Process Validation - Overview of Why and How

Date: Friday, 20 July 2018 | Time: 10:00 AM PDT, 01:00 PM EDT | Duration: 60 Minutes
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This webinar will provide an understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
Process Validation
Instructor: Betty Lane
Product ID: 507096
Objectives of the Presentation
  • Learn why process validation is necessary
  • Understand what process validation is
  • Learn about process validation guidelines
  • Understand when to validate processes and what processes to validate
  • Understand how to do process validation
Why Should you Attend
Process validation is a requirement but knowing when to validate or revalidate a process is essential. If you do not validate you risk enforcement actions such as fines or recalls, but too much validation is costly in both time and money.

This webinar will cover the basics of this important topic for those who are new to quality or new to process validation. It will:
  • Cover the requirements for process validation from FDA cGMP and ISO 13485
  • Discuss when process validation and revalidation are necessary or desirable
  • Provide an outline of equipment qualification
  • Provide an overview of what is required for process validation
Areas Covered
  • How to determine if a process requires validation
  • Process validation outline
  • IQ - Installation Qualification
  • OQ - Operational Qualification
  • PQ - Performance Qualification
  • Process monitoring
Who will Benefit
This webinar will provide valuable assistance to all personnel in:
  • Quality Engineering
  • Manufacturing engineers
  • Internal auditing
  • Compliance
  • Others in Quality
  • Quality Managers new to medical devices or process validation
  • Operations/Manufacturing Managers new to medical devices or process validation
  • Medical device consultants new to process validation
$250
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty's training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
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