Engaged. Knowledge. Application
Supplier Quality Agreements CONTENT Package
Over 40 Pages including an article, SOP, Template, PowerPoint Presentation, and a DVD Interview
➢ 1. Quality Agreements Regulatory Considerations for Development and Implementation (Article)
➢ 2. Quality Agreements (SOP Template)
Click here to view complimentary excerpt
➢ 3. API Product Quality Agreements (Template)
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➢ 4. Quality Agreements Regulatory Considerations for Development and Implementation (PowerPoint Training Presentation)
Click here to view complimentary excerpt
➢ 5. Supplier Quality Agreements: What You Need to Know (DVD Interview - click here to see video clip)
1. Quality Agreements Regulatory Considerations for Development and Implementation (Article)
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This article discusses a number of critical issues related to executing Quality Agreements. Subject matter content includes a discussion of the regulatory basis for Quality Agreements (GMP regulations; specifically CFR 211.22). It also reviews the elements of a Quality Agreement, including an outline for content (chart) of a Quality Agreement between a contracting company and a contractor. Finally, the article discusses the use of a Quality Agreement during audits and inspections, as well as negotiating and legal review.
2. Quality Agreements (SOP Template)
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Can be used as reference for either benchmarking or auditing purposes.
3. API Product Quality Agreements (Template)
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The purpose of this document is to establish a Quality Agreement between Contracting Company Name and Contract Manufacturing Organization (CMO) Company Name regarding the manufacturing and supply of Drug Name Active Pharmaceutical Ingredient (API). This agreement outlines the responsibilities of Contracting Company Name and CMO Company with respect to the quality of the above drug substance, and the interface between the companies.
4. Quality Agreements Regulatory Considerations for Development and Implementation (PowerPoint Training Presentation)
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A readymade training presentation. Content is based on the article description above.
5. Supplier Quality Agreements: What You Need to Know (DVD Interview - click here to see video clip)
In this one on one interview, John Daley, VP Quality Distribution and Supply Chain, Boston Scientific, addresses a number of issues a number of topics related to effective managing Supplier Quality Agreements. The topics include, but are not limited to the following:
➢Roles and Responsibilities-Sponsor and Contractor
➢Auditing
➢Consultants
➢Length of Time
➢Version Control
➢Templates and Checklists
➢Contractors Drafting Quality Agreements
➢Specifications
➢Training
➢Working with Smaller Suppliers
*DVD to be shipped separately.
Supplier Quality Agreements CONTENT Package is only $99.00
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