ISO 13485 and Regulatory Affairs Training

Duration: 90 Minutes
The Webinar will extensively cover comparison of various QMS Objectives, Objective of ISO 13485:2003, how to set out requirements for a QMS that is capable of consistently meeting customer requirements, including regulatory requirements. The speaker will also speak about the objectives of ISO 9001:2008 and how to set our requirements for a voluntary, generic QMS that is capable of meetings customer & Regulatory requirements, and enhancing customer satisfaction through processes including continual improvement. The webinar will also enhance your knowledge on objective of the FDA Quality System Regulation and how to set our requirements for a QMS that is capable of consistently providing safe and effective medical devices.
ISO 13485 Training
Instructor: Dennis L. Gorectke
Product ID: 500423

Why Should you Attend:
To learn more about medical devices and FDA requirements and to improve and implement quality systems within the company to perk up business.

Objectives of the Presentation:
The objectives of the webinar are
  • Management Review
  • Document Control
  • Internal Audit
  • Control of Nonconformance
  • Corrective & Preventive Action
Who can Benefit:
  • Quality and Regulatory affairs Managers
  • Anyone in the quality improvement section in Medical device.
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
Get life time access with download option!
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  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
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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:
Dennis L. Gorectke has an entrepreneurial spirit having Run ISO Documents & Six-Sigma Consultants very successfully since 1992. He did ISO 9001 Training for the SBDC and UW Whitewater for five Years. He has worked for the Corporate Headquarters Quality Departments of Harley-Davidson Company, Johnson Controls and the Ford Fairlane Training & Development Center in Dearborn Michigan. All these Positions were as a Consultant & Trainer.

In addition he's worked for the Sci-Med Division of Boston Scientific, and Zimmer Spine in Minneapolis, MN; plus the Ethicon Division of Johnson & Johnson in Somerville NJ, Supplier Contract in Christchurch, UK, and Pro QC International, Integra Life Sciences all doing ISO 13485 Audits of their Supplier base.

In addition he has Audited Companies in Canada and New York on Behalf of Subaru for TS-16049 Dennis L. Gorectke also completed 10 Successful Projects to attain MR Lean Six-Sigma master Black Belt.


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