PG Certification in Quality Assurance

Installment facility available for fee payment

Category: Postgraduate Courses
Duration : Self paced, recommended to complete in 4 months

Learning objectives

After completion of the course, you will be able to work in QA department with adequate knowledge and good subject understanding. 

Eligibility

B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their Quality Assurance knowledge

Anyone willing to understand this topic can enroll.

Syllabus

  • Section 1: Departments in pharmaceutical industry & responsibilities
    • Depts and responsibilities 30 minutes

  • Section 2: Organogram & its advantage
    • Organogram & its advantage

  • Section 3: Job descriptions of QA functions
    • Job descriptions of QA functions

  • Section 4: Introduction to ICH and ICH Quality guidelines
    • Introduction to ICH & Quality guidelines 103 minutes

  • Section 5: Process flow: receipt of material to dispatch of final product
    • Process flow: receipt of material to dispatch of final product

  • Section 6: Process flow of API and formulation manufacturing
    • Manufacturing process flow of API 66 minutes
    • Manufacturing Process flow: Formulation 75 minutes

  • Section 7: How to write SOP & List of key QA SOPs
    • SOPs 28 minutes
    • Annexure II

  • Section 8: Documents and records generated by QA and their applications
    • Good Documentation Practises, Document management system
    • Annexure I
    • Annexure II
    • Annexure III

  • Section 9: Good Documentation Practices, Document management system
    • Documents and records

  • Section 10: Specifications, Certificate of analysis
    • Specifications, Certificate of analysis 23 minutes
    • Specifications Annexure I - IV
    • COA Annexure

  • Section 11: Data integrity
    • Data integrity

  • Section 12: Vendor/supplier approval
    • Vendor approval
    • Annexure

  • Section 13: Change control
    • Change control
    • Change Control Example

  • Section 14: Deviations
    • Deviations
    • Annexure III

  • Section 15: Validation & qualification, Introduction to process validation, cleaning validation & Analytical method validation
    • Validation

  • Section 16: Internal audit (self-inspection)
    • Internal audit
    • Internal Audit example

  • Section 17: Regulatory audits
    • Regulatory Inspections
    • Questions on all sections

Fees : 11800

Enroll Now
    Course Include :
  • Video
  • PDF
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