SPENCER BROWN

Quality Agreement For Medical Devices

This 90-minute training helps you understand FDA QSR requirements, good business practices and the role of a supplier quality agreement. This webinar will help you implement an effective and FDA-compliant supplier management system. MEDICAL DEVICE GUIDANCE DOCUMENT, Medical device guidance document medical device, Guidance, Medical Device, Medical Device, MEDICAL DEVICES: Guidance document, DOCUMENT, Medical Device (SaMD): Application of Quality 8 Prepared by Ombu Enterprises, LLC.ISO 13485:2003 Medical Devices Quality Management Systems Regulatory Requirements Iso 14971:2007 Medical Devices Application of Medical Device Management , this agreement covers the products listed in the table below. Note: List the products the supplier makes available to the customer. The list should be specific, but should not contain revision levels or other information at that specific level. For example, it would be better to say feed number: A1234. instead of the feed number: A1234 Revision C. You probably don`t want to re-approve the vendor contract for each product review change. Products covered by this agreement Product Name Supplier Part number Part number of the site (s) the supplier produces the product in one of the sites listed below. I recommend that a supplier quality contract be put in place at the beginning of the development process. Maintaining quality in your supply chain at the beginning of the game certainly can`t hurt. If you start educating your suppliers and working productively with them at this point, avoid surprises later in the development cycle – if it may be too late to change a key component or supplier. In the eyes of the FDA, any activity that is not documented may as well not have occurred.

A quality agreement gives the contracting establishment and the owner the opportunity to define the expectations of those who verify and approve quality documents. Protocols should be described for changes to standard operating procedures (SOPS), manufacturing documents, specifications, validation documentation, and all other essential documents relating to products or services provided by the contracting body. The role of both parties in the development and maintenance of original documents or authentic copies compliant with the CGMP must be indicated. The agreement should also clarify how these recordings are easily made available for consultation. It is advantageous to include a statement indicating that electronic records are stored in accordance with CGMP and kept in a searchable condition during the required registration periods, in accordance with FDA requirements. Effective supplier management can help prevent problems and reduce their impact if they occur. With a greater focus on supplier management, you can expect strong coverage of this area during an FDA inspection. The FDA Quality System (QSR) Regulations explain how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. A common approach uses a supplier quality agreement. Cooperation is essential to any successful business partnership, which is why it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization.

Processes such as corrective and preventive measures (CAPA) and gap management can lead to dissent, so responsibilities related to investigations and other processes related to the management of quality events should be clearly defined in the agreement.

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REP   ACTING: VLA     VO: SUE TERRY VOICES    LIT: RICHARD SCRIVENER

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