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Course Curriculum
| Unit-I: Pharmaceuticals Quality Assurance (QA) | |||
| 1.1 Pharmaceutical QA-Introduction | 00:12:00 | ||
| 1.2 Concepts & Definition of QA | 00:04:00 | ||
| 1.3 Pharmaceutical QA-Overview | 00:21:00 | ||
| 1.4 Role & Function of QA | 00:11:00 | ||
| 1.5 Function of QA | 00:20:00 | ||
| 1.6 QA Document Control – Part 1 | 00:19:00 | ||
| 1.7 QA Document Control – Part 2 | 00:13:00 | ||
| 1.8 Format of Standard Operating Procedure | 00:06:00 | ||
| 1.9 Log Book Preparation & Maintenance | 00:28:00 | ||
| 1.10 Validation & Maintenance of Records | 00:12:00 | ||
| 1.11 Validation Master Plan – Part 1 | 00:16:00 | ||
| 1.12 Validation Master Plan – Part 2 | 00:04:00 | ||
| 1.13 Types of Process Validation – Part 1 | 00:06:00 | ||
| 1.14 Types of Process Validation – Part 2 | 00:15:00 | ||
| 1.15 Definition & Terminology | 00:41:00 | ||
| Unit-2: Quality Management system (QMS) | |||
| 2.1 Quality Management system (QMS)- Overview | 00:15:00 | ||
| 2.2 Definitions & Benefits | 00:13:00 | ||
| 2.3 Benefits of QMS | 00:05:00 | ||
| 2.4 ISO Certification | 00:08:00 | ||
| 2.5 Seven Quality Management Principles | 00:04:00 | ||
| 2.6 Process of ISO 9001-2015 QMS – Part 1 | 00:15:00 | ||
| 2.7 Process of ISO 9001-2015 QMS – Part 2 | 00:11:00 | ||
| 2.8 Process of ISO 9001-2015 QMS – Part 3 | 00:14:00 | ||
| 2.9 Process of ISO 9001-2015 QMS – Part 4 | 00:37:00 | ||
| 2.10 Environmental Management System Standard | 00:20:00 | ||
| 2.11 NABL Accreditation | 00:13:00 | ||
| 2.12 Why is NABL Accreditation required | 00:13:00 | ||
| 2.13 Eligibility Criteria for NABL Accreditation | 00:08:00 | ||
| 2.14 Procedure for approval for NABL Accreditation | 00:10:00 | ||
| 2.15 Benefits of NABL Accreditation | 00:08:00 | ||
| Unit-3: Total Quality Management (TQM) | |||
| 3.1 Introduction of Total Quality Management (TQM) | 00:08:00 | ||
| 3.2 Elements & Significance of TQM | 00:20:00 | ||
| 3.3 Tools of TQM | 00:14:00 | ||
| 3.4 Tools of TQM (Pie Chart)- Part 2 | 00:13:00 | ||
| 3.5 Tools of TQM (Histogram, Pareto Chart, Force Fied Analyses)- Part 3 | 00:13:00 | ||
| 3.6 Tools of TQM (Affinity & Brainstorming Chart, Tree Diagram)- Part 4 | 00:11:00 | ||
| 3.7 Tools of TQM (Flow diagram, Scatter Diagram, Relation Diagram, PDCA)- Part 5 | 00:12:00 | ||
| 3.8 Why TQM fails | 00:12:00 | ||
| 3.9 Other reason of TQM failure | 00:11:00 | ||
| 3.10 Benefits of TQM | 00:05:00 | ||
| Unit-4 Pharmaceutical Regulations | |||
| 4.1 Understanding of Regulations & Guidelines | 00:08:00 | ||
| 4.2 Regulatory Bodies | 00:12:00 | ||
| 4.3 Scope of Regulatory Organizations; EU, US & Other countries Regulations – Part1 | 00:11:00 | ||
| 4.4 Scope of Regulatory Organizations; Indian & International Regulations & Guidelines – Part 2 | 00:20:00 | ||
| 4.5 Role & Challenges of Regulatory Bodies | 00:07:00 | ||
| 4.6 Drug Regulatory Authority | 00:17:00 | ||
| 4.7 Regulatory Affairs & their role in product development cycle | 00:18:00 | ||
| 4.8 CTD Pyramid | 00:04:00 | ||
| 4.9 Role of RA in product development cycle – Art Work and Label Management – Part 1 | 00:11:00 | ||
| 4.10 Role of RA in product development cycle – Art Work and Label Management – Part 2 | 00:15:00 | ||
| 4.11 Role of RA in product development cycle – Other Roles – Part 3 | 00:06:00 | ||
| 4.12 Why need to regulate | 00:06:00 | ||
