Process Validation Principles and Protocols

Date: Monday October 23, 2017

Time: 1:00 PM ET | 10:00 AM PT

Duration: 90mins with Q&A

Webinar Description:

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 recommendations for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.

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Jeff Kasoff, RAC, CMQ/OE

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.

Date: Monday October 23, 2017
Time: 1:00 PM ET | 10:00 AM PT
Duration: 90mins with Q&A

Topics covered in this webinar:

  • 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 Should Attend:

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
Single Registration
Single Attendee: $195.00 + HST CAD per session
Single attendee refers to single participant at a single computer/login.

Group Registration
Group of 5 or less per location: $400.00 + HST CAD per session
Group of 6 to 10 attendees per location: $750.00 + HST CAD per session
Group of 11 to 20 attendees per location: per location: $1250.00 + HST CAD per session
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.

Please contact us at for multiple-location group rates or any other enquiries.

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