How Create a Value-Added cGMP & ISO 13485 Internal Auditing System

Duration: 60 Minutes
Internal audits are required by both the FDA and ISO 13485. This webinar will cover creating of a Risk-based an internal auditing program for compliance to FDA and ISO 13485 internal auditing requirements.
cGMP and ISO 13485 Internal Audit System
Instructor: Betty Lane
Product ID: 500328

It will include how to set up and manage the auditing system, as well as an overview of how to conduct an internal audit, and document the results. It will discuss the value of a good internal auditing program in reducing compliance risk of all types.

This seminar will cover how to create a Risk-based, 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. This seminar will explain how the principles of risk are incorporated into your audit program without adding a lot of additional audits, thus reducing your risk of non-compliance.

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

Objectives of the Presentation:
  • Learn How to develop or streamline and internal auditing system based on the principles of risk management but is still compliant to FDA cGMP/ Quality System Regulation and ISO 13485
  • Know the difference between internal and external audits
  • Understand what skills are required for an internal auditor
  • Learn how the internal auditing system can add value to your quality system and your company
  • Understand what the FDA must see to verify that you are conducting your internal audits as required
Who can Benefit:
  • Audit Managers
  • Prospective Audit Managers
  • Current Internal Auditors
  • Prospective Internal Auditors
  • Quality Management
  • Regulatory Compliance Managers
  • Supplier Auditors
  • Quality Engineering
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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  $500.00 Training CD
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Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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. Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs 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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