Good Manufacturing Practices (cGMP)

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Description:

This accredited online training course will teach you about Good Manufacturing Practice (cGMP) which is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Curriculum for this course:

Introduction

Overview	45 secs
Learning objectives	1 min 01 secs
Who should take this course?	1 min 55 secs
Module overview	1 min 45 secs

Module 1: The Starting Line

Overview	1 min 30 secs
What is GMP?	1 min 12 secs
What is cGMP?	1 min 41 secs
World Health Organization (WHO)	1 min 34 secs
Why GMP?	56 secs

Module 2: Cases From History

Overview	1 min 35 secs
Cases from history	1 min 39 secs
1930 – Lubeck – BCG Vaccine	1 min 44 secs
1938 – Sulphanilamide	1 min 13 secs
1940 – Contaminated Caps – Lambert	1 min 01 secs
1955 – Polio Vaccine	1 min 19 secs
1962 – Thalidomide	32 secs
Why GMP is so Important?	1 min 18 secs

Module 3: GMP Regulations

Overview	14 secs
GMP Regulations & Guidelines	1 min 27 secs
GMP's in Different Countries	1 min 49 secs
WHO	1 min 50 secs
ICH	1 min 29 secs
EMEA	1 min 09 secs
MHRA	43 secs
USFDA	1 min 06 secs
GMP concept	1 min 07 secs
What aspects of manufacturing does cGMP cover?	30 secs
Review activity	5 mins

Module 4: Quality Management System (QMS)

Overview	1 min 11 secs
What is Quality Management?	1 min 56 secs
Standard Operating Procedures (SOP)	57 secs
Quality Objective	1 min 08 secs
GMP as a part of Quality Assurance	56 secs
Requirements for an effective QA program	41 secs
ICH Q10	1 min 54 secs
Life Cycle Phases of GMP	1 min 22 secs

Module 5: Premises

Overview	13 secs
Premises	1 min 35 secs
Production Areas	1 min 08 secs
Changing Rooms	1 min 50 secs
Storage Areas	46 secs
Quality Control Areas	1 min 19 secs

Module 6: Personnel

Overview	12 secs
Personnel	1 min 57 secs
General Principles	58 secs
Staff Product Contact Requirements	1 min 29 secs
Grades A,B,C & D	1 min 29 secs
Personal Hygiene	1 min 52 secs
General considerations for manufacturing areas	1 min 32 secs
Review activity	5 mins

Module 7: Changes to Equipment

Overview	16 secs
Equipment	1 min 57 secs
Balances	1 min 20 secs
Utilities	1 min 30 secs
Documentation	51 secs
Change control	1 min 51 secs

Module 8: Qualification & Validation

Overview	1 min 14 secs
Definitions	1 min 16 secs
Qualification Vs Validation	1 min 17 secs
Risk Assessment	1 min 16 secs
Types of Validation Documentation	1 min 27 secs

Module 9: Complaints and Product Recalls

Overview	30 secs
Complaints and product recalls	1 min 32 secs
Classification of defects – critical	1 min 20 secs
Classification of defects – major	1 min 54 secs
Classification of defects – minor	2 min 02 secs
Product recall procedures	1 min 21 secs

Module 10: Self-Inspection

Overview	11 secs
Self-inspection	35 secs
Frequency	40 secs
Self inspection team	38 secs
Self Inspection approach – systems	41 secs
Self inspection approach – areas	1 min 11 secs
Review activity	5 mins

Module 11: Production Practices

Overview	13 secs
Good Practices in Production	1 min 18 secs
Prevention of Cross Contamination	1 min 15 secs

Module 12: Quality Control

Overview	15 secs
Quality Control	1 min 22 secs
Sampling	49 secs
Documentation	46 secs
Stability Programme	29 secs
Quality Testing	58 secs
Moving forward	2 mins 05 secs