Technical Project Management for Generic Drug Development

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Aydan Ozden

5:37:05

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1 - Introduction

1 - 1-Introduct-on.pdf

1 - Introduction.mp4

09:04

2 - Introduction to Generic Drug Development

2 - 2-1-PM.pdf

2 - Active Pharmaceutical Ingredient API Finished Pharmaceutical Product FPP.mp4

06:14

3 - 2-2-PM.pdf

3 - Reference Listed Drug RLD Generic Multisource Pharmaceutical Products.mp4

15:45

4 - 2-3-PM.pdf

4 - Pharmaceutical Bioequivalency Therapeutic Equivalency.mp4

05:06

5 - 2-4-PM.pdf

5 - Reference Listed Drug RLD Development.mp4

09:17

6 - 2-5-PM.pdf

6 - Generic Drug Development.mp4

03:44

7 - 2-6-PM.pdf

7 - Comparision of Reference Listed Drug RLD Development Generic Drug Developmen.mp4

12:01

8 - 2-7-PM.pdf

8 - Invitro Invivo Studies for Drug Product.mp4

05:50

3 - Introduction to Project Management

9 - 3-1-PM.pdf

9 - Project Elements of Project Cost Time Scope.mp4

06:12

10 - 3-2-PM.pdf

10 - Priorizitation of Project Pipeline.mp4

03:35

11 - 3-3-PM.pdf

11 - Project Phases.mp4

11:30

12 - 3-4-PM.pdf

12 - Project Manager.mp4

02:01

13 - Project Team Project Stakeholders.mp4

05:19

14 - 3-6-PM.pdf

14 - Project Management Tools.mp4

05:09

4 - Project Management for Generic Drug Development

15 - 4-1-PM.xlsx

15 - Project Diary for Generic Drug Development.mp4

03:05

16 - 4-2-PM.xlsx

16 - Project Milestones for Generic Drug Development.mp4

02:28

17 - 4-3-PM.xlsx

17 - Project Gantt Chart for Generic Drug Development.mp4

04:07

18 - 4-4-PM.xlsx

18 - Generic Drug Development Project Phases.mp4

02:24

5 - Desk Research for Generic Drug Development

19 - 5-1-PM-DeskResearch.pdf

19 - Desk Research for Generic Drug Development.mp4

05:04

20 - 5-2-PM-DeskResearch.pdf

20 - European Medicines Agency EMA.mp4

22:13

21 - 5-3-1.pdf

21 - 5-3-2.pdf

21 - 5-3-PM-DeskResearch.pdf

21 - World Health Organization WHO Food and Drug Administration FDA.mp4

16:48

22 - 5-4-PM-DeskResearch.pdf

22 - Pharmacopoeias Dailymed.mp4

08:34

23 - 5-5-PM-DeskResearch.pdf

23 - Drugscom.mp4

02:45

24 - 5-6-PM-DeskResearch.pdf

24 - DrugBank.mp4

06:59

25 - 5-7-1.pdf

25 - 5-7-PM-DeskResearch.pdf

25 - Google Patents.mp4

10:18

26 - 5-8-PM-DeskResearch.pdf

26 - Espacenet.mp4

06:07

6 - Raw Material Selection for Generic Drug Development

27 - 6-1-PM-RawMaterialSelection.pdf

27 - Raw Material Selection for Generic Drug Development.mp4

02:27

28 - 6-2-PM-RawMaterialSelection.pdf

28 - Evaluation of Characteristics of API.mp4

07:28

29 - 6-3-PM-RawMaterialSelection.pdf

29 - Stability Characteristics of API.mp4

04:05

30 - 6-4-PM-RawMaterialSelection.pdf

30 - Evaluation of Suppliers of API.mp4

05:27

31 - 6-5-PM-RawMaterialSelection.pdf

31 - Evaluation of Inactive Ingredient and Packaging Material.mp4

06:04

7 - PreFormulation Studies for Generic Drug Development

32 - 7-1-PM-PreFormulationStudies.pdf

32 - PreFormulation Studies for Generic Drug Development.mp4

02:11

33 - 7-2-PM-PreFormulationStudies.pdf

33 - Characterization of RLD.mp4

01:22

34 - 7-3-PM-PreFormulationStudies.pdf

34 - Defining Quality Target Product Profile QTPP.mp4

02:28

35 - 74.mp4

02:13

