Supplier Qualification in the Pharmaceutical Supply Chain

Duration: 120 Minutes
The importance of supplier qualification in the pharmaceutical supply chain continues to be a growing concern for global regulatory authorities. Over the past decade, there have been many instances of quality and compliance failures that have negatively impacted public health due to the lack of assurance that materials utilized in the manufacturing processes were produced under strict current Good Manufacturing Practices (cGMPs).
Supplier Qualification
Instructor: Angela K. Dunston
Product ID: 501351
Primary manufacturing organizations must ensure that systems and processes are in place to ensure that suppliers are appropriately managed through the entire lifecycle of the product. Pharmaceutical organizations that understand the importance of the supplier qualification process and implement a model that addresses the aggregate need of buyer, suppler, and customer will position themselves for success in the highly competitive global marketplace.

Objectives of the Presentation
  • Learn how to determine raw material criticality classifications
  • Quality system requirements to identify, select, approve and qualify suppliers
  • Identify basic requirements for the approval of materials
  • Why evaluation of distribution and supply need to be included in the supplier qualification process
  • Evaluation process for critical vs. non-critical materials
  • Learn why changes should be evaluated prior to being implemented
  • Vendor management across the life cycle
Why Should you Attend
Manufacturers of medicinal products, APIs and registered intermediates for APIs are responsible for approving and qualifying their suppliers and to monitor on an ongoing basis the performance of their critical suppliers. Supplier Qualification/Management programs will be evaluated by Regulatory Agencies during the inspection process with that expectation that pharmaceutical organizations periodically audit their API supplier / manufacturer.

Areas Covered
  • Introduction
  • Background
  • Supplier selection process
  • Due diligence process
  • Quality assessment of all suppliers
  • Management evaluation
  • Change control and production assessment
  • Supply chain security
  • On-going monitoring and evaluation
  • Conclusion/summary
Who can Benefit
  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Quality Project Managers
  • Auditing Professionals
  • Microbiology Professionals
  • Purchasing
  • Supplier Chain Management Professionals
Topic Background
Introduction of raw materials and components into a manufacturing process can have a detrimental impact of the quality of the final product. It is important to qualify suppliers prior to use of the material or component to minimize the potential impact to the public. An efficient risk-based Supplier Qualification Program is critical to ensure the safety, purity, efficacy, and quality of a product and meet global regulatory requirements.
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Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
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