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Who should attend Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries
This webinar will provide valuable assistance to all personnel in: Quality Assurance, External Manufacturing / Outsourcing, Quality AuditingTechnology Transfer, Regulatory Affairs / Compliance, Supply Chain, Purchasing, Risk Management, Managers and QA personnel from Contract Manufacturing Organizations (CMOs)
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Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries  

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This webinar will provide valuable assistance to all personnel in: Quality Assurance, External Manufacturing / Outsourcing, Quality AuditingTechnology Transfer, Regulatory Affairs / Compliance, Supply Chain, Purchasing, Risk Management, Managers and QA personnel from Contract Manufacturing Organizations (CMOs)

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Seminar Summary:

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  (see full course description)

 
 

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Training Course Syllabus:


Objectives of the Presentation

After attending the 75 minute webinar, you will be able to:
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.

Areas Covered

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

Seminar Summary:

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  (see full course description)

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