Quality System
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Who Should Attend
This intensive course has been designed to benefit those in
the Pharmaceutical industry with responsibilities related to the
Quality System being used by the FDA in its Drug cGMP
Inspections. The course is thus particularly suitable for
personnel working in:-
QA, QC
- Regulatory Affairs
- Pre-market Departments
- Initial NDA submissions
- Site and Corporate Management
Description
The FDA is using a systems approach for both its domestic
and foreign drug cGMP inspections. The approach consists
of classifying a firm’s operations into six types of systems: (1)
The Quality System (2) Facilities & Equipment System (3)
Materials System (4) Production System (5) Packaging &
Labeling System and (6) Laboratory Control System. The
systems inspected depend upon the purpose of the
inspection and the FDA’s prior experience with the firm but
always includes the Quality System for which compliance is
mandatory. Discussions will include the following subsystems:
Deviations, Stability Failure Handling, Change
Control, Product Release, Validation & Annual Product
Reviews, Rework & Reprocessing, Returned & Salvaged
Goods, Complaints, Personnel, Training as well as preventive
& product improvement activities. Responsibilities for these
sub-systems include QA in some type of role. QA also plays
a role in the other systems, and therefore, QA’s role in the
Facilities & Equipment, Materials, Production, and Packaging
& Labeling Systems will also be discussed in detail. The
Laboratory Control System has not been included because it
has been made the subject of a separate CfPA course. The
need for integrating the design, operation and responsibilities
for each of the systems and sub-systems will be emphasized
throughout. The course will be presented by a three person
team which includes an ex-FDA official who will provide an
FDA perspective.