35 - Evaluation of BE Requirements.mp4

02:13

36 - 7-5-PM-PreFormulationStudies.pdf

36 - Evaluation of Inactive Ingredient Required for Formula.mp4

02:45

37 - 7-6-PM-PreFormulationStudies.pdf

37 - Compatibility Study.mp4

05:21

38 - 7-7-PM-PreFormulationStudies.pdf

38 - Supplying New material Apparatus Equipment.mp4

01:22

39 - 7-8-PM-PreFormulationStudies.pdf

39 - Performing PreFormulation Trials.mp4

03:14

8 - Analytical Method Development Studies for Generic Drug Development

40 - 8-1-PM-AMD-Studies.pdf

40 - Analytical Method Development Studies for Generic Drug Development 1.mp4

03:48

41 - 8-2-PM-AMD-Studies.pdf

41 - Analytical Method Development Studies for Generic Drug Development 2.mp4

01:01

42 - 8-3-PM-AMD-Studies.pdf

42 - Literature Search for Analytical Method Development.mp4

04:05

43 - 8-4-PM-AMD-Studies.pdf

43 - Supplying Chemicals Materials Equipments.mp4

02:02

44 - 8-5-PM-AMD-Studies.pdf

44 - Performing Method Development Studies.mp4

01:19

45 - 8-6-PM-AMD-Studies.pdf

45 - Determining Acceptance Criteria.mp4

03:42

46 - 8-7-PM-AMD-Studies.pdf

46 - Determining Dissolution Parameters.mp4

02:09

47 - 8-8-PM-AMD-Studies.pdf

47 - Performing Stress Studies.mp4

02:36

48 - 8-9-PM-AMD-Studies.pdf

48 - Performing PreValidation Studies.mp4

01:26

9 - Formulation Studies for Generic Drug Development

49 - 9-1-PM-FormulationforGDD.pdf

49 - Formulation Studies for Generic Drug Development.mp4

02:17

50 - 9-2-PM-FormulationforGDD.pdf

50 - Performing Formulation Trials.mp4

04:06

51 - 9-3-PM-FormulationforGDD.pdf

51 - Optimizing Formulation by using QBD.mp4

06:03

52 - 9-4-PM-FormulationforGDD.pdf

52 - Supplying Chemicals RawMaterials Equipments for Pilot Manufacturing.mp4

01:30

53 - 9-5-PM-FormulationforGDD.pdf

53 - Preparing Formulations for Critical Material Attributes CMA.mp4

07:11

54 - 9-6-PM-FormulationforGDD.pdf

54 - Preparing Formulations for Critical Quality Attribute CQA.mp4

03:21

55 - 9-7-PM-FormulationforGDD.pdf

55 - Preparing Formulations for Critical Process Parameter CPP.mp4

02:13

56 - 9-8-PM-FormulationforGDD.pdf

56 - Discriminitive Dissolution Parameters.mp4

05:53

57 - 9-9-PM-FormulationforGDD.pdf

57 - Compatibility Study with Final Formula Components.mp4

03:54

10 - Analytical Studies for Generic Drug Development

58 - 10-1-PM-AnalyticalStudies.pdf

58 - Analytical Studies for Generic Drug Development.mp4

06:28

11 - Pilot Manufacturing for Generic Drug Development

59 - Pilot Manufacturing for Generic Drug Development.mp4

08:00

12 - Analysis of Pilot Batches for Generic Drug Development

60 - 12-1-PM-AnalysisofPilotBatches.pdf

60 - Analysis of Pilot Batches for Generic Drug Development.mp4

04:31

13 - Performing Bioequivalency Study for Generic Drug Development

61 - 13-1-PM-BioequivalencyStudy.pdf

61 - Performing Bioequivalency Study for Generic Drug Development.mp4

07:33

14 - Preparation Registration Dossier for Generic Drug Development

62 - 14-1-PM-RegistrationDossier.pdf

62 - Preparation Registration Dossier for Generic Drug Development.mp4

04:04

15 - Conclusion

63 - CONCLUSION-AYDANOZDEN.pdf

63 - Conclusion.mp4

07:34

Description

Become a Technical Project Manager by Learning Generic Drug Development!

