I thought it would be hard to find a good institute for this course. Thank God, Covalent did an excellent job by providing valuable training in Good Manufacturing Practice (GMP). I strongly suggest this institute.
Introduction
Overview |
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Learning objectives |
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Who should take this course? |
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Module overview |
Module 1: The Starting Line
Overview |
What is GMP? |
What is cGMP? |
World Health Organization (WHO) |
Why GMP? |
Module 2: Cases From History
Overview |
Cases from history |
1930 – Lubeck – BCG Vaccine |
1938 – Sulphanilamide |
1940 – Contaminated Caps – Lambert |
1955 – Polio Vaccine |
1962 – Thalidomide |
Why GMP is so Important? |
Module 3: GMP Regulations
Overview |
GMP Regulations & Guidelines |
GMP's in Different Countries |
WHO |
ICH |
EMEA |
MHRA |
USFDA |
GMP concept |
What aspects of manufacturing does cGMP cover? |
Review activity |
Module 4: Quality Management System (QMS)
Overview |
What is Quality Management? |
Standard Operating Procedures (SOP) |
Quality Objective |
GMP as a part of Quality Assurance |
Requirements for an effective QA program |
ICH Q10 |
Life Cycle Phases of GMP |
Module 5: Premises
Overview |
Premises |
Production Areas |
Changing Rooms |
Storage Areas |
Quality Control Areas |
Module 6: Personnel
Overview |
Personnel |
General Principles |
Staff Product Contact Requirements |
Grades A,B,C & D |
Personal Hygiene |
General considerations for manufacturing areas |
Review activity |
Module 7: Changes to Equipment
Overview |
Equipment |
Balances |
Utilities |
Documentation |
Change control |
Module 8: Qualification & Validation
Overview |
Definitions |
Qualification Vs Validation |
Risk Assessment |
Types of Validation Documentation |
Module 9: Complaints and Product Recalls
Overview |
Complaints and product recalls |
Classification of defects – critical |
Classification of defects – major |
Classification of defects – minor |
Product recall procedures |
Module 10: Self-Inspection
Overview |
Self-inspection |
Frequency |
Self inspection team |
Self Inspection approach – systems |
Self inspection approach – areas |
Review activity |
Module 11: Production Practices
Overview |
Good Practices in Production |
Prevention of Cross Contamination |
Module 12: Quality Control
Overview |
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Quality Control |
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Sampling |
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Documentation |
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Stability Programme |
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Quality Testing |
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Moving forward |
Realtime Projects or Practicals on:-
Quality Systems
Facilities and Equipment Systems
Materials Systems
Production Systems
Packaging and Labeling Systems
Laboratory Control Systems
Yes
If you miss a class we can provide recording video for particular session or we can arrange you the back up session.
Yes
Yes
Doubts clarification up to getting a job
Resume preparation
Malk interviews
Placement Assistance
Class Room & Online Live sessions
Real-time projects
Working faculties
Placement assistance
Resume preparation
Doubts Clarifications
Covalent provides training certificate after completion of the course.
I thought it would be hard to find a good institute for this course. Thank God, Covalent did an excellent job by providing valuable training in Good Manufacturing Practice (GMP). I strongly suggest this institute.
Excellent realtime training on GMP. I got a very clear understanding and confidence after the course, I strongly recommend Covalent Trainings.
I am very glad to be a part of this institute...such an encouraging and helpful to getting jobs always...Thanks a lot for everything.
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