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In the pharmaceutical industry, quality assurance (QA) is essential for ensuring that pharmaceutical products are manufactured to a safe and consistent standard.

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Number of Students:

739

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999.00

This Course Includes

About This Course

This Pharmaceutical Quality Assurance Training Certificate Program is created with the purpose of training and educating freshers as well as experienced industry experts who will have a useful overview of quality assurance methods and procedures after attending the program.

Why Take This Course

The Training Program in Pharmaceutical Quality Assurance teaches how to establish, manage, and oversee quality assurance and quality control procedures for manufacturing and laboratory processes.

The curriculum of this course focuses on the quality standards for biologics and drugs production and control, as well as the differences between quality control and quality assurance, and how they relate to manufacturing.

What You'll Learn

How Will I Learn

Joining and taking the Quality Assurance Course will help you advance your career in Pharma and Biopharma industry by providing you with access to a variety of valuable and instructive pre-recorded lectures by industry expert.

You will be covering unitwise topics in the form of lectures, which will enhance your knowledge on QA fundamentals.

Who Is This For

This course is suitable for candidates interested in joining Pharma and Biopharma industry.:

Certification

All the participants will receive certificates on successful completion of training.

Curriculum

    • 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
    • 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
    • 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
    • 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
    • 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
    • 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 Study-I 00:24:00
    • Case Study-II 00:28:00
    • Case Study-III 00:21:00
    • Case Study-IV 00:38:00

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