01
Session 1
Understanding the Self Inspection
02
Session 2
Planning and Scheduling Self Inspections
03
Session 3
Self Inspection Preparation
04
Session 4
Performing a Self Inspection
05
Session 5
Reporting and Documentation of Self Inspections
06
Session 6
Implementing Corrective Actions
07
Session 7
Continuous Improvement and Follow-up Inspections
08
Session 8
Why Audits are carried out?
09
Session 9
Types of Audits
10
Session 10
Hosting Regulatory Inspections
11
Session 11
Attributes and Experiences of a Good Auditor
12
Session 12
Post Audit Activities and Follow up
13
Session 13
PIC/S GMP Guide
14
Session 14
Critical Areas Often Overlooked in Audits
Our Courses
- Introduction to GMDP Regulations and Importance of GMDP
- Pharmaceutical Quality System (PQS)
- Personnel
- Premises and Equipments
- Documentation
- Production
- Quality Control
- Outsource Activities
- Complaints, Quality Defects, and Product Recalls
- Self-Inspection and Audit
- Good Distribution Practice (cGDP)
- Regulatory Affairs & Regulatory Submissions
