SDP_Good Manufacturing Practices

Course Instructor: Sandhya

FREE

Course Overview

Schedule of Classes

Course Curriculum

1 Subject

SDP_Good Manufacturing Practices

56 Learning Materials

Resource Document 1:Introduction, GMP Guidelines, and Pharmaceutical Functions

Introduction

PDF

Functions of Pharmaceuticals

PDF

Week 1

Session Planner

PDF

Anagram_GMP

PDF

Introduction to GMP: Student Reading Material

PDF

Regulation & Compliance : Student Reading material

PDF

How to use Anagrams

PDF

A. Students to Think and Answer

What is GMP?

Video

00:02:07

B. Students to Think and Answer

Where GMP Applies in Industry

Video

00:02:01

C. Students to Think and Answer

How This Course Will Equip You

Video

00:02:08

D. Students to Think and Answer

Core Principles of GMP

Video

00:02:27

GMP Documentation & Data Integrity

Video

00:02:55

Validation in GMP

Video

00:02:36

Handling Deviations and Product Recalls

Video

00:02:21

Activity_GMP

PDF

Week 2

What is GMP and Why Does it Matter?

Video

00:00:53

Intro Video 1: Students to think and Answer

From Theory to Practice – GMP for Students

Video

00:01:02

Intro Video 2:Students to think and answer

Who Makes GMP Happen? Roles in Pharma

Video

00:00:55

Intro Video 3: Students to think and answer

Real Industry Challenges – And How GMP Solves Them

Video

00:01:01

Intro Video 4: Students to think and answer

Explainer video 1

Video

00:00:43

Explainer video 2

Video

00:00:35

Explainer video 3

Video

00:00:34

Explainer video 4

Video

00:00:34

Week 3

Functions of Pharmaceuticals

PDF

Content Summary Document

PDF

Intro video 1

Video

00:01:37

Intro video 2

Video

00:01:37

Video 3: Introduction to Regulatory Affairs (RA)

Video

00:01:58

Video 4: Introduction to Research & Development (R&D)

Video

00:01:39

Intro Video Summary Document

PDF

Explainer 1: QA Deep Dive

Video

00:02:29

Explainer 2: Production Line in Detail

Video

00:02:29

Explainer 3: Regulatory Affairs Lifecycle

Video

00:02:29

Explainer 4: R&D to Commercialization

Video

00:02:29

Explainer Summary Document

PDF

Week 4

Documentation Practices â€“ Batch Records & Validation Procedures

PDF

Data Integrity Assurance â€“ ALCOA, Audit Trails

PDF

Self-Inspection & Audit Methodology + Mock Internal Audit

PDF

Week 5

Qualification & Validation â€“ URS, IQ, OQ, PQ Protocols

PDF

Live Case Discussion on Equipment Validation Failures

PDF

Change Control â€“ Processes and Technical Change Management

PDF

Week 6

Deviation Management â€“ Unplanned vs Planned Deviation + CAPA

PDF

Out of Specification (OOS)

PDF

Week 7

Root Cause Analysis â€“ Tools like 5 Whys and Fishbone Diagram

PDF

Corrective and Preventive Actions â€“ CAPA Log & Effectiveness Check

PDF

Week 8

QRM â€“ Introduction and Process Flow per ICH Q9

PDF

Market Return & Retention Sample Management + Use Case

PDF

Week 9

Complaint Handling and Product Recall + Recall Classification

PDF

Course Instructor

Sandhya

27 Courses • 8826 Students

SDP_Good Manufacturing Practices

Course Overview

Schedule of Classes

Course Curriculum

SDP_Good Manufacturing Practices

Resource Document 1:Introduction, GMP Guidelines, and Pharmaceutical Functions

Introduction

Functions of Pharmaceuticals

Week 1

Session Planner

Anagram_GMP

Introduction to GMP: Student Reading Material

Regulation & Compliance : Student Reading material

How to use Anagrams

A. Students to Think and Answer

What is GMP?

B. Students to Think and Answer

Where GMP Applies in Industry

C. Students to Think and Answer

How This Course Will Equip You

D. Students to Think and Answer

Core Principles of GMP

GMP Documentation & Data Integrity

Validation in GMP

Handling Deviations and Product Recalls

Activity_GMP

Week 2

What is GMP and Why Does it Matter?

Intro Video 1: Students to think and Answer

From Theory to Practice – GMP for Students

Intro Video 2:Students to think and answer

Who Makes GMP Happen? Roles in Pharma

Intro Video 3: Students to think and answer

Real Industry Challenges – And How GMP Solves Them

Intro Video 4: Students to think and answer

Explainer video 1

Explainer video 2

Explainer video 3

Explainer video 4

Week 3

Functions of Pharmaceuticals

Content Summary Document

Intro video 1

Intro video 2

Video 3: Introduction to Regulatory Affairs (RA)

Video 4: Introduction to Research & Development (R&D)

Intro Video Summary Document

Explainer 1: QA Deep Dive

Explainer 2: Production Line in Detail

Explainer 3: Regulatory Affairs Lifecycle

Explainer 4: R&D to Commercialization

Explainer Summary Document

Week 4

Documentation Practices â€“ Batch Records & Validation Procedures

Data Integrity Assurance â€“ ALCOA, Audit Trails

Self-Inspection & Audit Methodology + Mock Internal Audit

Week 5

Qualification & Validation â€“ URS, IQ, OQ, PQ Protocols

Live Case Discussion on Equipment Validation Failures

Change Control â€“ Processes and Technical Change Management

Week 6

Deviation Management â€“ Unplanned vs Planned Deviation + CAPA

Out of Specification (OOS)

Week 7

Root Cause Analysis â€“ Tools like 5 Whys and Fishbone Diagram

Corrective and Preventive Actions â€“ CAPA Log & Effectiveness Check

Week 8

QRM â€“ Introduction and Process Flow per ICH Q9

Market Return & Retention Sample Management + Use Case

Week 9

Complaint Handling and Product Recall + Recall Classification

Course Instructor

Sandhya

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