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Course / Course Details

Quality Assurance & Quality Management [QA-QM]

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 0 students
  • 3 Hours
  • (0)

Course Requirements

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.


Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This course will cover Introduction to QA profession, GMP/GLP, Introduction to ICH guidance and Emphasis on ICH Q 7, Quality Assurance and Regulatory Affairs, Documentation requirements as per GMP compliance, Audit Preparations, Writing SOPs, PICs guidance.

Course Curriculum

  • 8 chapters
  • 119 lectures
  • 8 quizzes
  • 3 Hours total length
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1 SOP for QA-QM
15 Min

2 Important Guidance and Articles
15 Min

1 General Overview of the Pharmaceutical Industry, its functioning, role of various departments within the industry.
15 Min

2 PPT
15 Min

3 Quality Assurance/ Quality Control Profession, Role and its importance in Pharmaceutical Industry
15 Min

4 Articles 1.1
15 Min

5 Articles 1.2
15 Min

6 Articles 1.3
15 Min

7 QA- Video
1 Min

8 Notes 1.1
15 Min

9 Notes 1.2
15 Min

10 Notes 1.3
15 Min

11 MCQs 1 [Quiz]
5 Min

1 Overview of GMP
15 Min

2 Overview of GLP
15 Min

3 Guidance 1.1
15 Min

4 Guidance 1.2
15 Min

5 Video on 10 Principles of GMP
1 Min

6 PPT
15 Min

7 How to implement GxP system PPT
15 Min

8 How to implement GxP System Lecture Video by Rajashri Ojha 1.1
1 Min

9 How to implement GxP System Lecture Video by Rajashri Ojha 1.2
1 Min

10 Data Integrity Video 1
1 Min

11 Data Integrity Video 2
1 Min

12 Data Integrity Video 3
1 Min

13 Data Integrity Video 4
1 Min

14 Data Integrity Video 5
1 Min

15 Good documentation practice videos 1
1 Min

16 Good documentation practice videos 2
1 Min

17 Good documentation practice videos 3
1 Min

18 Good documentation practice videos 4
1 Min

19 Good Documentation Practice-Lecture by Rajashri Ojha
1 Min

20 MCQs 2 [Quiz]
5 Min

21 Notes
15 Min

1 Introduction to ICH
15 Min

2 Validation
15 Min

3 Design of water systems and HVAC
15 Min

4 PPT 1
15 Min

5 PPT 2
15 Min

6 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients-question and answer
15 Min

7 ICh guidelines - Q1A_R2_Guideline
15 Min

8 ICh guidelines - Q1B_Guideline
15 Min

9 ICh guidelines - Q1C_Guideline
15 Min

10 ICh guidelines - Q1D_Guideline
15 Min

11 ICh guidelines - Q1E_Guideline
15 Min

12 ICh guidelines - Q2 R1 Guideline
15 Min

13 ICh guidelines - Q3A_R2__Guideline
15 Min

14 ICh guidelines - Q3B R2 Guideline
15 Min

15 ICh guidelines - Q3C-R7
15 Min

16 ICh guidelines - Q3D-R1EWG Document Step4 Guideline 2019
15 Min

17 ICh guidelines -Q4B_Guideline
15 Min

18 ICh guidelines - Q5A R1 Guideline
15 Min

19 ICh guidelines - Q5B_Guideline
15 Min

20 ICh guidelines - Q6A
15 Min

21 ICh guidelines - Q6B
15 Min

22 ICh guidelines - Q7_Guideline
15 Min

23 ICh guidelines - Q9_Guideline
15 Min

24 ICh guidelines - Q10_Guideline
15 Min

25 ICh guidelines - Q11
15 Min

26 ICh guidelines - Q12
15 Min

27 Video-ICH Q1-1
1 Min

28 Video-ICH Q1-2
1 Min

29 Video- ICH Q2-1
1 Min

30 Video- ICH Q2-2
1 Min

31 Video -ICH Q3-1
1 Min

32 Video -ICH Q3-2
1 Min

33 ICH Q6-1
1 Min

34 ICH Q6-2
1 Min

35 ICH Q9-1
1 Min

36 ICH Q9-2
1 Min

37 ICH Q10-1
1 Min

38 ICH Q10-2
1 Min

39 MCQs 3 [Quiz]
5 Min

40 Notes
15 Min

1 Documentation requirements for GMP compliance
15 Min

2 GMP - a study of Schedule M of D & C Act, WHO requirements, USFDA guidelines.
15 Min

3 Warehousing requirements: Raw, Packaging and finished requirements
15 Min

4 Various aspects of QA like - Complaints and recalls, change controls, deviation controls, vendor approvals
15 Min

5 Handling of returned goods and Reprocessing and Recoveries
15 Min

6 Annual product review
15 Min

7 Handling of Out of Specification (OOS) Test Results
15 Min

8 Deviation report system
15 Min

9 Guidance
15 Min

10 PPT
15 Min

11 Analytical Method video
1 Min

12 Notes 1.1
15 Min

13 Notes 1.2
15 Min

14 Notes 1.3
15 Min

15 Notes 1.4
15 Min

16 Notes 1.5
15 Min

17 MCQs 4 [Quiz]
5 Min

1 Evaluation of GMP compliance to International Regulatory Standards
15 Min

2 Formulation and API’s to face Quality Audits such as WHO, USFDA, EDQM, MHRA, FDA etc.
15 Min

3 Vendor Audit
15 Min

4 Guidance
15 Min

5 PPT
15 Min

6 PPT 2
15 Min

7 Supplier and Internal Audit Video 1.1
1 Min

8 Supplier and Internal Audit Video 1.2
1 Min

9 Notes 1.1
15 Min

10 Notes 1.2
15 Min

11 MCQs 5 [Quiz]
5 Min

1 The Role of SOP’s in Quality Documentation Systems
15 Min

2 Good Documentation practices
15 Min

3 Use various tools such as flowcharting to define a logical procedure
15 Min

4 Write a concise, unambiguous SOP for its intended purpose
15 Min

5 Writing for the correct audience
15 Min

6 Link SOPs to good documentation practices
15 Min

7 Manage revisions, non conformance and deviations from a current SOP
15 Min

8 ABBREVIATION
15 Min

9 Guidance's 1.1
15 Min

10 Guidance's 1.2
15 Min

11 SOP video
1 Min

12 SOP fundamental -video
1 Min

13 Notes 1.1
15 Min

14 Notes 1.2
15 Min

15 MCQs 6 [Quiz]
5 Min

1 Final Exam 1 [Quiz]
1 Hour 20 Min

2 Final Exam 2 [Quiz]
1 Hour 40 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 119 lessons

  • Enrolled 0 students

  • Category: Pharmaceuticals

  • 8 Quizzes

  • Language: English

  • Skill Level Regular Courses

  • Certificate of Completion

  • 90 Days Access

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