What You'll Learn?

Understand Project Management
Learn Generic Drug Development
Understand Desk Research for Generic Drug Development
Learn Raw Material Selection for Generic Drug Development
Learn Pre-Formulation Studies for Generic Drug Development
Understand Analytical Method Development Studies for Generic Drug Development
Discuss Formulation Studies for Generic Drug Development
Learn Pilot Manufacturing for Generic Drug Development
Understand Bioequivalency Study for Generic Drug Development
Learn Registration Dossier for Generic Drug Development

Who is this for?

Learners who desire to take a part in Pharmaceutical Industry

Existing pharma professionals who are looking to progress in their jobs

Anyone who is looking to get entry in pharmaceutical industry

What You Need to Know?

Require mobile/tablet/laptop/personal computer with internet

To be student, graduate and/or professional in related disciplines

More details

Description
COURSE CONTENT
1 Introduction
2 Introduction to Generic Drug Development
2.1. Active Pharmaceutical Ingredient (API) & Finished Pharmaceutical Product (FPP)
2.2. Reference Listed Drug (RLD) & Generic (Multisource) Pharmaceutical Products
2.3. Pharmaceutical Bioequivalency (Therapeutic Equivalency)
2.4. Reference Listed Drug (RLD) Development
2.5. Generic Drug Development
2.6. Comparision of Reference Listed Drug (RLD) Development & Generic Drug Development
2.7. In-vitro & In-vivo Studies for Drug Product
3 Introduction to Project Management
3.1. Project & Elements of Project (Cost, Time, Scope)
3.2. Priorizitation of Project (Pipeline)
3.3. Project Phases
3.4. Project Manager
3.5. Project Team & Project Stakeholders
3.6. Project Management Tools
4 Project Management for Generic Drug Development
4.1. Project Diary for Generic Drug Development
4.2. Project Milestones for Generic Drug Development
4.3. Project Gantt Chart for Generic Drug Development
4.4. Generic Drug Development Project Phases (Execution Phase)
5 Desk Research for Generic Drug Development
5.1. Desk Research for Generic Drug Development
5.2. European Medicines Agency (EMA)
5.3. World Health Organization (WHO) & Food and Drug Administration (FDA)
5.4. Pharmacopoeias & Dailymed
5.5. Drugscom
5.6. DrugBank
5.7. Google Patents
5.8. Espacenet
6 Raw Material Selection for Generic Drug Development
6.1. Raw Material Selection for Generic Drug Development
6.2. Evaluation of Characteristics of API
6.3. Evaluation of Stability Characteristics of API
6.4. Evaluation of Suppliers of API
6.5. Evaluation of Inactive Ingredient and Packaging Material
7 Pre-Formulation Studies for Generic Drug Development
7.1. Pre-Formulation Studies for Generic Drug Development
7.2. Characterization of RLD
7.3. Defining Quality Target Product Profile (QTPP)
7.4. Evaluation of BE Requirements
7.5. Evaluation of Inactive Ingredient Required for Formula
7.6. Compatibility Study
7.7. Supplying New material / Apparatus / Equipment
7.8. Performing Pre-Formulation Trials
8 Analytical Method Development Studies for Generic Drug Development
8.1. Analytical Method Development Studies for Generic Drug Development-1
8.2. Analytical Method Development Studies for Generic Drug Development-2
8.3. Literature Search for Analytical Method Development
8.4. Supplying Chemicals / Materials / Equipments
8.5. Performing Method Development Studies
8.6. Determining Acceptance Criteria
8.7. Determining Dissolution Parameters
8.8. Performing Stress Studies
8.9. Performing Pre-Validation Studies
9 Formulation Studies for Generic Drug Development
9.1. Formulation Studies for Generic Drug Development
9.2. Performing Formulation Trials
9.3. Optimizing Formulation by using QBD
9.4. Supplying Chemicals / Raw-Materials / Equipments for Pilot Manufacturing
9.5. Preparing Formulations for Critical Material Attributes (CMA)
9.6. Preparing Formulations for Critical Quality Attribute (CQA)
9.7. Preparing Formulations for Critical Process Parameter (CPP)
9.8. Discriminitive Dissolution Parameters
9.9. Compatibility Study with Final Formula / Components
10 Analytical Studies for Generic Drug Development
10.1. Validation of Analytical Methods
10.2. Evaluation Bulk and Product Characteristic / Performance
10.3. Comparision Test Product with RLD In-vitro Conditions
10.4. Performing Analysis of Formulations for Critical Material Attributes (CMA)
10.5. Performing Analysis of Formulations for Critical Quality Attribute (CQA)
10.6. Performing Analysis of Formulations for Critical Process Parameter (CPP)
10.7. Performing Analysis of Formulations for for Discrimitive Dissolution Parameters
10.8. Performing Analysis of Formulations for Compatibility Study with Final Formula / Components
11 Pilot Manufacturing for Generic Drug Development
11.1. Evaluation of Chemicals / Raw-materials / Equipments used for Pilot Manufacturing
11.2. Performing Risk Assesment for Pilot Manufacturing
11.3. Performing Quality Procedures for Pilot Manufacturing
11.4. Documentation for Pilot Manufacturing
11.5. Manufacturing of Pilot Batches
12 Analysis of Pilot Batches for Generic Drug Development
12.1. Analysis of Chemicals / Raw-Materials used for Pilot Manufacturing
12.2. Analysis of Pilot Batches
12.3. Comparision Pilot Batches with RLD in In-vitro Conditions
12.4. Determining of BE Batches
13 Performing Bioequivalency Study for Generic Drug Development
13.1. Preparing Documentation for In-vitro Test Results
13.2. Preparation of Samples for BE Studies
13.3. Performing BE Studies
13.4. Documentating of BE Results
14 Preparation Registration Dossier for Generic Drug Development
14.1. Preparation of Registration Dossier
14.2. Performing of Registration Application
15 Conclusion
Who this course is for:
Learners who desire to take a part in Pharmaceutical Industry
Existing pharma professionals who are looking to progress in their jobs
Anyone who is looking to get entry in pharmaceutical industry

