Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries
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.Learning ObjectivesIdentify FDA regulations and new guidance regarding quality agreementsUtilize tips to help you manage quality agreements effectivelyReview the pitfalls to avoid when developing your programOrganize stakeholders, develop a comprehensive document, and initiateImplement oversight steps that keep you compliant and on track towards continuous improvementAreas CoveredRegulatory requirements for supplier qualificationResponsibilities of manufacturers and suppliersThe who and what of a good Quality AgreementWhat a Quality Agreement is - and is notWhat is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?Responsibilities of the owner vs. contract facilityGMP responsibilitiesBest practices for a good quality agreementA comparison of the new guidelines from the FDA and the EUDocumentation requirements and audit trailsWho Should AttendQuality AssuranceExternal Manufacturing / OutsourcingQuality AuditingTechnology TransferRegulatory Affairs / ComplianceSupply ChainPurchasingRisk ManagementManagers and QA personnel from Contract Manufacturing Organizations (CMOs)Why Should You AttendIn 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.
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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.
Learning 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
Areas Covered
- Regulatory requirements for supplier qualification
- Responsibilities of manufacturers 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
Who Should Attend
- 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)
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.