QS Regulation 4: Document and Purchasing Controls

<p>The fourth in a series of Quality System Regulation (QS Regulation) courses, this course focuses on the document controls requirements of 21 CFR Part 820, Subpart D and the purchasing controls requirements of 21 CFR Part 820, Subpart E. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Topics in this course include: Key Terms, Document Control, Evaluation &amp; Selection, Records &amp; Data, and Preamble. After completing this course, learners will be able to recognize the document and purchasing controls requirements of the QS Regulation. </p><p><span>Learners should complete <em>QS Regulation 1: Overview and General Provisions, QS Regulation 2: Quality System Requirements,</em> and <em>QS Regulation 3: Design Controls</em> before taking this course.</span></p>

After this course learners will be able to recognize the document and purchasing controls requirements of the qs regulation. recognize document and purchasing control procedures that manufacturers must establish and maintain. identify key definitions relating to these requirements. recognize some of the comments and responses that relate to document and purchasing controls in the preamble to the regulation.