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FDA's Expectations from Supplier Management for GMP: Quality Agreements and More.

Compliance Key INC - FDA Compliance Training
Danielle DeLucy, MS, is Keynote speaker at Compliance Key, Inc. She is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.

  Webinar Id:  LSHCDD007 
 10:00 AM PT | 01:00 PM ET 
 03/19/2018
 Duration: 60 mins 
Overview
When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier's acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your expectations. This is a first step in selecting the correct supplier to meet your outsourcing needs.
Why should you attend this webinar?
Many organizations conduct supplier audits because they are required to do so by their customers or a regulatory agency. Others conduct the audits because they have been led to believe that it's a good tool for comparing various suppliers against an arbitrary list of criteria. While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming product consistently, reliably and on-time. It should be one of the most important
initiatives toward fulfilling the goal of having a sustainable supply chain.
Areas Covered in the Session:
  • Why audit your supplier?
  • Who will audit your supplier?
  • When will you audit your supplier?
  • What will you audit?
  • How will you conduct the audit?
  • How to prepare a pre-audit questionnaire.
  • Areas to be audited and using check lists.
  • How to conduct effective close out meetings.
  • The advantages and disadvantages of using numerical audit scores.
  • Issuing observation reports and recommendations to your management and to your potential suppliers.
Who can Benefit:
  • QA staff and management
  • Supply Chain representatives
  • Regulatory Affairs staff and management
  • Compliance auditors

Compliance Key INC
717-208-8666

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