Skip to main content
Good Manufacturing Practice (GMP) Fundamentals; A Step-by-Step Guide

Good Manufacturing Practice (GMP) Fundamentals; A Step-by-Step Guide

$199.00
When you get access:
Course access is prepared after purchase and delivered via email
How you learn:
Self-paced • Lifetime updates
Your guarantee:
30-day money-back guarantee — no questions asked
Who trusts this:
Trusted by professionals in 160+ countries
Toolkit Included:
Includes a practical, ready-to-use toolkit with implementation templates, worksheets, checklists, and decision-support materials so you can apply what you learn immediately - no additional setup required.
Adding to cart… The item has been added

Good Manufacturing Practice (GMP) Fundamentals: A Step-by-Step Guide



Course Overview

This comprehensive course provides a detailed understanding of Good Manufacturing Practice (GMP) principles and guidelines. Participants will learn the fundamentals of GMP and how to apply them in a real-world setting. Upon completion of the course, participants will receive a certificate issued by The Art of Service.



Course Features

  • Interactive and engaging learning experience
  • Comprehensive and up-to-date content
  • Personalized learning approach
  • Practical and real-world applications
  • High-quality content developed by expert instructors
  • Certificate issued by The Art of Service upon completion
  • Flexible learning schedule
  • User-friendly and mobile-accessible platform
  • Community-driven discussion forums
  • Actionable insights and hands-on projects
  • Bite-sized lessons for easy learning
  • Lifetime access to course materials
  • Gamification and progress tracking features


Course Outline

Module 1: Introduction to GMP

  • Definition and history of GMP
  • Importance of GMP in the pharmaceutical industry
  • Overview of GMP guidelines and regulations
  • Roles and responsibilities of GMP personnel

Module 2: GMP Principles and Guidelines

  • Quality management and quality control
  • Personnel and training requirements
  • Premises and equipment requirements
  • Material control and procurement
  • Manufacturing and packaging operations
  • Labeling and packaging control
  • Distribution and shipping

Module 3: GMP Documentation and Record-Keeping

  • Types of GMP documents and records
  • Document control and management
  • Record-keeping requirements and procedures
  • Electronic record-keeping systems
  • Data integrity and security

Module 4: GMP Audits and Inspections

  • Types of GMP audits and inspections
  • Audit and inspection procedures
  • Audit and inspection checklists
  • Corrective and preventive actions (CAPA)
  • Audit and inspection follow-up and closure

Module 5: GMP Training and Awareness

  • GMP training requirements and procedures
  • Training methods and materials
  • Training evaluation and assessment
  • GMP awareness and promotion
  • Continuous training and professional development

Module 6: GMP Continuous Improvement and Quality Management

  • Continuous improvement principles and methods
  • Quality management systems and models
  • Process improvement and optimization
  • Change management and control
  • Performance metrics and monitoring

Module 7: GMP Risk Management and Compliance

  • Risk management principles and methods
  • GMP risk assessment and mitigation
  • Compliance with GMP regulations and guidelines
  • Regulatory inspections and enforcement
  • Compliance monitoring and reporting

Module 8: GMP Supply Chain Management

  • Supply chain management principles and methods
  • GMP supplier selection and qualification
  • Supplier audit and inspection
  • Supply chain risk management and mitigation
  • Supply chain visibility and transparency

Module 9: GMP Product Life Cycle Management

  • Product life cycle management principles and methods
  • GMP product development and commercialization
  • Product quality and safety
  • Product labeling and packaging
  • Product distribution and shipping

Module 10: GMP Technology and Innovation

  • Emerging technologies and innovations in GMP
  • GMP automation and digitalization
  • Data analytics and artificial intelligence
  • Cloud computing and cybersecurity
  • Regulatory compliance and technology


Certificate and Assessment

Upon completion of the course, participants will receive a certificate issued by The Art of Service. The course assessment will include quizzes, assignments, and a final exam to ensure participants have a thorough understanding of GMP principles and guidelines.



Target Audience

This course is designed for professionals working in the pharmaceutical industry, including:

  • Quality assurance and quality control personnel
  • Manufacturing and production personnel
  • Regulatory affairs personnel
  • Supply chain management personnel
  • Product development and commercialization personnel


Duration and Format

The course is self-paced and can be completed in 12 weeks. The course materials include video lectures, readings, quizzes, assignments, and a final exam. Participants will have lifetime access to the course materials.

,
!