An intensive one or two day training course on how to establish and improve compliance with the Quality System (QS) Regulation which contains the GMP requirements for medical devices.
Background
The FDA Quality System Regulation 21 CFR Part 820 was published on Monday October 7th, 1996, and came into effect on June 1st, 1997, while the Design Control requirements came into full effect on June 1st, 1998.
FDA has stated that this major revision was necessary to improve medical device safety and effectiveness. In effect, it imposed significant new requirements on device manufacturers. In many cases manufacturers have not satisfactorily established compliance with the regulation and have received adverse FDA inspections, Warning Letters and Import Alerts.
Subsequently, FDA has published several significant guidelines on how the requirements contained in the QS Regulation may be satisfied, including those for design control, process validation and most recently combination products (21 CFR Part 4).
Learning Objectives
The course provides an excellent opportunity to:
- Obtain the most up-to-date information and interpretation on the Quality System Regulation, and how compliance with the regulation is determined by use of the Quality Systems Inspection Technique (QSIT).
- Improve confidence in preparing for, and hosting of an FDA inspection.
- Gain fresh quality improvement strategies for your company.
Course Details
The course presents the Quality System Regulation comprehensively, it uses case studies (2 on the 2 day course) and interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course.
Delegates receive a "Certificate of Attendance".