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.
Learning Objectives:
Understanding the value of internal audit to your company
Understanding internal vs. external audits
Streamlining your audit process
Auditor training
Audit planning
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:
Develop or streamline an internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
Manage an internal audit system
Difference between internal and external audits
How the internal auditing system can add value to your quality system and your company
What makes a good internal audit
Skill required for an internal auditor
What the FDA must see to verify that you are conducting your internal audits as required
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.
Learning Objectives:
Understanding the value of internal audit to your company
Understanding internal vs. external audits
Streamlining your audit process
Auditor training
Audit planning
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:
Develop or streamline an internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
Manage an internal audit system
Difference between internal and external audits
How the internal auditing system can add value to your quality system and your company
What makes a good internal audit
Skill required for an internal auditor
What the FDA must see to verify that you are conducting your internal audits as required
Speakers
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 as manager or director, 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 RAPS, 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, and an MBA from Northeastern University
