FDA Quality System Inspection Technique (QSIT)
Date : 2 - 3 November 2016
Time : 9am - 5pm
Venue : E&O Hotel Penang
Enjoy Early Bird Course Fees when you register by 1 October 2016.
Early Bird (AMMI Members) - RM1,200 per pax
Early Bird (Non Members/ Public ) - RM1,400 per pax
NORMAL COURSE FEES
AMMI Members - RM1,400 per pax
Non Members/ Public - RM1,600 per pax
Note : Price stated is not inclusive of 6% GST
DURATION : Two (2) full days
US FDA regulated establishments manufacturing non-GMP exempt devices must establish and maintain a quality system appropriate to the specific medical device being manufactured and comply with the requirements of the US FDA’s Quality System Regulation (21 CFR 820 QSR). QSIT (Quality System Inspectional Techniques) is intended to increase manufacturer compliance, inspectional consistency, product quality, and the efficiency of the enforcement action review process.
This course will review the guidelines for the preparation and management of quality system inspections conducted by the FDA. Understand exactly what FDA investigators will look for during establishment inspections that focus on the specific subsystems of management controls; design controls; production and process controls (P&PC); and corrective and preventive actions (CAPA). Students will learn how to apply these principles to plan effective internal audits of medical device manufacturing firms.
This course empowers staff to identify any gaps that threaten the effectiveness of your Medical Device management systems. Auditors gain self-confidence through hands-on experience.