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Course / Course Details

Certificate Course in Formulation

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 0 students
  • 3 Hours
  • (0)

Course Requirements

B.Pharm/M.Pharm/PhD/BSc/MSc/
B.Tech/M.Tech/Pharma, Healthcare Working Professionals.

Course Curriculum

  • 12 chapters
  • 202 lectures
  • 11 quizzes
  • 3 Hours total length
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1 SOP for Formulation
15 Min

2 Step by Step Procedure for the course
1 Min

3 Important Guidance and Articles
15 Min

1 RA Profession
15 Min

2 Articles 1 - RA
15 Min

3 Articles 2 - Document
15 Min

4 Articles 3 - Issue
15 Min

5 PPT
15 Min

6 Regulatory affairs Video
1 Min

7 Lecture Video by Rajashri Ojha Video
1 Min

8 Regulatory Video 1
1 Min

9 Regulatory Video 2
1 Min

10 PPT 2
15 Min

11 MCQs 1 [Quiz]
10 Min

1 Drug Development
15 Min

2 Pharmacovigilance
15 Min

3 GVP, EVMPD & XEVMPD
15 Min

4 Drug Development Process Video
1 Min

5 Clinical Trails in India video
1 Min

6 PPT
15 Min

7 Mayur Kanchalwar Lecture - Clinical Trial - Video 1
1 Min

8 Mayur Kanchalwar Lecture - Clinical Trial - Video 2
1 Min

9 Mayur Kanchalwar Lecture - Clinical Trial - Video 3
1 Min

10 Mayur Kanchalwar Lecture Pharmacovigilance Video 1
1 Min

11 Mayur Kanchalwar Lecture Pharmacovigilance Video 2
1 Min

12 Mayur Kanchalwar Lecture Pharmacovigilance Video 3
1 Min

13 Mayur Kanchalwar Lecture Pharmacovigilance Video 4
1 Min

14 MCQs 2 [Quiz]
10 Min

1 Formulation
15 Min

2 Importance of Pre formulation Studies and Planning
15 Min

3 PDR WRITING AS PER ICH Q8
15 Min

4 PPT
15 Min

5 PDR by Dr Parizad madam video 1
1 Min

6 PDR by Dr Parizad madam video 2
1 Min

7 PDR by Dr Parizad madam video 3
1 Min

8 PDR by Dr Parizad madam video 4
1 Min

9 Product Developement-Rajashri Ojha-Lecture Video 1
1 Min

10 Product Developement-Rajashri Ojha-Lecture Video 2
1 Min

11 Product Development- Rajashri Ojha PPT
15 Min

12 MCQs 3 [Quiz]
10 Min

1 History of FDA and Related Regulatory Agencies
15 Min

2 FDA Organization
15 Min

3 Investigational New Drug Application
15 Min

4 New Drug Application
15 Min

5 National Drug Code Directory
15 Min

6 Generic Drug Submissions
15 Min

7 GUIDANCE FOR INDUSTRY
15 Min

8 Over-the-Counter Drug Products
15 Min

9 Patents and Exclusivity
15 Min

10 Prescription Drug Labeling, Advertising and Promotion
15 Min

11 Para IV Video
1 Min

12 FDA Inspection Video
1 Min

13 FDA Drug Approval Process Video
1 Min

14 ANDA PPT
15 Min

15 ANDA Video
1 Min

16 Drug Regulatory Submission-USFDA by Rajashri Ojha video 1
1 Min

17 Drug Regulatory Submission-USFDA by Rajashri Ojha video 2
1 Min

18 Regulation for OTC PPT
15 Min

19 Guidance/Articles for OTC 1
15 Min

20 Guidance/Articles for OTC 2
15 Min

21 Video-Regulation for OTC-Lecture by Rajashri Ojha
1 Min

22 Drug Regulation in US lecture Video 1
1 Min

23 Drug Regulation in US lecture Video 2
1 Min

24 Drug Regulation in US lecture Video 3
1 Min

25 Drug Regulation in US lecture Video 4
1 Min

26 MCQs 4 [Quiz]
10 Min

1 Pharmaceuticals in the European
15 Min

2 EUDRALEX: EU Pharmaceutical Legislation
15 Min

3 Regulation of medicines in the European Union
15 Min

4 Marketing Authorization
15 Min

5 Variation
15 Min

6 EU Drug Regulatory System basic video
15 Min

7 Product life cycle management
15 Min

8 EU Variation video 1
1 Min

9 EU Variation video 2
1 Min

10 EU Variation video 3
1 Min

11 IDMP and SPOR
15 Min

12 Marketing Authorization Video
1 Min

13 PPT
15 Min

14 Regulatory System in Europe by Surekha Amrutkar-Lecture Video 1
1 Min

15 Regulatory System in Europe by Surekha Amrutkar-Lecture Video 2
1 Min

16 Regulatory System in Norway video
1 Min

17 Drug Regulation in EU Lecture Video 1
1 Min

18 Drug Regulation in EU Lecture Video 2
1 Min

19 MCQs 5 [Quiz]
10 Min

1 Introduction
15 Min

2 Registration with ASEAN Countries
15 Min

3 REGISTRATION WITH MIDDLE EAST COUNTRIES
15 Min

4 REGISTRATION WITH LATIN AMERICA
15 Min

5 Registration in Emerging market (India, Russia, China, Japan, South Africa)
15 Min

6 PPT
15 Min

7 ROW - Lecture Video 1
15 Min

8 ROW - Lecture Video 2
15 Min

9 ROW - Lecture Video 3
15 Min

10 ROW - Lecture Video 4
15 Min

11 PPT-Roadmap to Africa
15 Min

