Quality Assurance

1.The Quality Assurance (QA) Training Program is designed to equip students and professionals with the fundamental knowledge and practical skills needed to maintain product quality, regulatory compliance, and safety standards in chemical, pharmaceutical, and industrial sectors. This program focuses on Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ISO standards, validation processes, and regulatory guidelines essential for ensuring product integrity and consumer safety.
2.Program Objectives
🔹 Understand Quality Assurance (QA) principles in the pharmaceutical, chemical, and food industries.
🔹 Learn about global regulatory guidelines (FDA, ICH, WHO, ISO, GMP).
🔹 Develop skills in documentation, validation, and compliance auditing.
🔹 Gain expertise in deviation handling, risk management, and CAPA implementation.
🔹 Enhance employability for roles in QA, QC, regulatory affairs, and compliance.

3. Program Structure
A. Course Duration:
• Short-Term Training: 2-4 weeks (Basics, regulatory frameworks, documentation).
• Advanced Training: 3-6 months (In-depth study, practical training, industry exposure).
B. Eligibility:
• M.Sc. Chemistry, M.Pharm, B.Pharm, Chemical Engineering, Biotechnology students.
• Industry professionals looking to advance in QA/QC, regulatory affairs, and compliance.
C. Mode of Training:
• Online / Offline / Hybrid
• Includes theory, case studies, practical laboratory training, and industry visits.

4. Course Modules
Module 1: Fundamentals of Quality Assurance (QA) & Quality Control (QC)
• Introduction to QA & QC – Importance in industries
• Difference between QA & QC
• Role of QA in Pharmaceuticals, Chemicals, and Food Industries
Module 2: Regulatory Compliance & Standards
• International Regulatory Guidelines (ICH, FDA, WHO, EU-GMP, MHRA, TGA)
• ISO Standards (ISO 9001, ISO 17025, ISO 13485 for Medical Devices)
• Pharmaceutical Compliance – ICH Q10, USFDA 21 CFR Part 11
Module 3: Documentation & Validation in QA
• Good Documentation Practices (GDP) – Importance & implementation
• Standard Operating Procedures (SOPs) – Writing & reviewing
• Batch Manufacturing Record (BMR) & Batch Packing Record (BPR)
• Analytical Method Validation – HPLC, GC, UV-Vis, IR
• Equipment Qualification & Calibration (IQ, OQ, PQ)
Module 4: Good Manufacturing Practices (GMP) & Good Laboratory Practices (GLP)
• GMP guidelines for pharmaceuticals & food industries
• GLP principles for chemical & pharmaceutical laboratories
• Handling deviations, out-of-specifications (OOS), and non-conformance
Module 5: Risk Management & Quality Audits
• Quality Risk Management (QRM) principles
• CAPA (Corrective and Preventive Action) – Implementation & effectiveness
• Internal & External Audits – Preparation, execution, and reporting
• Vendor and Supplier Audits – Ensuring compliance
Module 6: Industry Exposure & Practical Training
• Case studies on product recalls & compliance failures
• Hands-on training in Quality Testing & Compliance Software
• Mock GMP & GLP Audits

5. Learning Outcomes
By the end of this training, participants will:
✅ Have a strong understanding of QA principles & regulatory compliance.
✅ Gain practical experience in validation, documentation, and auditing.
✅ Be able to analyze deviations, implement CAPAs, and handle OOS results.
✅ Improve career prospects in QA, QC, regulatory affairs, and compliance.
6. Certification & Career Opportunities
🎓 Certification: Participants will receive a Quality Assurance Training Certificate upon successful completion.
💼 Career Roles:
• Quality Assurance Officer / Executive
• Regulatory Affairs Associate
• Validation Specialist
• GMP/GLP Compliance Officer
• Auditor (Internal / External)