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:
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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. Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP.