ComplianceOnline

Process Validation - Overview of Why and How

Instructor: Betty Lane
Product ID: 703520
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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 in the Webinar:

  • 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

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

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 for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct 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 RAPS, 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.

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