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Project Management

Aydan Ozden

Instructor's Courses

She is Aydan OZDEN. She is working as R&D Formulation Development Scientist at Pharmaceutical Company. She hold a Bachelor of Chemistry and a Master’s degree in Organic Chemistry. She offer proficiency in pharmaceutical Quality and Research and Development including but not limited to drug formulation development, drug manufacturing process, and associated scientific and regulatory elements. She has an extensive knowledge in pharmaceutical R&D, specially in the drug formulation development, drug manufacturing process and associated scientific and regulatory elements with 9 years experience. She also gained strong theoretical and practical background in conducting preformulation studies, formulation development, process optimization and scale up of generic drug products while knowing and applying main principles of medicinal chemistry.She has five Udemy courses presented below.- Quality in Pharmaceutical Industry (GMP & GLP & GHP): This course is strongly recommended for learners who interest pharmaceutical industry and desire to take a part in Quality, Production, Technology Transfer and Research&Development Departments.- Pharmaceutical Dosage Forms & Basics of Pharma Industry: This course is strongly recommended for learners who interest pharmaceutical industry, especially for fresh graduate, and desire to take a part in Quality, Production, Technology Transfer, Research & Development Departments and Business Development.- Pharmaceutical Manufacturing & Technology (GRANULATION): This course is strongly recommended for learners who interest pharmaceutical drug manufacturing and desire to take a part in Quality Assurance, Production, Technology Transfer and Research & Development Departments.- Pharmaceutical Manufacturing & Technology (COATING): This course is strongly recommended for learners who interest pharmaceutical drug manufacturing and desire to take a part in Quality Assurance, Production, Technology Transfer and Research & Development Departments.- Preformulation Studies for Pharmaceutical Industry: This course is strongly recommended for learners who interest physicochemical properties of drug product and desire to take a part in Research & Development Department.- Preparation of Pharmaceutical Development Part for CTD: This course is strongly recommended for learners who interest pharmaceutical development / drug development and desire to take a part in Research & Development, Technology Transfer and Regulatory Affairs Departments.

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