Process Validation Principles and Protocols for Medical Devices

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $275.00
  • Refund Policy

Overview:

The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit.

Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes. This webinar explains the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.

Why You Should Attend: Compliance with process validation requirements results in cost savings and quality product. A robust process that has undergone complete validation provides a high degree of confidence that product will meet specifications. However, medical device professionals continue to struggle with process validation.

Areas Covered In the Seminar:
  • What is Validation?
  • When should it be used?
  • How does it differ from verification?
  • Validation vs. Verification: Which One?
  • Protocol preparation
  • Different types of validation
  • IQ, OQ, and PQ
Who will benefit: This webinar is targeted toward professionals involved in meeting FDA's Quality System Validation requirements:
  • Validation Specialists/Managers
  • Process Engineers
  • Manufacturing Engineers
  • Quality Engineers
  • Product/Process Development personnel
  • Research and Development personnel
  • Quality/Regulatory Personnel
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is multi-facility oversight of the CAPA system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.


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