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Process Validation for Medical Device Compliance - Webinar

  • ID: 3785815
  • Webinar
  • May 2017
  • Region: Global
  • 60 Minutes
  • Online Compliance Panel
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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

Topic Background

This training focuses on the requirements of 21 CFR 820, with regard to Process Validation, discusses the Global Harmonization Task Force validation guidance, and compares it to validation methodologies commonly practiced in the pharmaceutical industry.
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- 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
Note: Product cover images may vary from those shown
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  • Regina Fullin Regina Fullin,
    Validation Consultant ,
    Compliance Team, Inc.


    Regina Fullin is a Compliance Consultant with Compliance Team, Inc.TM (CTI), where she assists clients in the medical device and pharmaceutical industries to help them achieve ever-increasing compliance to regulations in the pharma, medical device, and related industries. She began her career more than 20 years ago in a Quality role at Abbott Laboratories, and has worked in Quality roles at other companies, including GE Healthcare. Her particular areas of expertise focus on validation, equipment qualification, complaint handling, technical writing and remediation projects for companies requiring compliance assistance. Within her role at CTI, Regina also uses her writing skills to publish relevant and meaningful articles to help medical manufacturers stay current with regulatory changes, industry trends and improve product quality.

    Regina is active in the American Society for Quality (ASQ), an international non-profit organization devoted to serving the needs of quality professionals. Regina is active in the Northeastern Illinois Section (1212) as Programs Chair and is Chair Elect. In addition to her Section involvement, Regina also serves on the ASQ Food, Drug and Cosmetic Division, where she participates in conference/event planning and annual audit. Regina is also a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.

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  • 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
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