The seminar discusses Fundamental requirements as well as Advanced Subjects and Hot topics as below:

Fundamental requirements

Regulatory Affairs in connection with FMD (Falsified Medicines Directive) 

Facility Design 

Qualification, including leveraging and the family approach. 

Computerised systems 

Process Validation Life Cycle approach 

Cleaning Validation 

Technical Transfer 

Quality Control including data integrity. 

APIs Manufacturing Inspection/ Suppli-ers Auditing 


Advanced Subjects and Hot topics 

Regulatory updates. 

Contamination Control Strategy 

Dedicated Facilities / Toxicological Tool/ Cross contamination prevention 

Supply Chain Integrity 

Manufacture of Sterile Products 

Leechables and Extractables 

Root Cause Analysis 

Knowledge Management 

QRM and Inspectors’ Expectations