Guidance on Quality Agreements for FDA Regulated Industries
Duration : 75 Minutes
Joy L. McElroy,
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, the FDA issued dozens of 483 observations relating to topics governed by the quality agreement system. Furthermore, in November 2016, the FDA finalized the "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry" document.
Due to this new guidance, you can be sure that your firm's quality agreement will receive increased scrutiny, leaving you vulnerable to the risk of non-compliant GMP products and services if your agreements aren't clear and enforced.
Course Objectives:
• Identify FDA regulations and new guidance regarding quality agreements
• Utilize tips to help you manage quality agreements effectively
• Review the pitfalls to avoid when developing your program
• Organize stakeholders, develop a comprehensive document, and initiate
• Implement oversight steps that keep you compliant and on track towards continuous improvement
Why Should You Attend:
In this session, industry expert Joy McElroy will provide a fundamental overview of what an effective quality agreement program looks like and how to manage it. Joy will guide you through a quality agreement framework that may fit into your organization's vendor/supplier qualification program. This webinar will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective. Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration.
Course Outline:
• Regulatory requirements for supplier qualification
• Responsibilities of manufactures and suppliers
• The who and what of a good Quality Agreement
• What a Quality Agreement is - and is not
• What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
• Responsibilities of the owner vs. contract facility
• GMP responsibilities
• Best practices for a good quality agreement
• A comparison of the new guidelines from the FDA and the EU
• Documentation requirements and audit trails
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance
• External Manufacturing / Outsourcing
• Quality Auditing
• Technology Transfer
• Regulatory Affairs / Compliance
• Supply Chain
• Purchasing
• Risk Management
• Managers and QA personnel from Contract Manufacturing Organizations (CMOs)
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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