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

Why Should You Attend:

Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.

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.

This webinar will provide attendees with the information and tools necessary to develop, implement, and effectively utilize and maintain a program for supplier quality management that will satisfy the FDA’s requirements without creating undue burdens for the organization.

Learning Objectives:

• Understanding the FDA’s requirements for medical device supplier assessment and approvals
• Learning “who” are considered to be suppliers
• Knowing how to structure a supplier quality agreement
• Selecting the potential methods for evaluating and assessing suppliers

Areas Covered in the Webinar:

• Regulatory requirements for supplier qualification
• Responsibilities of manufactures and suppliers
• Best practices for supplier selection, qualification and management
• What are the FDA’s expectations in regards to quality agreements?
• What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
• Best practices for a good quality agreement
• Supplier audits
• Documentation requirements and audit trails

Frequently Asked Questions:

1. Can you speak to the pros and cons of utilizing supplier questionnaires for the purpose of auditing versus on-site supplier audits and the associated risks?
2. What is the FDA position on the use of Joint Audits for supplier audits? Are Joint Audits deemed an acceptable practice for maintenance or re-qualification type audits (i.e. is the an acceptance resources)?
3. Do the CGMP regulations permit the destruction of an internal quality assurance audit report once the corrective action has been completed?
4. Can Cannabis be Imported into the EU without GMP Certification?
5. Have you see the audit score used in the calculation of the supplier score?
6. Although recommended, would early phase, ex. phase I, research investigational products made in labs/facilities receive a 483 if no supplier qualification is in place for these facilities?

Who Will Benefit:

• Quality Assurance/Quality Control Directors, Managers, and Specialists
• Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
• Purchasing/Materials Management Directors, Managers, and Specialists
• Engineering/Development Directors, Managers, and Specialists
• Document Control Managers and Specialists

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena while increasing her responsibility. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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