Source: http://www.ulqcl.com/old-microsite-intances/advamed-approved-online-learning/available-courses/quality-systems-regulation-qsr/
Timestamp: 2013-05-24 13:43:43
Document Index: 263144466

Matched Legal Cases: ['art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820']

Quality Systems Regulation (QSR)	UL Quality, Compliance and Learning
Quality Systems Regulation (QSR)Inspection & EnforcementClinicalGood Manufacturing Practices (GMP)Quality Systems Regulation (QSR)Health Care Compliance (HCC) Quality Systems Regulation (QSR)QS Regulation 1: Overview and General Provisions
This course introduces the Quality System (QS) Regulation (21 CFR Part 820)--a framework of basic requirements for manufacturers of finished medical devices. The course covers the history of the regulation, as well as its requirements, scope, and key terms. The course also discusses the manufacturer’s responsibility for a quality system under this regulation.
The second in a series of Quality System Regulation courses, this course focuses on the management responsibility, quality auditing, and personnel requirements of 21 CFR Part 820, Subpart B. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Learners should complete QS Regulation 1: Overview and General Provisions before taking this course.
The third in a series of Quality System Regulation courses, this course addresses design controls requirements of the Quality System Regulation. Learners should complete QS Regulation 1: Overview and General Provisions and QS Regulation 2: Quality System Requirements before taking this course. QS Regulation 4: Document and Purchasing Controls
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. Learners should complete QS Regulation 1: Overview and General Provisions, QS Regulation 2: Quality System Requirements, and QS Regulation 3: Design Controls before taking this course.
QS Regulation 5: Identification & Traceability; Production & Process Controls
The fifth in a series of Quality System (QS) Regulation courses, this course focuses on Identification and Traceability (21 CFR Part 820, Subpart F) and Production and Process Controls (21 CFR Part 820 Subpart G). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.
The purpose of the Production and Process Controls requirements of the QS Regulation (21 CFR 820.70, 21 CFR 820.72, 21 CFR 820.75) is to ensure that manufacturers produce devices that conform to their specifications. Where any deviations from specifications could occur during manufacturing, process control procedures must describe the controls necessary to ensure the devices will conform to their specifications. Process control procedures also help to ensure consistency in manufacturing.
After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the Identification and Traceability, and Production and Process Controls requirements of the QS Regulation.Learners should complete the previous courses in the series before taking this course.
The sixth in a series of Quality System (QS) Regulation courses, this course focuses on Acceptance Activities (21 CFR Part 820 Subpart H) and Nonconforming Product (21 CFR Part 820 Subpart I). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Learners should complete the previous courses in the series before taking this course.
The seventh in a series of Quality System (QS) Regulation courses, this course focuses on Corrective and Preventive Action (21 CFR Part 820 Subpart J). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. The intent of 21 CFR 820.100 is to correct or prevent poor practices, not simply to correct or prevent bad product. Correction and prevention of unacceptable quality system practices should result in fewer nonconformities related to product. Compliance with the corrective and preventive action requirements of the Quality System (QS) Regulation will allow a firm to monitor, identify, and react to existing product and quality system problems, as well as indicators of potential problems. These activities will help manufacturers identify opportunities to improve their products and quality system, as well as protect consumers by initiating field actions where necessary. After completing this course, you’ll be familiar with a manufacturer’s responsibilities relative to the corrective and preventive action requirements of the QS Regulation. Learners should complete the previous courses in the series before taking this course.
This course is the eighth in a series of Quality System (QS) Regulation courses. This course focuses on Labeling and Package Control (21 CFR Part 820 Subpart K) and Handling, Storage, Distribution, and Installation (21 CFR Part 820 Subpart L). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. The requirements of the QS Regulation relative to the Handling, Storage, Distribution, and Installation of medical devices are intended to help ensure that medical device mix-ups, damage, deterioration, contamination, or other adverse effects do not occur. After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the labeling, packaging control, handling, storage, distribution, and installation requirements of the QS Regulation.Learners should complete the previous courses in the series before taking this course.
Topics include:Key Terms Label Integrity Labeling Operations Handling/Storage Areas Control & Distribution Device Installation QS Regulation 9: Records
The ninth in a series of Quality System (QS) Regulation courses, this course focuses on Records (21 CFR Part 820 Subpart M). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. One of the basic themes of the Quality System Inspection Technique (used during inspections of medical device manufacturers) is the “Establish Test.” The QS Regulation requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically), and implement.” Records play a vital role in FDA’s ability to confirm that procedures have been appropriately implemented and, on a broader scope, that an adequate and effective quality system has been established and maintained by the firm being inspected. After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the records requirements of the QS Regulation.
Learners should complete the previous courses in the series before taking this course. Topics include:General Requirements Device Master Records Device History Records Quality System Records Complaint Records Investigations Complaint Unit QS Regulation 10: Servicing; Statistical Techniques
The tenth in a series of Quality System (QS) Regulation courses, this course focuses on Servicing (21 CFR Part 820 Subpart N) and Statistical Techniques (21 CFR Part 820 Subpart O). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.
Statistical techniques may be employed to fulfill a number of QS Regulation requirements. Where statistical techniques are used, manufacturers must establish procedures for identifying valid statistical techniques.
After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the servicing and statistical techniques requirements of the QS Regulation
Learners should complete the previous courses in the series before taking this course.
Topics include:Key Terms Servicing Requirements Analysis Statistical Techniques QS Regulation 11: Application and Inspection of QS Regulation Requirements
This is the eleventh and final course in the series of Quality System (QS) Regulation courses. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. This course focuses on the application and inspection of Quality System Regulation requirements within a medical device manufacturer’s quality system.During inspections, FDA will assess whether a manufacturer has established procedures and followed requirements that are appropriate to a given device under the current state-of-the-art manufacturing for the specific device.After completing this course, you will be familiar with the application and interrelationship of QS Regulation requirements within a medical device manufacturer’s quality system. You will also be familiar with the basic concepts of the Quality System Inspection Technique (QSIT), which is the inspection process currently used by the FDA to conduct Level 2 Baseline (Comprehensive) quality system inspectionsLearners should complete the previous courses in the series before taking this course.
Topics include:Key Terms Seven Subsystems Subsystems and QSIT For the entire course library with descriptions please download the UL and AdvaMed Course Guide.