Udemy - Good Manufacturing Practice (GMP) Essentials for Success

  • Category Other
  • Type Tutorials
  • Language English
  • Total size 1,020.3 MB
  • Uploaded By freecoursewb
  • Downloads 104
  • Last checked 1 month ago
  • Date uploaded 1 month ago
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Infohash : 6FEDCC5CA43DBB702997AA18D08913F5EBAE7E5E



Good Manufacturing Practice (GMP) Essentials for Success

https://WebToolTip.com

Published 12/2025
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 2h 20m | Size: 1 GB

Mastering GMP: Quality Systems, Risk Management and Inspection Readiness. From Fundamentals to Implementation.

What you'll learn
The fundamental purpose and importance of Good Manufacturing Practices (GMP)
Core GMP principles and global regulatory expectations (FDA, WHO, EU, ICH)
Structure and function of a pharmaceutical quality system
Differences between Quality Assurance (QA) and Quality Control (QC)
Good Documentation Practices (GDP) and the ALCOA+ data integrity framework
Roles, responsibilities, and competency requirements for GMP personnel
How training, hygiene, and professional behavior impact product quality
Key facility, cleanroom, HVAC, and equipment requirements under GMP
Production operations, material handling, traceability, and distribution controls
Principles of process validation and cleaning validation
Strategies to prevent contamination, along with cleaning and sanitation programs
Environmental monitoring methods and how to interpret trends
Quality Risk Management tools and how to perform risk assessments
Deviation handling, root cause analysis, and effective CAPA implementation
How to prepare for and participate in internal audits and regulatory inspections

Requirements
A willingness to learn and develop professional skills in regulated industries

Files:

[ WebToolTip.com ] Udemy - Good Manufacturing Practice (GMP) Essentials for Success
  • Get Bonus Downloads Here.url (0.2 KB)
  • ~Get Your Files Here ! 1-GMP Foundations
    • 1-Introduction to GMP and Its Importance.mp4 (16.9 MB)
    • 2-Core Principles and Objectives of GMP.mp4 (27.1 MB)
    • 3-Global Regulatory Bodies and GMP Standards (FDA, WHO, EU, ICH).mp4 (65.0 MB)
    2-Quality System Essentials
    • 1-Quality Assurance vs Quality Control.mp4 (16.4 MB)
    • 2-Documentation Requirements and Good Documentation Practices (GDP).mp4 (43.0 MB)
    • 3-Data Integrity and ALCOA+ Principles.mp4 (60.2 MB)
    3-Personnel & Training
    • 1-Roles, Responsibilities, and Competency Requirements.mp4 (72.8 MB)
    • 2-Training Programs and Ongoing Qualification.mp4 (30.3 MB)
    • 3-Personal Hygiene, Behavior, and GMP Mindset.mp4 (29.4 MB)
    4-Facilities, Equipment & Environment
    • 1-Facility Layout and GMP Facility Requirements.mp4 (22.2 MB)
    • 2-Cleanrooms, Environmental Classes, and HVAC Systems.mp4 (35.7 MB)
    • 3-Equipment Qualification, Calibration, and Maintenance.mp4 (43.6 MB)
    5-Production & Process Control
    • 1-Overview of Production Operations Under GMP.mp4 (32.6 MB)
    • 2-Material Handling, Storage, and Traceability.mp4 (61.1 MB)
    • 3-Process Validation and Cleaning Validation.mp4 (44.5 MB)
    • 4-Labeling, Packaging, and Distribution Controls.mp4 (51.6 MB)
    6-Contamination Control
    • 1-Types of Contamination (Microbial, Particulate, Chemical).mp4 (25.8 MB)
    • 2-Cleaning, Sanitation, and Disinfection Programs.mp4 (61.1 MB)
    • 3-Environmental Monitoring and Trending.mp4 (49.7 MB)
    7-Risk & Investigation Management
    • 1-Quality Risk Management and Risk Assessment Tools.mp4 (36.0 MB)
    • 2-Deviation Management and Root Cause Analysis.mp4 (36.6 MB)
    • 3-CAPA (Corrective and Preventive Actions).mp4 (49.8 MB)
    8-Audits & Inspections
    • 1-Internal Audits and Self-Inspections.mp4 (49.6 MB)
    • 2-Regulatory Inspections and Compliance Expectations.mp4 (59.2 MB)
    • Bonus Resources.txt (0.1 KB)

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