FDA - The Quality System Regulation (QSR, 21 CFR Part 820) (2-day course)
Course summary
According to FOI data in 2001, 56% of foreign medical device manufacturers inspected by FDA, were issued with a Form 483. The current FDA Quality System Regulation, 21 CFR Part 820, including the Design Control requirements, came into full effect in June 1998. In many cases manufacturers have not satisfactorily established compliance with the regulation and have received adverse FDA inspections, including issuance of Warning Letters and Import Alerts.
Agenda
- FDA history, organization and foreign inspection history
- Overview of the QSR 21 CFR 820
- How to prepare for and manage an FDA inspection
- What happens after the inspection
- Software validation including requirements of 21 CFR 11, electronic data and signatures
- Process validation
- Complaint handling and medical device reporting 21 CFR 803 and 804
- Introduction to the QSIT
- QSIT requirements in relation to management responsibility
- QSIT requirements in relation to non-conformity and Corrective and Preventive Action (CAPA)
- QSIT requirements in relation to design control
- QSIT requirements in relation to production and process controls
- Good manufacturing or good management practice?
- Test (optional)
Objectives
This medical devices training course will enable you to obtain the most up-todate information available on the Quality System Regulation and how compliance with the regulation is determined through the use of the Quality Systems Inspection Technique (QSIT.) Delegates will obtain a good working knowledge of all aspects of the Quality System Regulation, and how this relates to the EU’s Medical Devices Directive. They will be able to prepare for, and host an FDA inspection with confidence and learn new quality improvement strategies and techniques.
Pre-requisites
Delegates will be expected to have educational levels appropriate to the functions listed below. Some familiarity with the FDA Quality System Regulation, 21 CFR Part 820 and EN ISO13485: 2003 would be an advantage but is not a requirement.
Who should attend?
- Quality assurance personnel
- Company personnel who are responsible and perform any regulated function including design, manufacturing, training, purchasing, etc. and who may be required to answer questions from FDA Investigators
- Regulatory affairs professionals
- Operators of a CAPA system
- Those involved in the review and oversight of the CAPA system
This medical devices training course is non-residential.
Further information
Fee: £820 + VAT
