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Mastering Good Manufacturing Practice (GMP); A Step-by-Step Guide to Ensuring Compliance and Minimizing Risk

Mastering Good Manufacturing Practice (GMP); A Step-by-Step Guide to Ensuring Compliance and Minimizing Risk

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Mastering Good Manufacturing Practice (GMP): A Step-by-Step Guide to Ensuring Compliance and Minimizing Risk



Course Overview

This comprehensive course provides a step-by-step guide to Good Manufacturing Practice (GMP) compliance, ensuring that participants have the knowledge and skills needed to minimize risk and ensure the quality of pharmaceutical products. Upon completion, 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 experience
  • Practical and real-world applications
  • High-quality content developed by expert instructors
  • Certificate issued upon completion
  • Flexible learning options
  • User-friendly and mobile-accessible platform
  • Community-driven learning environment
  • 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 importance of GMP
  • History and evolution of GMP
  • Regulatory framework for GMP
  • Benefits of GMP implementation

Module 2: GMP Principles and Guidelines

  • Quality management principles
  • Personnel and training requirements
  • Premises and equipment requirements
  • Material control and procurement
  • Production and process control
  • Quality control and assurance
  • Documentation and record-keeping

Module 3: GMP Compliance and Auditing

  • Compliance with GMP regulations
  • Auditing and inspection requirements
  • Audit types and procedures
  • Audit tools and techniques
  • Corrective and preventive action (CAPA)

Module 4: Risk Management and Minimization

  • Risk management principles and guidelines
  • Risk assessment and analysis
  • Risk mitigation and control
  • Contingency planning and emergency preparedness

Module 5: Quality Management Systems (QMS)

  • QMS principles and guidelines
  • QMS documentation and record-keeping
  • QMS auditing and inspection
  • QMS continuous improvement and monitoring

Module 6: Supply Chain Management and GMP

  • Supply chain management principles and guidelines
  • Supplier selection and qualification
  • Supply chain risk management and mitigation
  • Supply chain auditing and inspection

Module 7: GMP in Practice: Case Studies and Examples

  • Real-world examples of GMP implementation
  • Case studies of GMP compliance and auditing
  • Lessons learned and best practices

Module 8: GMP and Regulatory Requirements

  • Regulatory requirements for GMP
  • GMP and FDA regulations
  • GMP and EU regulations
  • GMP and other international regulations

Module 9: GMP and Quality by Design (QbD)

  • QbD principles and guidelines
  • QbD and GMP
  • QbD and risk management
  • QbD and continuous improvement

Module 10: GMP and Data Integrity

  • Data integrity principles and guidelines
  • Data integrity and GMP
  • Data integrity and risk management
  • Data integrity and continuous improvement

Module 11: GMP and Computerized Systems

  • Computerized system principles and guidelines
  • Computerized systems and GMP
  • Computerized systems and risk management
  • Computerized systems and continuous improvement

Module 12: GMP and Cleaning Validation

  • Cleaning validation principles and guidelines
  • Cleaning validation and GMP
  • Cleaning validation and risk management
  • Cleaning validation and continuous improvement

Module 13: GMP and Environmental Monitoring

  • Environmental monitoring principles and guidelines
  • Environmental monitoring and GMP
  • Environmental monitoring and risk management
  • Environmental monitoring and continuous improvement

Module 14: GMP and Water Systems

  • Water system principles and guidelines
  • Water systems and GMP
  • Water systems and risk management
  • Water systems and continuous improvement

Module 15: GMP and HVAC Systems

  • HVAC system principles and guidelines
  • HVAC systems and GMP
  • HVAC systems and risk management
  • HVAC systems and continuous improvement

Module 16: GMP and Pest Control

  • Pest control principles and guidelines
  • Pest control and GMP
  • Pest control and risk management
  • Pest control and continuous improvement

Module 17: GMP and Waste Management

  • Waste management principles and guidelines
  • Waste management and GMP
  • Waste management and risk management
  • Waste management and continuous improvement

Module 18: GMP and Training

  • Training principles and guidelines
  • Training and GMP
  • Training and risk management
  • Training and continuous improvement

Module 19: GMP and Documentation

  • Documentation principles and guidelines
  • Documentation and GMP
  • Documentation and risk management
  • Documentation and continuous improvement

Module 20: GMP and Record-Keeping

  • Record-keeping principles and guidelines
  • Record-keeping and GMP
  • Record-keeping and risk management
  • Record-keeping and continuous improvement


Certificate of Completion

Upon completion of this course, participants will receive a certificate issued by The Art of Service. This certificate confirms that the participant has completed the course and has demonstrated a thorough understanding of the principles and practices of GMP.

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