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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.
Does your current auditing program assure that you are efficiently meeting all FDA quality and regulatory requirements, such as labeling and premarket clearance? Is it Risk-based, as required by ISO 13485:2016. 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, thus reducing your risk of non-compliance. By using a risk-based approach to you auditing program, you can focus on those areas where you are most at risk, but still cover all your auditing requirements.
If you need to set up or improve your internal auditing system so that it adds value to your company, this webinar is for you!
Description of the topic:
This presentation will provide an understanding of the entire internal auditing process to efficiently meet the requirements and expectations of the FDA and ISO 13485 Notified Body auditors. Internal audits often get put off or just run through the same old thing every year. But a good auditing program can add value to the company. A well-planned audit program conducted by independent trained auditors will find problems before regulatory auditors do, and also before they become costly mistakes for the company.
This webinar will cover how to plan the audit system and how to plan a realistic annual internal audit schedule that covers all the requirements of your company’s quality system. This webinar will provide the information you need to know to:
· Develop or update and 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
Areas Covered in the Session:
This webinar will provide the information you need to know to:
Who will benefit:
· Audit Manager
· Internal auditor
· Supplier Auditor
· Quality Manager
· Regulatory compliance manager
· Supplier auditors
· Quality engineer
· Quality Consultant
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.