Published 9/2024
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz
Language: English | Size: 1.73 GB | Duration: 1h 57m
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
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