Qualification of contract manufacturer organizations based on practical experience

  • Speaker:Edwin Waldbusser
  • Duration:60Min
  • Product Code:GRC-90294

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Why should you attend:

Regulatory agencies require that companies carefully select suppliers and contract manufacturers? The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMO

Description of the topic:

CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements and the author’s personal experience in qualifying over 40 CMO’s in the medical device industry. We will cover in detail

Areas Covered in the Session:

  • CMO management principles
  • Supplier quality categories
  • Approved Vendor List (AVL)
  • Phases of CMO selection from initial telephone inquiry to quality survey to qualification audit
  • Planning a qualification audit-establishing evaluation team
  • Conducting a qualification audit-key points to evaluate
  • Decision factors for selecting a CMO-key practical points
  • Distinctive technical competence
  • Optimum CMO size
  • Risk of educating future competitor
  • Key points for the contract
  • Change approval by both CMO and company
  • Quality Agreement
  • Dealing with uncooperative suppliers 

Handouts: 

  • 6 page Pre-Audit Quality Survey form.
  • 25 page CMO audit form

Who will benefit:

  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Software developers
  • Engineering management
  • Regulatory personnel
  • Medical Device Industries

Instructor:

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting internationally in the areas of design control, risk analysis and software validation for the past 9 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$289

CD-DVD: Shipped within 2 working days

$409

USB - Shipped within 2 working days

$429

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,659

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,689

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