Complete Guide To Gmp In Pharma: From Basics To Advanced

Basics to Advance Compliance Pharma Regulatory Affairs GMP

What you'll learn

Understand GMP Fundamentals: Learners will gain a comprehensive understanding of Good Manufacturing Practices (GMP)

Regulatory Compliance: Learn to interpret and apply global GMP guidelines like WHO, FDA 21 CFR, and Schedule M for compliance.

Quality Control: Implement quality measures and manage risks, including warehouse management and handling non-compliance.

Advanced GMP: Master advanced GMP concepts like QbD, ALCOA, and pharma industry hierarchy for maintaining high compliance standards.

Requirements

Basic Pharma Knowledge, Interest in GMP, no special tools required, open to all

Description

Unlock the secrets to pharmaceutical excellence with our comprehensive course on Good Manufacturing Practices (GMP). This course is meticulously designed for professionals, students, and anyone interested in the pharmaceutical industry, covering everything from fundamental concepts to advanced compliance strategies.You will explore essential GMP guidelines, Quality by Design (QbD) principles, and key quality measures that are critical to successful pharmaceutical manufacturing. Dive deep into the frameworks of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) and Data Integrity, which are vital for maintaining high standards of quality and compliance.Through engaging lectures, real-world examples, and practical assignments, you’ll gain the knowledge and skills necessary to ensure product quality, meet regulatory requirements, and prioritize patient safety in the pharmaceutical sector.By the end of this course, you will have a thorough understanding of GMP principles and their application in various contexts. This knowledge will empower you to contribute effectively to your organization’s compliance efforts and enhance your professional profile.Join us today and elevate your expertise in GMP, paving the way for a successful and rewarding career in the pharmaceutical industry! Take the first step toward becoming a valuable asset in this vital field and make a significant impact on health and safety.

Overview

Section 1: Introduction

Lecture 1 Introduction

Lecture 2 Modules: Course Details

Section 2: GMP Basics and Regulations and Practices

Lecture 3 What is GMP

Lecture 4 GMP Regulation and Practices

Lecture 5 GMP Guidelines

Section 3: Structure and Quality

Lecture 6 Structure and Location

Lecture 7 Documentation and Pharma Quality System

Lecture 8 FDA 21CFR 210 Guideline

Lecture 9 WHO Guideline

Lecture 10 CDSCO

Lecture 11 Warehouse Quality System

Lecture 12 Risk of Not Following GMP

Lecture 13 Quality Measures in GMP

Section 4: Additional Lectures

Lecture 14 Hierarchy in Pharma Industry

Lecture 15 QbD (Quality by Design)

Lecture 16 ALCOA and DI

Lecture 17 Case Studies

pharma professionals, students and graduates, beginners, regulatory affair professionals, consultant, anyone interested in GMP