- Develop or update a risk-based internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
- Manage an Internal Audit system
- Understand the difference between internal and external audits
- Learn how the internal auditing system can add value to your quality system and your company
- Understand what makes a good internal audit
- Understand the skill required for an internal auditor
- Understand what the FDA must see to verify that you are conducting your internal audits as required
Internal audits are required by both the FDA and ISO 13485. This seminar will cover how to create a Risk-based, value-added internal auditing system for compliance to FDA and ISO 13485 internal auditing requirements, including ISO 13485:2016. It will include how to set up and manage the auditing system, how to plan a realistic annual internal audit schedule that covers all the requirements of your company’s quality system, as well as an overview of how to conduct an internal audit, and document the results. This webinar will explain how the principles of risk can be incorporated into your audit program without adding a lot of additional audits, thus reducing your risk of non-compliance. It will discuss the value of a good internal auditing program in reducing compliance risk of all types.
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.
With a FREE membership you can get one Exclusive Video every 30 days!
With a free memebrship account, you can browse the entire library, buy credits & attend live webinars and read expert posts. Join and explore the coolest complaince platform ever. Feel free to upgrade anytime to view all Exclusive content and get additional benefits for your account.
Do I have to pay to join?
For FREE signups there is no payment required. No Credit Card needed. We also offer EDGE & PRO, paid memberships.
What are the different formats?
There are Live and Recorded, Expert led webinars. Durations vary from 30min to 6hrs. Standards & checklists are in pdf form
What if I am interested in more than one exclusive?
You can upgrade to EDGE memebrship at any time and enjoy unlimited Exclusive viewing. All our memebrships are annual plans.
How many videos can I watch?
As a FREE memebr you get 1 free exclusive video every 30days. You can buy additional videos.
Who are the Experts?
All Experts on our platform are handpicked or referred by other Experts based on years of experience & proven expertise in providing learning & consulting advice.
What if I have questions after watching a video?
We provide first of its kind, Expert on Call service, where you can directly schedule one on one call with the Expert of your choice & discuss.