ComplianceOnline

'Bottom-Up' Quality System Implementation

Instructor: James Dunning
Product ID: 700671
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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This presentation will introduce an alternate, more effective approach.

Description

Why the bottom-up approach to quality system implementation is a better method for creating or significantly revising the quality systems relied upon by regulated companies.

The status quo for regulated companies creating or significantly changing their quality system documentation is to start from the top down, that is by creating or revising key top level documentation such as the Quality Manual or a series of company policies. Then the lower level supporting documents are created or revised to be aligned with the top-level requirements. This works, of course, but it is not efficient, and it substantial time passes before the changes are felt by the employees directly adding value to the product development and/or manufacturing processes. This presentation will introduce an alternate, more effective approach.


The following points will be highlighted:
  • Ways to identify where to start
  • How to manage quality system development process
  • How to get employees involved from the beginning
  • Why the bottom-up approach to quality system implementation is a better method for creating or significantly revising the quality systems relied upon by regulated companies.
Areas Covered in the seminar:
  • The problem with the status quo top down approach.
  • Why the bottom-up approach is a better method.
  • How to start a bottom-up quality system initiative.
  • How to manage a bottom-up quality system initiative.
  • Why employees, supervisors, managers, directors and executives will benefit.

Who Will Benefit:
This webinar will provide valuable assistance to regulated companies that need to establish their initial quality system or significantly modify their existing quality system. The employees who will benefit include:
  • Supervisors and Managers
  • Engineers
  • Quality Assurance Specialist
  • Quality System Auditors
  • Executive Management

Instructor Profile:
James Dunning, RAC (US), is founder and President of QualPro Consulting, LLC, a consulting firm that specializes in quality system development and regulatory compliance for companies that develop and manufacturer medical devices, and over-the-counter and prescription pharmaceuticals. QualPro Consulting, LLC also provides consulting services to food and food supplement manufacturers, contract manufacturers and contract laboratories.

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