Online Diploma in Pharmaceuticals Quality Assurance - Univista EdTech
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Course Overview
The Online Diploma in Pharmaceuticals Quality Assurance by Univista EdTech is a comprehensive program designed to train learners in the principles, standards, and practices that ensure the safety, efficacy, and quality of pharmaceutical products.
This course bridges scientific understanding with regulatory compliance, preparing learners to implement and monitor Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Quality Management Systems (QMS) across the pharmaceutical lifecycle.
It offers a deep dive into validation, documentation, audits, and regulatory frameworks (USFDA, WHO, EMA, CDSCO)—making graduates industry-ready for global pharma and biotech organizations.
15 Months
INR 1,00,000
Intake: Year around admissions
Key Highlights
End-to-end understanding of pharmaceutical quality systems, validation, and compliance.
Learn from industry experts and regulatory professionals in QA and QC.
Exposure to global quality standards such as WHO-GMP, ICH, USFDA, and ISO 9001.
Practical learning through case studies, audit simulations, and documentation exercises.
Integration of AI and digital tools in pharma quality systems.
Capstone project based on a real-world quality assurance case or audit framework.
Ideal for students and professionals in pharmacy, biotechnology, chemistry, and life sciences.
Skills You Will Learn
Quality control and assurance fundamentals in pharmaceutical production.
Understanding and application of GMP, GLP, and GCP guidelines.
Validation and qualification of manufacturing processes and analytical instruments.
Documentation, audit preparation, and deviation handling.
Regulatory compliance and dossier preparation (USFDA, EMA, CDSCO).
Risk assessment, CAPA (Corrective and Preventive Action), and root cause analysis.
Pharmaceutical data integrity and quality-by-design (QbD).
Communication and reporting for QA documentation and audits.
Tools You’ll Master
Course Outcomes
- Gain comprehensive understanding of QA processes within pharmaceutical manufacturing.
- Apply GMP and regulatory standards to ensure product safety and compliance.
- Develop documentation and audit readiness for local and international inspections.
- Build capability to handle quality risk management and root cause investigations.
- Prepare for QA roles in production, validation, auditing, and compliance functions.
Learning Outcomes
- By completing this diploma, learners will be able to:
- Implement quality systems aligned with international pharmaceutical standards.
- Evaluate and validate processes to ensure consistent product performance.
- Maintain accurate documentation for regulatory submissions and audits.
- Identify, analyze, and mitigate quality risks in manufacturing and testing.
- Manage cross-functional coordination between production, R&D, and QA teams
Key Outcomes
- Professional certification in Pharmaceutical Quality Assurance from Univista EdTech.
- Portfolio of practical QA projects including audit simulations and validation studies.
- Job readiness for positions such as Quality Assurance Officer, Validation Executive, Regulatory Associate, or Compliance Specialist.
- Strong foundation for global roles in pharma, biotech, and contract research organizations (CROs).
- Awareness of current regulatory trends, sustainability, and digital quality systems.
Course Curriculum
Module 1
Introduction to Pharmaceutical Industry & Quality Assurance Principles
Module 2
Good Manufacturing Practices (GMP) & Good Laboratory Practices (GLP)
Module 3
Quality Management Systems (QMS) and ISO Standards
Module 4
Process Validation, Qualification & Calibration
Module 5
Pharmaceutical Documentation and Data Integrity
Module 6
Audits, Inspections, and Regulatory Compliance (USFDA, EMA, WHO, CDSCO)
Module 7
Risk Management, CAPA, and Change Control
Module 8
Pharmaceutical Packaging, Labelling & Stability Studies
Module 9
Digital Quality Systems, LIMS, and Industry 4.0 in Pharma QA
Module 10
Capstone Project – Quality Audit Simulation or GMP Compliance Framework
Why You Should Join this Course
- Global Industry Relevance: QA professionals are the backbone of regulatory compliance in every pharmaceutical company.
- Career Versatility: Prepare for roles in QA, validation, documentation, auditing, or regulatory affairs.
- Hands-On Learning: Apply quality systems and tools through simulations and case-based assignments.
- Regulatory Edge: Understand global pharma guidelines — USFDA, EMA, WHO-GMP, and ISO.
- Tech-Enabled Future: Learn about automation, AI, and digital transformation in pharma QA.
- Powered by Univista EdTech: A trusted platform delivering futuristic, industry-aligned, and employability-focused education, preparing you to excel in the global pharmaceutical ecosystem.
₹1,00,000
Admissions Open
Eligibility
- Minimum Qualification: 10+2 (High School) or equivalent
- Open to graduates, working professionals, and entrepreneurs
Admission Criteria
- Online application submission
- Document verification (education + ID proof)
- Admission confirmation after fee payment