12 1-Lecture Video-Roadmap to Africa
15 Min

13 2-Lecture Video-Roadmap to Africa
15 Min

14 3-Lecture Video-Roadmap to Africa
15 Min

15 Vietnam- Regulatory System Video
15 Min

16 MCQs 6 [Quiz]
10 Min

1 Introduction
15 Min

2 Article
15 Min

3 ICH Q1 video 1
15 Min

4 ICH Q1 video 2
15 Min

5 ICH Q2 video 1
15 Min

6 ICH Q2 video 2
15 Min

7 ICH Q3 Video 1
15 Min

8 ICH Q3 Video 2
15 Min

9 ICH Q6 Video 1
15 Min

10 ICH Q6 Video 2
15 Min

11 ICH Q9 Video 1
15 Min

12 ICH Q9 Video 2
15 Min

13 M7 genotoxic impurities- video
15 Min

14 ICH Guidelines 1
15 Min

15 ICH Guidelines 2
15 Min

16 ICH Guidelines 3
15 Min

17 ICH Guidelines 4
15 Min

18 ICH Guidelines 5
15 Min

19 ICH Guidelines 6
15 Min

20 ICH Guidelines 7
15 Min

21 ICH Guidelines 8
15 Min

22 ICH Guidelines 9
15 Min

23 ICH Guidelines 10
15 Min

24 ICH Guidelines 11
15 Min

25 ICH Guidelines 12
15 Min

26 ICH Guidelines 13
15 Min

27 ICH Guidelines 14
15 Min

28 ICH Guidelines 15
15 Min

29 ICH Guidelines 16
15 Min

30 ICH Guidelines 17
15 Min

31 ICH Guidelines 18
15 Min

32 ICH PPT Q1 Stability
15 Min

33 ICH PPT Q6 Specification
15 Min

34 ICH Guidance-by Arvind Kadam
15 Min

35 ICH Guidance by Arvind Kadam-Lecture Video 1
15 Min

36 ICH Guidance by Arvind Kadam-Lecture Video 2
15 Min

37 ICH Guidance by Arvind Kadam-Lecture Video 3
15 Min

38 Analytical Validation PPT -Arvind Kadam
15 Min

39 Analytical Validation Lecture by Arvind Kadam Video - 1
15 Min

40 Analytical Validation Lecture by Arvind Kadam Video - 2
15 Min

41 Analytical Validation Lecture by Arvind Kadam Video - 3
15 Min

42 Analytical Validation Lecture by Arvind Kadam Video - 4
15 Min

43 MCQs 7 [Quiz]
10 Min

1 GMP
15 Min

2 GLP, GCP
15 Min

3 PPT
15 Min

4 Good Documentation Practice PPT
15 Min

5 Good Documentation practice Video
15 Min

6 GMP and GLP Videos
15 Min

7 10 Principle of GMP video
15 Min

8 GCP Video
15 Min

9 GMP Lecture Video 1
15 Min

10 GLP Lecture Video 2
15 Min

11 How to implement GxP system in Pharma, Medical Device Industry PPT
15 Min

12 How to implement GxP System By Rajashri Ojha Lecture Video 1
15 Min

13 How to implement GxP System By Rajashri Ojha Lecture Video 2
15 Min

14 Validation and Qualification Lecture Video - 1
15 Min

15 Validation and Qualification Lecture Video - 2
15 Min

16 Validation and Qualification Lecture Video - 3
15 Min

17 PPT-GMP Lecture by Arvind Kadam
15 Min

18 cGMP lecture Video 1
15 Min

19 cGMP lecture Video 2
15 Min

20 MCQs 8 [Quiz]
10 Min

1 Dossier Preparation
15 Min

2 DOSSIER PREPARATION IN pCTD AND eCTD FORMAT
15 Min

3 CTD
15 Min

4 Quality Module Part 3S-drug substance
15 Min

5 Quality Module Part 3P-drug
15 Min

6 PPT 1 - Overview of eCTD
15 Min

7 PPT 2 - Webinar-eCTD-Overview
15 Min

8 Guidance 1
15 Min

9 Guidance 2
15 Min

10 CTD triangle video
15 Min

11 Lecture Video
15 Min

12 Concept of eCTD video 1
15 Min

13 Concept of eCTD video 2
15 Min

14 Video-overview and Organization of ectd by Rajahri Oja
15 Min

15 CMC in Detail Video 1
15 Min

16 CMC in Detail Video 2
15 Min

17 eCTD Software demo Video 1
15 Min

18 eCTD Software demo Video 2
15 Min

19 eCTD Software demo Video 3
15 Min

20 Technical Writing Skills
15 Min

21 Basic of CMC and Scientific and regulatory writing skills video 1
15 Min

22 Basic of CMC and Scientific and regulatory writing skills video 2
15 Min

23 Basic of CMC and Scientific and regulatory writing skills video 3
15 Min

24 Organization of CTD video 1
15 Min

25 Organization of CTD video 2
15 Min

26 Organization of CTD video 3
15 Min

27 MCQs 9 [Quiz]
10 Min

1 21 CFR part 11
15 Min

2 Guidance
15 Min

3 Data integrity PPT and Guidance 1
15 Min

4 Data integrity PPT and Guidance 2
15 Min

5 Lecture Video Data Integrity - 1
15 Min

6 Lecture Video Data Integrity - 2
15 Min

7 Lecture Video Data Integrity - 3
15 Min

8 Lecture Video Data Integrity - 4
15 Min

9 Lecture Video Data Integrity - 5
15 Min

10 MCQs 10 [Quiz]
10 Min

1 Final Exam RA Formulation [Quiz]
1 Hour 40 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 202 lessons

  • Enrolled 0 students

  • Category: Pharmaceuticals

  • 11 Quizzes

  • Language: English

  • Skill Level Long Courses

  • Certificate of Completion

  • 120 Days Access

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