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Course Overview
Schedule of Classes
Course Curriculum
1 Subject
SDP_Good Manufacturing Practices
102 Learning Materials
Week 1
Session Planner
PDF
Anagram_GMP
PDF
Introduction to GMP: 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
Case Study : GMP & Regulations
PDF
Week 2
Student Reading Material
PDF
Student Content : Summary Document
PDF
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
Assessment
External Link
Feedback form
External Link
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
Case Study : Pharma Functions
PDF
Assessment
External Link
Feedback form
External Link
Week 4
Anagram
PDF
Documentation Practices – Batch Records & Validation Procedures
PDF
Data Integrity Assurance – ALCOA, Audit Trails
PDF
Self-Inspection & Audit Methodology + Mock Internal Audit
PDF
Course Content Summary Document
PDF
INTRODUCTION VIDEO 1: Why Documentation Matters in Pharma
Video
00:00:53
? INTRODUCTION VIDEO 2: Understanding Batch Records
Video
00:01:22
? INTRODUCTION VIDEO 3: What is Data Integrity?
Video
00:01:22
? INTRODUCTION VIDEO 4: Common Pitfalls in Pharma Documentation
Video
00:01:22
Video Introduction Summary
PDF
Activity 1
PDF
? EXPLAINER VIDEO 1: Inside the BMR: What Goes In
Video
00:02:41
? EXPLAINER VIDEO 2: Creating a Mock Batch Record
Video
00:02:35
? EXPLAINER VIDEO 3: ALCOA+ Explained with Real Examples
Video
00:02:25
EXPLAINER VIDEO 4: Deviation Management & Audit Trails
Video
00:02:25
Activity 2
PDF
Video Explainer Summary
PDF
Case Study : Documentation
PDF
Case Study: Internal Audits
PDF
Assessment
External Link
Week 5
Anagram
PDF
Qualification & Validation – URS, IQ, OQ, PQ Protocols
PDF
Live Case Discussion on Equipment Validation Failures
PDF
Change Control – Processes and Technical Change Management
PDF
"Deviation Management – Unplanned vs Planned Deviation + CAPA "
PDF
Course Content Summary Document
PDF
Introduction Video – “The Journey of a Machine”
Video
00:01:38
Introduction Video 2: Change Control Processes & Technical Change Management
Video
00:01:38
Introduction Video 3 – “When Things Go Off Track”
Video
00:01:38
Video Summary Document
PDF
Explainer Video 1 – “ Validating for Patient Safety”
Video
00:02:45
Explainer Video 2 – “How to Control Change Without Chaos”
Video
00:02:45
Explainer Video 3 – “Deviation to Improvement: A CAPA Story”
Video
00:02:45
Activity
PDF
Activity Trainer Reference document
PDF
Case Study : Qualification and Validation
PDF
Case Study : Change Control
PDF
Case Study: Deviation Management
PDF
Week 6
Out of Specification (OOS)
PDF
Root-Cause-Analysis-in-Pharmaceutical-Manufacturing
PDF
-Corrective-and-Preventive-Actions-CAPA-for-Microbiological-Contamination
PDF
Content Summary Document
PDF
Video Summary Document
PDF
Activity
PDF
Case Study : OOS
PDF
Case Study:RCA_CAPA
PDF
Anagram
PDF
Week 7
Week 8
QRM – Introduction and Process Flow per ICH Q9
PDF
Market Return & Retention Sample Management + Use Case
PDF
Market Return & Retention Sample
PDF
Case Study: Market Returns
PDF
Week 9
Complaint Handling and Product Recall + Recall Classification
PDF
Course Content Summary Document
PDF
Case Study : Complaint & product Recall
PDF
Course Instructor
Sandhya
27 Courses • 10005 Students
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