

    24 Wed

    9:30AM

  • May 2017

    24 Wed

    12:30PM

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Process Validation for Medical Device Compliance - Online Webinar

Wednesday, May 24, 2017 at 9:30AM - 12:30PM

Fremont, CA

No tickets available

Description
The FDA finds inadequacies in process validation with Medical Device firms frequently. In fact, the fourth most frequently-cited Form 483 observation for medical device firms is for Process Validation. Find out how you can avoid these observations and emerge from your FDA audit with zero observations! Medical device validation can be confusing, but this webinar will clear many of the misconceptions related to process validation for medical device companies and helps you to bring your validation program to ship-shape!

Objectives Of The Presentation
  • The attendee will receive an overview of validation, the key elements (DQ/URS, IQ/OQ/PQ and PV) and understand how these validation elements relate to one another
  • The attendee will relate the requirements of process validation back to specified parts of Code of Federal Regulations, to assure compliance with the law
  • The attendee will learn the medical device validation guidance requirements and the apparent discrepancy with pharmaceutical validation
  • The attendee will be able to distinguish Validation from Verification
  • The attendee will understand key differences between the major elements of medical device validation and pharmaceutical validation practices
  • The attendee will learn how to maintain a continual validation state for devices and compare/contrast continual validation with the pharmaceutical notion of continuous process verification
  • The attendee will understand other validation elements that support Process Validation to contribute to an overall comprehensive medical device validation program
Why Should you Attend
The requirements for process validation for medical devices can be confusing, because the correspondence between medical device validation and pharmaceutical validation actions seem to contradict with one another. This webinar will point out the similarities and differences to put your process validation in ship-shape, so you can pass a validation audit for a medical device manufacturing facility.

Areas Covered
  • IQ/OQ/PQ
  • Process Validation
  • Characterization vs. Engineering Studies vs. OQ
  • Difference between GHTF guidance and ASTM E2500 approaches to process validation
  • The importance of sound statistical techniques
  • Leveraging pharmaceutical guidance to demonstrate that your process maintains a validated state
  • Other validation topics
Who will Benefit
  • Engineers
  • R&D personnel
  • Quality Assurance personnel (Technicians, Managers, Directors)
  • Statisticians
  • Manufacturing Engineers
  • Process Engineers
  • Quality Managers
  • Quality Engineers
  • Regulatory Professionals
  • Production Managers
  • Risk Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners
For Registration
http://onlinecompliancepanel.com/webinar/MEDICAL-DEVICE-COMPLIANCE-502356/MARCH-2017-ES-EZEVENT

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