Loading ...

Course / Course Details

Regulatory Affairs in API [Active Pharmaceutical Ingredients]

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 0 students
  • 1 Hour 30 Min
  • (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 RA profession, Characterization and Polymerization of API, Drug Substance Regulation(DMF/ASMF/CEP), Regulation in semi regulated countries, DMF submission in CTD/ ACTD format, 21 CFR part 11 and its importance.

Course Curriculum

  • 11 chapters
  • 84 lectures
  • 10 quizzes
  • 1 Hour 30 Min total length
Toggle all chapters
1 Important Guidance and Articles
15 Min

2 SOP for student
15 Min

1 Regulatory Affairs Profession, role and its importance, overview of worldwide Regulatory agencies
N/A

2 OVERVIEW OF WORLDWIDE REGULATORY AGENCIES
15 Min

3 Regulatory bodies across the world and different markets and brief introduction of registration process video 1
15 Min

4 Regulatory bodies across the world and different markets and brief introduction of registration process video 2
15 Min

5 Role & Responsibilities of RA
15 Min

6 PPT- GMP Lecture by Arvind Kadam
15 Min

7 GMP Lecture by Arvind Kadam Video-1
15 Min

8 GMP Lecture by Arvind Kadam Video-2
15 Min

9 GMP Lecture by Arvind Kadam Video-3
15 Min

10 MCQs 1 [Quiz]
5 Min

1 API Characterization and Polymerization
15 Min

2 Polymorphism
15 Min

3 guidelines for residual solvents
15 Min

4 Guidance development and manufacturing of drug substance
15 Min

5 Guidance for Analytical method and impurities - 1
15 Min

6 Guidance for Analytical method and impurities - 2
15 Min

7 Article
15 Min

8 ICH Guidance by Arvind Kadam
15 Min

9 ICH Guidance Arvind Kadam Lecture Video 1
15 Min

10 ICH Guidance Arvind Kadam Lecture Video 2
15 Min

11 ICH Guidance Arvind Kadam Lecture Video 3
15 Min

12 Analytical Validation Lecture By Arvind Kadam Video -1
15 Min

13 Analytical Validation Lecture By Arvind Kadam Video -2
15 Min

14 Analytical Validation Lecture By Arvind Kadam Video -3
15 Min

15 Analytical Validation Lecture By Arvind Kadam Video -4
14 Min

16 Analytical Validation PPT-Arvind Kadam
15 Min

17 MCQs 2 [Quiz]
5 Min

1 DMF
15 Min

2 Guidelines for drug master files
15 Min

3 DMF By Rajni Jha Video-1
15 Min

4 DMF By Rajni Jha Video-2
15 Min

5 DMF By Rajni Jha Video-3
15 Min

6 DMF By Rajni Jha Video-4
15 Min

7 PPT
15 Min

8 MCQs 3 [Quiz]
5 Min

1 ASMF
15 Min

2 Guidances-1
15 Min

3 Guidances-2
15 Min

4 PPT
15 Min

5 Marketing authorization EU video
15 Min

6 MCQs 4 [Quiz]
5 Min

1 DMF in CTD format
15 Min

2 CTD Module- 3S part-Drug Substance
15 Min

3 PPT
15 Min

4 DMF submissions video - 1
15 Min

5 DMF submissions video - 2
15 Min

6 DMF submissions video - 3
15 Min

7 DMF submissions video - 4
15 Min

8 CMC Writing in Detail video-1
15 Min

9 CMC Writing in Detail video-2
15 Min

10 MCQs 5 [Quiz]
5 Min

1 Procedure of filling in European country (related to DMF)
15 Min

2 Guidance - 1
15 Min

3 Guidance - 2
15 Min

4 PPT
15 Min

5 Marketing Authorization in EU video
15 Min

6 Quiz 6 [Quiz]
5 Min

1 Certificate of Suitability
15 Min

2 CEP guidance
15 Min

3 Quiz 7 [Quiz]
5 Min

1 Regulatory filing of API in Canada, Australia and Japan
15 Min

2 Article - 1
15 Min

3 Article - 2
15 Min

4 Quiz 8 [Quiz]
5 Min

1 21 CFR Part II
15 Min

2 21 CFR Part 11 video
15 Min

3 Guidance - 1
15 Min

4 Guidance - 2
15 Min

5 PPT
15 Min

6 Data integrity video 1
15 Min

