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 |
|
|
Learning objectives |
|
|
Who should take this course? |
|
|
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 |
|
|
Quality Control |
|
|
Sampling |
|
|
Documentation |
|
|
Stability Programme |
|
|
Quality Testing |
|
|
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.
Call us on
