Pharmaceutical Administration and Management, Handling laboratory and manufacturing deviations, Pre approval inspections, Impact of Total Quality performance, GMP Certification and enforcement actions, Maintenance and Update of Product Master Files , Internal Compliance of Documentation, Coordination and Assembling of CTD/eCTD, Quality systems, Quality Assurance, Method Validations, Process Validations, Master Validation Plan, Protocols, Standard Operating Procedures (SOPs), Auditing and Compliance Functions, Regulatory strategies, Regulatory agencies, legislation and documentation systems as required for USFDA, UKMCA/UKMHRA, MCC, WHO etc.

Pharmacovigilance

Graduate
The eligibility for the training program is graduation in any discipline. The program is most suitable for Doctors, medical professionals, pharmacists etc. Any one of the following minimum qualifications is mandatory to be eligible: B. Sc., / M. Sc., in Life science with minimum 50% in any one of the following subjects: Biotechnology, Microbiolgy, Genetics, Biochemistry or life sciences. M.B.B.S / B.D.S / B.A.M.S / B.H.M.S / B. Pharmacy/ M. Pharmacy B.E (BT) / B. Tech (BT) Note: Final Year / Pre final students can also apply for the training