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Pharma Quality Assurance Certificate Course

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

Ratings:

4.4

Number of Students: 1195

Created By: Ms. Shefali Jadhav (QA SME )

Just 2 Seats Remaining
18 out of 20 Enrolled Already
Original price was: ₹4,999.Current price is: ₹699.
Buy This Course

This Course Includes

  • Certificate of Completion
  • 30 Hours Video Content
  • Lifetime Access
  • Self-Paced Learning

What You'll Learn

  • Pharmaceuticals Quality Assurance
  • Quality Management system (QMS)
  • Total Quality Management (TQM)
  • Pharmaceutical Regulations
  • Quality by Design
  • Data Integrity

Who Is This For

This course is suitable for currently enrolled students or pass-out students.

  • Biological Science, Biotechnology, Microbiology, Molecular Biology and other relevant qualification in the Life Sciences.
  • This course is also suitable for Pharmacy candidates with BPharma or MPharma.
  • Employed candidates looking for career upgradation can also take this program.

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.

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.

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

Reviews

  1. Nirali GiraseNovember 23, 2023 at 9:37 PM
    it's top quality course
    5

    Good course, Excellent tutor

  2. Malli RobinsonNovember 13, 2023 at 11:09 AM
    very good
    5

    this coarse was very good to learn and gain knowledge.

  3. Shruti PabaleNovember 11, 2023 at 10:18 AM
    Informative lectures
    5

    Useful lectures are there

  4. EDWIN LEO JOSEPHNovember 8, 2023 at 8:12 PM
    PQAP program
    5

    It was a good one , the case studies should have been even more with the scenarios in day to day problems of industrial working of QA n QC / lab

  5. Mohit AngolkarNovember 2, 2023 at 11:35 AM
    Pharma Quality Assurance
    5

    Very informative and value-added course!

  6. Sharanya ParamshettiNovember 2, 2023 at 11:28 AM
    Pharma Quality Assurance Program
    5

    Excellent course

  7. Latishka HemoriOctober 31, 2023 at 8:05 PM
    Pharmaquality assurance program
    5

    Good experience nice course

  8. Jasmin JOctober 31, 2023 at 1:15 PM
    Pharma assurance
    5

    The course was effective, easy to follow up

  9. Keerti BasutkarOctober 30, 2023 at 11:27 AM
    complete course
    5

    its was good and easily understanding

  10. Ummehawa HamdulayOctober 9, 2023 at 8:35 PM
    Course review
    5

    It was a really nice experience

  11. Yashaswi SinghOctober 5, 2023 at 12:13 AM
    How's the experience?
    5

    Good and innovative learning classes

  12. Iqra Azim MullaSeptember 30, 2023 at 9:07 PM
    pharma quality assurance program
    5

    The course was worth it.
    How to download the certificate?

  13. Vaibhav MhetreSeptember 21, 2023 at 11:20 PM
    Knowledge about Pharma QA
    5

    Got basic knowledge about QA

  14. riyana.abreoSeptember 14, 2023 at 11:35 AM
    quality assurance course
    5

    I really enjoyed the session. The information provided in all the classes were knowledgeable.

  15. Supriti GiriAugust 8, 2023 at 9:30 AM
    about course
    5

    good course

  16. Jinal PrajapatiAugust 1, 2023 at 11:24 PM
    Learning course
    5

    Such a Nice Course. Many topics are learned from this course.

  17. SREEJANI SENJuly 28, 2023 at 8:40 PM
    Great course
    5

    It was awesome learning from you

  18. Satyaprakash RanaJuly 13, 2023 at 11:25 PM
    Really good
    5

    This is a great opportunity fr students who’s are unable to continue intern along with their academics.Great experience with biogrademy

