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5-Hour Virtual Seminar: Qualification & Control of Suppliers & Contractors for Pharmaceutical & Medical Device (30 August 2018 08:00 PDT) - ResearchAndMarkets.com

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The "5-hr
Virtual Seminar: Qualification and Control of Suppliers and Contractors
for Pharmaceutical and Medical Device"
webinar has been added
to ResearchAndMarkets.com's offering.

This training on qualification and control of suppliers and contractors
in the medical devices and pharmaceutical industry will review
compliance requirements, the qualification cycle, the key steps involved
in it, including the audit process, use of audit tools and evaluation to
decide on qualification/disqualification.

Learning Objectives

  • The Lack of Material Controls Causes Problems but Teamwork Overcomes It
  • The Component Specification & Associated Analytical Methods Is the
    Battleground
  • You Must Know More About the Supplier Quality System Than They-Be
    Prepared
  • Audit Tools helps To Guide the Qualification Decision
  • One of Your Roles is to Reduce Risk to Your Company
  • The Qualification Decision Will Never Be Forgotten
  • Follow-Up Activities Are More Important Than the Audit Report
  • Now, I Think I Understand What the FDA term, Supplier History, means

Agenda

11:00 - 11:10 Introduction & Overview

11:10 - 11:25 Quality 101

11:25 - 11:45 Compliance Requirements for Materials and Suppliers

11:45 - 12:00 The Dynamic Environment of Suppliers & Contractors

12:00 - 12:10 The Specification for the Component/Ingredient

12:10 - 12:20 The Role of Quality Control Laboratory

12:20 - 12:40 Laboratory & Material Qualification

12:40 - 12:50 Q&A 1

12:50 - 1:20 Break 1

1:20 - 1:30 Researching Suppliers and Contractors

1:30 - 1:40 The Questionnaire - An Under Rated Assessment Tool

1:40 - 1:50 The Audit Team

1:50 - 2:00 Planning the Audit

2:00 - 2:15 Conducting the Audit

2:15 - 2:25 Evaluating the Results and the Qualification Decision

2:25 - 2:35 Writing the Report and Presenting It to the Auditee

2:35 - 2:45 Q&A 2

2:45 - 3:15 Break 2

3:15 - 3:20 Material Validation

3:20 - 3:35 Corrective Action and Supplier Monitoring & Database

3:35 - 3:40 Supplier Quality Metrics

3:40 - 3:50 Summary

3:50 - 4:00 Final Q&A

For more information about this webinar visit https://www.researchandmarkets.com/research/ssczrm/5hour_virtual?w=4

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