PHARMA

Deviation in Pharmaceutical Industry 
Types of Deviations in Pharmaceutical industry 
Deviation management in pharmaceutical industry (Deviation Handling) 
Example of Deviation 
Handling of unplanned deviation - SOP 
Importance(requirement) of deviation in pharmaceutical industry 
Definition of change control in Pharmaceutical industry- basic 
Classification of Change control 
Change control management in Pharma 
What is standard operating procedure in pharma  
Objective of preparation of standard operating procedure(SOP)
SOP format and templates in Pharma  
Types of SOP in pharmaceutical industry 
what is quality Audit in Pharma 
Types of Audit in Pharmaceutical industry 
Documentation for audit in pharma 
SOP on personnel hygiene in pharmaceutical industry
Role of QA in stability
Principle of Auditor  

Objectiveof APQR (Annual product quality review) in Pharma

 

 

QUALIFICATION & VALIDATION

Process Validation in Pharma - Definition and Types of Process Validation
What is validation in pharmaceutical industry: Basic and Importance 
Prospective Validation.- Types of process Validation
Continuous Process Validation and verification
Re validation - Types of Process Validation  
HVAC Validation parameters and test procedure 
Air Velocity Test Parameter and Procedure -HVAC Validation in Pharma  
Filter integrity/Filter Leak Test -HVAC Validation in Pharma 
Equipment Qualification in Pharma 
Factory Acceptance Test in Equipment Qualification 
Site Acceptance Test in Equipment Qualification
Design Qualification in Pharma 
Installation Qualification of equipment in Pharma
Operational Qualification of Equipment in Pharma

QUALITY CONTROL /MICROBIOLOGY

Difference between Assay and purity 
What is limit of detection (LOD)  
Why 70% alcohol is most effective as a disinfectant?
What is impurity and Classification of impurities in Pharmaceutical industry