How Create a Value-added cGMP/ISO 13485 Internal/Supplier Auditing System

Why Should You Attend:

Does your current auditing program assure that you are efficiently 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 seminar 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.

This webinar will cover how to create an auditing system including how to plan a realistic annual audit schedule that covers all the requirements of your company’s quality system and any suppliers that you need to audit. 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 seminar will explain how these are incorporated into your audit program without adding a lot of additional audits.

Learning Objectives:

This webinar will provide valuable assistance in:

• Understanding the value of internal and supplier audits to your company
• Understanding Internal vs. external audits
• Streamlining Your Audit Process
• Auditor Training
• Audit Planning
• The Audit Process
• Follow-up and Closure
• Understanding what you need and do not need to show the FDA about your internal audits

Areas Covered in the Webinar:

This webinar will provide the information you need to know to:

• Develop or streamline an auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485:2016
• Manage an Audit program
• Understand the difference between internal and external audits
• Learn how the auditing system can add value to your quality system and your company
• Understand what makes a good audit
• Understand the skill required for an auditor
• Understand what the FDA must see to verify that you are conducting your internal and supplier audits as required

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Audit Managers
• Prospective Audit managers
• Current Internal auditors
• Prospective Internal auditors
• Current and prospective supplier auditors
• Quality Management
• Regulatory compliance managers
• Quality engineers

Betty Lane
Founder and President, Be Quality Associates LLC

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 for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

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 as an Adjunct 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 (RPI), and an MBA from Northeastern University.

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