Date: 8th - 15th July, 2008

Location: web seminar, USA

Summary:
Clinical, Cosmetic, Pharmaceutical, Water - Seminar

The objective of this course is to foster an understanding of the Quality Systems (QS) concept used by regulatory agencies and the characteristics of the subsystems involved, as well as enabling participants to develop a better understanding of the impact of the QS on Quality Assurance in their facility.

There will also be discussion on the "systems approach" used by Regulatory agencies for carrying out both domestic and foreign inspections. This approach consists of classifying a firm's operation into six types of systems, with the systems inspected depending upon the purpose of the inspection and the agencies prior experience with the firm, but always incorporating the Quality System for which compliance is mandatory. These systems will be reviewed in detail, including how to prepare for inspections.

This live and interactive and 3-session series will also cover the need for integration of design, operation and responsibilities when creating a quality system and sub-systems.

Points to be Covered:
Session 1 (July 8, 2008):
Current Situation
Quality Risk Management
Concept of modern Quality System
Review of Quality System models

Session 2 (July 9, 2008):
Six System inspection approach
FDA inspections
Inspection in six systems

Session 3 (July 15, 2008):
Why an FDA Inspection?
How to prepare for an FDA inspection
483 Citations
Reference and Workshop