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 risk properly, you may face enforcement actions such as fines or recalls. However, 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
Process validation is a requirement but knowing when to validate or revalidate a process is essential. If you do not validate risk properly, you may face enforcement actions such as fines or recalls. However, 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
Speakers
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.