| 4.13 Practices to Adopt | 00:16:00 | ||
| 4.14 Why we need good practices | 00:04:00 | ||
| 4.15 GMP and cGMP | 00:19:00 | ||
| 4.16 7 steps to GMP Compliance | 00:12:00 | ||
| 4.17 21 CFR Part 210 and 211 | 00:36:00 | ||
| 4.18 cGMP Guidelines- USFDA cGMP | 00:19:00 | ||
| 4.19 cGMP Guidelines- ICH cGMP, WHO cGMP, EMA cGMP | 00:16:00 | ||
| 4.20 cGMP Guidelines- Schedule M in India | 00:10:00 | ||
| 4.21 cGMP Guidelines- International cGMP Guidelines | 00:16:00 | ||
| 4.22 Good Lab Practices & cGLPs | 00:11:00 | ||
| 4.23 Good Clinical Practices & cGCPs | 00:14:00 | ||
| 4.24 Good Distribution Practice & cGDP | 00:22:00 | ||
| 4.25 Pharmaceutical Supply Chain | 00:15:00 | ||
| 4.26 What is Cold Chain | 00:08:00 | ||
| 4.27 Good Storage Practices & cGSPs | 00:22:00 | ||
| 4.28 Good Documentation Practice & cGDocP- Part 1 | 00:16:00 | ||
| 4.29 Good Documentation Practice & cGDocP- Part 2 | 00:16:00 | ||
| 4.30 Good Practices- Sanitization and Hygiene- Part 1 | 00:23:00 | ||
| 4.31 Premises Sanitation | 19:00:00 | ||
| 4.32 Equipment Cleaning and Sanitation | 00:16:00 | ||
| 4.33 Segregation of BioMedical Waste- Part 1 | 00:08:00 | ||
| 4.34 Segregation of BioMedical Waste- Part 2 | 00:06:00 | ||
| 4.35 ICH Guidelines Purpose | 00:09:00 | ||
| 4.36 Steps of ICH Guidelines Harmonization | 00:07:00 | ||
| 4.37 ICH Guideliines- Categories & Codes | 00:05:00 | ||
| 4.38 ICH Quality (Q) Guidelines – Part 1 | 00:14:00 | ||
| 4.39 ICH Stability Zones & Testing Conditions | 00:10:00 | ||
| 4.40 ICH Quality (Q) Guidelines- Part 2 | 00:08:00 | ||
| 4.41 ICH Quality (Q) Guidelines- Part 3 | 00:10:00 | ||
| 4.42 ICH Safety (S) Guidelines – Part 1 | 00:08:00 | ||
| 4.43 ICH Safety (S) Guidelines – Part 2 | 00:12:00 | ||
| 4.44 ICH Efficacy (E) Guidelines | 00:15:00 | ||
| 4.45 ICH Multidisciplinary (M) Guidelines | 00:12:00 | ||
| Unit-5 Quality by Design | |||
| 5.1 Quality by Design- An Overview | 00:13:00 | ||
| 5.2 Components of QM Process | 00:07:00 | ||
| 5.3 Juran’s Trilogy | 00:12:00 | ||
| 5.4 QbD-Cocept, Objective & Background | 00:05:00 | ||
| 5.5 Essential Elements of QbD – Part 1 | 00:18:00 | ||
| 5.6 Essential Elements of QbD – Part 2 | 00:11:00 | ||
| 5.7 Application of QbD – Part 1 | 00:18:00 | ||
| 5.8 Application of QbD – Part 2 | 00:09:00 | ||
| 5.9 Advantages of QbD – Part 1 | 00:11:00 | ||
| 5.10 Advantages of QbD – Part 2 | 00:09:00 | ||
| Unit-6 Data Integrity | |||
| 6.1 Data Integrity- Introduction Part 1 | 00:11:00 | ||
| 6.2 Data Integrity- Introduction Part 2 | 00:13:00 | ||
| 6.3 Types of Data – Part 1 | 00:12:00 | ||
| 6.4 Types of Data – Part 2 | 00:07:00 | ||
| 6.5 Benefits & Consequences of Data Integrity | 00:14:00 | ||
| 6.6 Role of QA in Data Integrity | 00:17:00 | ||
| 6.7 Data Integrity Alignment with Work Flow | 00:14:00 | ||
| 6.8 Data Integrity Principle | 00:12:00 | ||
| 6.9 How to Ensure Data Integrity | 00:05:00 | ||
| 6.10 How to Ensure Data Integrity – Contd | 00:19:00 | ||
| 6.11 Four ways to ensure Data Integrity | 00:11:00 | ||
| 6.12 Data Integrity Issues and Examples | 00:17:00 | ||
| 6.13 Factor minimizing the risk of Data Integrity | 00:15:00 | ||
| 6.14 Contents of Warning Letter | 00:27:00 | ||
| 6.15 Implementation of Data Integrity | 00:09:00 | ||
| Case Studies | |||
| Case Study-I | 00:24:00 | ||
| Case Study-II | 00:28:00 | ||
| Case Study-III | 00:21:00 | ||
| Case Study-IV | 00:38:00 | ||