7 Data integrity video 2
15 Min

8 Data integrity video 3
15 Min

9 Data integrity video 4
15 Min

10 Data integrity video 5
15 Min

11 Organization of CTD video 1
15 Min

12 Organization of CTD video 2
15 Min

13 Organization of CTD video 3
15 Min

14 Basic CMC and Scientific and Regulatory Writing Skills video 1
15 Min

15 Basic CMC and Scientific and Regulatory Writing Skills video 2
15 Min

16 Basic CMC and Scientific and Regulatory Writing Skills video 3
15 Min

17 Quiz 9 [Quiz]
5 Min

1 MCQ EXAM [Quiz]
1 Hour 40 Min

Instructor

Rajashri Ojha

0 Rating
0 Reviews
33 Students
155 Courses

Course Full Rating

0

Course Rating
(0)
(0)
(0)
(0)
(0)

No Review found

Sign In or Sign Up as student to post a review

Student Feedback

Course you might like

Short Courses
Dossier preparation in CTD/eCTD format
0 (0 Rating)
0 Students
3,499.00 ₹ 4,200.00 ₹
Regular Courses
Effective CMC Writing & Review Skill For DS & DP
0 (0 Rating)
1 Students
This course will cover Basics of CMCs, effective technical CMC Writing skills, CTD Module 3-Quality Overall Summary,  Pu...
7,499.00 ₹ 9,000.00 ₹

You must be enrolled to ask a question

Students also bought

Advance Course in Global Regulatory Affairs [GRA]
Regular Courses
  • 363 Lectures
  • 10 Min
  • 0 (0 Rating)
  • 6 Students
  • 24,999.00 ₹
  • 30,000.00 ₹
Test Webinar 3
Short Courses
  • 0 Lectures
  • N/A
  • 0 (0 Rating)
  • 2 Students
  • Free
new webinaar
Short Courses
  • 0 Lectures
  • N/A
  • 0 (0 Rating)
  • 1 Students
  • Free
Clinical Research [CR]
Regular Courses
  • 50 Lectures
  • 10 Min
  • 0 (0 Rating)
  • 2 Students
  • 9,999.00 ₹
  • 12,000.00 ₹
  • 0 (0 Rating)
  • 1 Students
  • 24,999.00 ₹
  • 30,000.00 ₹
Medical Device Regulation in India
Short Courses
  • 20 Lectures
  • 3 Hours
  • 0 (0 Rating)
  • 2 Students
  • 3,499.00 ₹
  • 4,200.00 ₹

9,999.00 ₹

12,000.00 ₹

Add To Cart Buy Now

  • Duration 1 Hour 30 Min

  • Lectures 84 lessons

  • Enrolled 0 students

  • Category: Pharmaceuticals

  • 10 Quizzes

  • Language: English

  • Skill Level Regular Courses

  • Certificate of Completion

  • 90 Days Access

Remove Coupon
Coupon Applied!

More Courses by Author

Discover Additional Learning Opportunities

View All
Short Courses
Biosimilars test and quiz
0 (0 Ratings)
1 Students
Introduction in BiologicsHistory of BiologicsAdvancing Biomedical ScienceComparison of development a...
7,499.00 ₹ 9,000.00 ₹
Short Courses
MDD to MDR Implementation 2
0 (0 Ratings)
0 Students
This module will cover Difference and similarities between MDD and MDR, MDR Transition period, key a...
7,499.00 ₹ 8,999.00 ₹
Regular Courses
Effective CMC Writing & Review Skill For DS & DP
0 (0 Ratings)
1 Students
This course will cover Basics of CMCs, effective technical CMC Writing skills, CTD Module 3-Quality...
7,499.00 ₹ 9,000.00 ₹
Short Courses
Drug Regulatory System In Us
0 (0 Ratings)
2 Students
This course covers History of FDA and Related Regulatory Agencies, FDA & CDER – Organization and res...
3,499.00 ₹ 4,200.00 ₹
Short Courses
Drug Regulation in Europe
0 (0 Ratings)
0 Students
This course will cover Pharmaceuticals in the European Union, History of Drug Regulation in European...
3,499.00 ₹ 4,200.00 ₹
Short Courses
ICH Q2 [Analytical validations]
0 (0 Ratings)
1 Students
This module will cover analytical method validation procedure and its importance, ICH Q 2 guidance
3,499.00 ₹ 4,200.00 ₹

Shopping Cart

Loading...