Since 2001 the FDA has used a system based technique for the inspection of drug and biological production facilities. Although the Quality unit and the Quality System are always a part of the inspection, the system based technique focuses on the responsibilities of other units within the organization. This discussion focuses on the responsibilities of the laboratory within the systems based inspection concept and discusses:
- What constitutes the Laboratory Control System.
- The responsibilities of the Quality Control Laboratory.
- Responsibilities of the Quality unit.
- FDA 483 citations that have resulted from deficiencies in the Quality Control Laboratory and an analysis of the cause.
- The impact of the systems concept on the organization.
Areas Covered in the Seminar:
- What is a Systems Based Inspection.
- Why FDA moved to Systems Based Inspections.
- What is different from the old inspectional techniques.
- What is the Laboratory Control System.
- Has the new technique changes the findings?
- What are the responsibilities of the various units in the organization.
- What are the specific things the FDA is looking at.
- What other changes can be anticipated in FDA inspections.
Who will Benefit:
This webinar will help the personnel in the quality control laboratory understand their role in the new FDA focus on Systems. It will also help Quality personnel understand their role in all aspects of the Systems Based Inspections. The following individuals will benefit
- Personnel who have responsibilities in laboratory operations, including Directors, managers and line personnel.
- QA directors, managers and those involved with Change Control, deviation investigations and Training.
- Personnel in analytical development developing new methods.
- Validation specialists.
- Personnel involved with the testing of all dosage forms.