This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
Why Should You Attend:
Does your current auditing program assure that you are meeting all FDA quality and regulatory requirements, such as labeling and premarket clearance?
Does it assure that you are meeting all European and Canadian requirements, if you sell products in those areas?
If not or if you do not know, this webinar will explain how these are incorporated into your audit program without adding a lot of additional audits.
This webinar will cover how to create a value-added internal auditing system including how to plan a realistic annual internal audit schedule that covers all the requirements of your company’s quality system.
Areas Covered in the Webinar:
Who Will Benefit:
Duration: 60 Minutes
Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version
Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version
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.