Good Manufacturing Practices (GMP) & GMP AUDITS

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Aydan Ozden

4:17:45

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1. Introduction

1.1 1 Introductıon.pdf

1. Introduction.mp4

03:58

2. GMP GMP Audits

1.1 2 1 GMP AUDITS.pdf

1. GMP GMP Audits.mp4

08:35

3. Quality System

1.1 3 1 GMP.pdf

1. Good Manufacturing Practices (GMP).mp4

14:43

2.1 3 2 GMP REQ.pdf

2. Basic Requirements of Good Manufacturing Practices (GMP).mp4

23:47

3.1 3 3 PQS.pdf

3. Pharmaceutical Quality System.mp4

16:34

4. Personnel

1.1 4 1 PERSONNEL.pdf

1. Personnel in GMP.mp4

09:17

2.1 4 2 PERSONNEL HYGIENE.pdf

2. Personnel Hygiene.mp4

12:08

5. Premises and Equipments

1.1 5 1 PE GeneralInformation.pdf

1.Premises and Equipments General Information.mp4

07:34

2.1 5 2 PE ManufacturingArea.pdf

2.Premises and Equipments in Manufacturing Area.mp4

15:53

3.1 5 3 PE StorageArea.pptx

3.Premises and Equipments in Storage Area.mp4

09:20

4.1 5 4 PE QualityControl.pdf

4.Premises and Equipments in Quality Control.mp4

04:37

5.1 5 5 PE Equipment.pdf

5.Equipment Requirements.mp4

05:18

6. Documentation

1.1 6 1 D GeneralInformation.pdf

1. Documentation.mp4

15:33

2.1 6 2 D Specifications.pdf

2. Specifications.mp4

04:24

3.1 6 3 D ManufacturingDocumentation.pdf

3. Batch Manufacturing Record (BMR).mp4

07:28

7. Production

1.1 7 1 P GeneralInformation.pdf

1. Production.mp4

15:15

2.1 7 2 P Contamination Cross Mixup.pdf

2. Contamination, Cross-Contamination and Mix-up.mp4

04:41

3.1 7 3 P Contamination.pdf

3. Cross-contamination.mp4

12:08

8. Quality Control

1.1 8 1 QC GeneralInformation.pdf

1. Quality Control Laboratory.mp4

07:38

2.1 8 2 QC GLP.pdf

2. Good Laboratory Practices.mp4

10:12

9. Quality Assurance

1.1 9 1 QA ProductQualityReview.pdf

1. Product Quality Review (PQR).mp4

06:07

2.1 9 2 QA Complaints.pdf

2. Complaints.mp4

02:26

3. Change Management.mp4

09:29

4. Deviation.mp4

15:19

5.1 9 5 QA CAPA.pdf

5. Corrective Action and Preventive Action (CAPA).mp4

07:47

10. Conclusion

1.1 CONCLUSION AYDANOZDEN.pdf

1. Conclusion.mp4

07:34

Description

Explore Good Manufacturing Practices (GMP) and practice 250 audit questionare for full confidence !

What You'll Learn?

Understand and define main principles of Good Manufacturing Practices (GMP)
Explore and define audit approach in GMP systems
Explore and understand audit type/process in GMP systems
Understand audit approaches and investigate audit question types
Define general scope of quality management/quality assurance in pharmaceutical industry
Understand and define main principles of Good Laboratary Practices (GLP)
Understand and define main principles of Good Hygiene Practices (GHP)
Understand and define main principles of Good Documentation Practices (GDP)

Who is this for?

Learners who desire to take a part in Pharmaceutical Industry

Anyone who is looking to learn quality and audit approaches in pharmaceutical industry

Anyone who interest GMP certification 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 pharma professional

More details

Description
Good Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.
GMP Audit refers to regular visits to evaluate facilities, production and ensure that all activities are in line with current good manufacturing practices (cGMP).
Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.

COURSE AGENDA
1 Introduction to GMP & GMP AUDITS
2 General Information about GMP Audits
3 Quality System
3.1. Good Manufacturing Practices (GMPs)
3.2. Basic Requirements of Good Manufacturing Practices (GMPs)
3.3. Pharmaceutical Quality System
4 Personnel
4.1. Personnel
4.2. Personnel & Hygiene
5 Premises & Equipments
5.1. General Information about Premises & Equipments
5.2. Premises & Equipments Requirements in Manufacturing Area
5.3. Premises & Equipments Requirements in Storage Area
5.4. Premises & Equipments Requirements in Quality Control
5.5. Equipment
6 Documentation
6.1. General Information about Documentation
6.2. Specification
6.3. Manufacturing Documentation
7 Production
7.1. General Information about Production
7.2. Contamination, Cross Contamination, Mix-up
7.3. Cross-Contamination
8 Quality Control
8.1. General Information
8.2. Good Laboratory Practices
9 Quality Assurance
9.1. Product Quality Review (PQR)
9.2. Complaints
9.3. Change Management
9.4. Deviation
9.5. Corrective Action & Preventive Action
10 Additional Audit Questionare
11 Conclusion
Who this course is for:
Learners who desire to take a part in Pharmaceutical Industry
Anyone who is looking to learn quality and audit approaches in pharmaceutical industry
Anyone who interest GMP certification 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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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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