This course covers insight knowledge in Pharmaceutical Quality Assurance 

Course Duration: 30 Classes   

Duration of Each Class: 2hours

Total Duration: 60hours

This Quality Assurance online Training Covers Development Quality assurance(DQA) ,In Process Quality Assurance(IPQA),Analytical Quality Assurance(AQA), Corporate Quality Assurance(CQA) ,Document Quality Assurance(DQA)

We Majorly focus on Process Validation, Cleaning Validation, Change Controls, Deviations, investigations, and Equipment Qualifications, Annual product Quality Review(APQR), whereas in Development Quality assurance we conduct class on Generic Product development, Vendor  Qualifications and Excipient Compatibility studies, Process development for Generic product, process optimization for generic product, Regulatory submissions and QbD accordingly ICH Q8, Q9,Q10, Review of MFC,MPC,PDR,BMR document, Method development, Method validation accordingly ICH Q2,method transfer, monitor of  Stability studies accordingly ICH Q2, and determine shelf life, retest period, expire date of the product, Whereas in Analytical QA(AQA) we covers very important topics like review of all documents, majorly focus on Data integrity in that we cover ALCOA, Audit trails checking,21 CFR part 11,Types of Inspections,review of 483 and warning letters,FDA inspections,OOS,OOT investigation,Incidents  investigations,CAPA writings,Stability Studies as per ICH Q1, Types of Pharma,overall view about regulatory guidelines like USP , BP,IP,EP,ICH, and Regulatory bodies like USFDA,MHRA,TGA, EMA, CDSCO,PMDA,Health Canada,PMDA,ANVISA

More information Contact: +91 9949596900

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