  19. DnyaneshwarJune 26, 2023 at 11:05 PM
    Good experience
    5

    Expert training

  20. MansirastogiJune 25, 2023 at 11:56 AM
    pharma quality assurance
    5

    very knowledgeable nd good one

  21. Sailee P. GardiJune 6, 2023 at 11:15 AM
    Detailed overview
    5

    I really liked how all things are explained

  22. kavinya kuttimaMay 30, 2023 at 9:45 PM
    fabulous
    5

    it was easy to understand… and we learn each and everything

  23. Pranaya kumar MahapatroMay 7, 2023 at 6:53 PM
    Excellent
    5

    Learn new things about the QA and QC

  24. Ishika SinghApril 24, 2023 at 12:55 AM
    Best platform
    5

    This is the best platform for certification courses

  25. Jayesh Ravindra PatilApril 11, 2023 at 5:51 PM
    nice and help full course
    5

    it help me to understand who pharmaceutical company actually works

  26. Pappu KumarMarch 9, 2023 at 5:57 PM
    Best course
    5

    Easy to study and understand 😃

  27. Dhananjay Machhindra DherangeFebruary 25, 2023 at 11:18 AM
    Course completed
    5

    Good for getting knowledge of qa

  28. Palak .January 12, 2023 at 6:52 PM
    Excellent
    5

    I have learnt so much from this course

  29. KARNATI RENUKANovember 21, 2022 at 2:31 PM
    Good course
    5

    Helpful,thank you for valuable training

  30. Shweta SinghNovember 1, 2023 at 8:37 PM
    Satisfied
    4

    Faced a little bit problem in the beginning while login but after that I learnt so many new things through this course

  31. MITHIL RANESeptember 24, 2023 at 7:31 PM
    Good course
    4

    Good course

  32. VIGNESH NSeptember 16, 2023 at 12:57 AM
    Student
    4

    This course makes the learner to understand about basics much , really amazing and was very helpful.It is highly useful to the person who wants to just brush up with the knowledge

  33. Sakshi Sudhakar PatilJuly 31, 2023 at 12:03 AM
    Excellent experience
    4

    Good course. It gives us basic knowledge about how QA and QC works contains all information about Gxps. Anyone who wishes to join Pharma industry or any chemical manufacturing company it will surely be a great knowledge booster course for them.

  34. Sibarpita TripathyJuly 14, 2023 at 8:39 PM
    Really good
    4

    This is a great opportunity fr students who’s are unable to continue intern along with their academics.Great experience with biogrademy

  35. Shubham RajJuly 14, 2023 at 1:31 PM
    very efficient and informative
    4

    the course is well organised and informative

  36. Athulya VenuJune 15, 2023 at 7:45 PM
    Q A course
    4

    It was very helpful in understanding more about QA as a fresher.

  37. Disha ShindeApril 4, 2023 at 10:22 PM
    Great experience
    4

    It was a good experience of learning with Biogrademy. Good content 👍

  38. Sannala Hima varshiniMarch 29, 2023 at 4:45 PM
    Pharma quality assurance program
    4

    Good nice explanation

  39. CHANDA BHAVANANovember 21, 2022 at 2:35 PM
    GREAT COURSE!!
    4

    this course was very helpful and easy to understand. Everything was clear and the contents were informative.

  40. Anchal SharmaOctober 15, 2022 at 6:48 PM
    Knowledgeable course.
    4

    Course was quite knowledgable and i learnt a lot of new concept regarding Quality Assurance in Pharmaceutical Industries.

  41. Kriti OjhaOctober 1, 2023 at 8:09 PM
    Helpful course
    3

    Loved the case studies discussed at the end of the course providing useful information about how the QA QC work in pharmas work like.Highly recommended

  42. Priyanshi RoshanJune 8, 2023 at 12:31 AM
    Informative
    3

    Nice to deepen the knowledge in the field. Good exposure for a general idea in this.

  43. Burhanuddin MadriwalaMarch 10, 2024 at 12:12 PM
    Pharmaceutical Quality Assurance
    2

    Instructor should be more clear about the concepts and explanation.

  44. Rasika SelvarajJune 14, 2023 at 1:01 PM
    About course
    2

    The way of explanation is good and I learn more through this course.

  45. Preeti YadavJanuary 6, 2024 at 12:41 AM
    Quality Assurance in Pharmaceuticals
    1

    Good course

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