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Process Validation - Overview of Why and How

Wednesday June 20 2018  10:00 AM PDT | 01:00 PM EDT

Training Duration = 60 Min                    Sponsored by Compliance Online

Click Here to register $349.00

Click Here to register and receive recording $199.00

This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.

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.

Learning Objectives:

  • 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

Areas Covered

  • What is process validation
  • Why is process validation necessary
  • Process validation guidelines
  • How to determine if a process requires validation
  • What processes should be validated
  • Process validation outline
  • IQ – Installation Qualification
  • OQ – Operational Qualification
  • PQ – Performance Qualification
  • Process monitoring

Instructor

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 compliance with 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 where she worked, 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 Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.