Pharmaceutical Auditing


1.0 Audit System

               1.1 System requirements

2.0 Responsibility for Conducting Audits and Types of Audits

2.1 Global quality assurance audits

2.2 Site quality audits

2.3 For cause audit

2.4 Due diligence assessment

2.5 Global computer systems

3.0 Audit Program

3.1 Training and qualification

3.2 Audit program

4.0 Audit Process

4.1 Audit plan

4.2 Audit preparation

4.3 Audit execution

4.4 Audit observation report

4.5 Classification

4.6 Audit responses

4.7 Final audit report

4.8 Notification to Qualified Person

4.9 Tracking of actions

4.10 Trend analysis

5.0 Self-Inspections

6.0 Document Retention 


Duration
3 days
Language
English
Participants
8 - 15
Fees