Finding the Right Vendors for the Most Critical Supplies Management Report


WCG FDAnews

WCG FDAnews

Risk-Based Supplier Qualification:

Finding the Right Vendors for the Most Critical Supplies

FDAnews Management Report

https://www.fdanews.com/products/category/224-drug-books/product/61484

Bringing a compliant and quality pharmaceutical product to market leaves no room for inadequate or inconsistent supplier assessments.

How can one ensure that suppliers and contractors — who are often spread across the globe — are limiting risk and in compliance with relevant standards?

In the Risk-Based Supplier Qualification management report, international quality management expert Christian Gausepohl discusses the life cycle of a supplier relationship, how to determine excipient risks and ways to develop a supplier quality agreement. He shares advice on identifying manufacturing risks and includes key considerations for evaluating suppliers, auditing third parties and mitigating inherent risks.

This report will cover:

● Key considerations in evaluating suppliers

         a. Understanding the source and complexity of the supply chain

         b. The risk analysis needed for evaluating supply errors

         c. Estimating the probability of risks and their likely discoverability

         d. The difference between intermediaries and manufacturers

● Stages of risk assessment

         a. The life cycle of a supplier relationship

         b. How and when to conduct periodic supplier reviews

● Regulatory requirements for controlling suppliers

         a. Determining when to conduct a third-party audit

         b. Rules for importing starting materials

● Special considerations for evaluation

         a. Evaluating active pharmaceutical ingredient (API) and excipient

            suppliers

         b. Deciding how to handle atypical APIs

● Developing a supplier quality agreement

Not only does this report cover tips on creating an effective plan for addressing supplier risks, it also contains a 20-page risk-analysis worksheet on evaluating the impact and severity of supply errors. These tools and insights will give one everything needed to successfully bring a product to market.

Don’t miss this chance to learn from an industry expert and develop a plan for assessing and managing supplier risk.

Management Report Details:

Risk-Based Supplier Qualification:

Finding the Right Vendors for the Most Critical Supplies

FDAnews Management Report

https://www.fdanews.com/products/category/224-drug-books/product/61484

Price:

$397

Easy Ways to Register:

Online: https://www.fdanews.com/products/category/224-drug-books/product/61484

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

Share article on social media or email:

Leave a Reply