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CGMP a Complete Guide

CGMP a Complete Guide

USD211.69
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CGMP: A Complete Guide



Course Overview

This comprehensive course provides a thorough understanding of Current Good Manufacturing Practices (CGMP) for the pharmaceutical, biotechnology, and medical device industries. Participants will gain a deep understanding of the regulations, guidelines, and best practices for ensuring the quality, safety, and efficacy of products.



Course Objectives

  • Understand the history and evolution of CGMP
  • Learn the key principles and guidelines of CGMP
  • Understand the role of CGMP in ensuring product quality, safety, and efficacy
  • Apply CGMP principles to real-world scenarios
  • Develop a comprehensive understanding of CGMP regulations and guidelines


Course Outline

Module 1: Introduction to CGMP

  • History and evolution of CGMP
  • Key principles and guidelines of CGMP
  • Overview of CGMP regulations and guidelines
  • Importance of CGMP in ensuring product quality, safety, and efficacy

Module 2: CGMP Regulations and Guidelines

  • Overview of FDA regulations and guidelines
  • Understanding 21 CFR Part 211
  • Understanding 21 CFR Part 820
  • EU GMP regulations and guidelines
  • ICH guidelines

Module 3: Quality Management Systems

  • Overview of quality management systems
  • Understanding ISO 9001
  • Understanding ISO 13485
  • Quality policy and objectives
  • Quality planning and control

Module 4: Facility Design and Construction

  • Overview of facility design and construction
  • Understanding cleanroom design and construction
  • Understanding HVAC systems
  • Understanding water systems
  • Waste management and disposal

Module 5: Equipment and Instrumentation

  • Overview of equipment and instrumentation
  • Understanding equipment qualification and validation
  • Understanding calibration and maintenance
  • Understanding instrumentation and control systems
  • Computerized systems and software validation

Module 6: Materials Management

  • Overview of materials management
  • Understanding material sourcing and procurement
  • Understanding material storage and handling
  • Understanding material testing and inspection
  • Supplier qualification and management

Module 7: Production and Process Controls

  • Overview of production and process controls
  • Understanding batch processing and control
  • Understanding continuous processing and control
  • Understanding process validation and verification
  • Understanding cleaning and sanitization

Module 8: Packaging and Labeling

  • Overview of packaging and labeling
  • Understanding packaging design and development
  • Understanding packaging materials and components
  • Understanding labeling and labeling controls
  • Understanding packaging and labeling regulations and guidelines

Module 9: Laboratory Controls

  • Overview of laboratory controls
  • Understanding laboratory design and layout
  • Understanding laboratory equipment and instrumentation
  • Understanding laboratory testing and inspection
  • Understanding laboratory data management and reporting

Module 10: Documentation and Record Keeping

  • Overview of documentation and record keeping
  • Understanding document control and management
  • Understanding record keeping and retention
  • Understanding electronic records and electronic signatures
  • Understanding documentation and record keeping regulations and guidelines

Module 11: Training and Competence

  • Overview of training and competence
  • Understanding training needs assessment and planning
  • Understanding training delivery and evaluation
  • Understanding competence assessment and evaluation
  • Understanding training and competence regulations and guidelines

Module 12: Audits and Inspections

  • Overview of audits and inspections
  • Understanding audit and inspection types and purposes
  • Understanding audit and inspection preparation and planning
  • Understanding audit and inspection execution and reporting
  • Understanding audit and inspection follow-up and closure

Module 13: Corrective and Preventive Action

  • Overview of corrective and preventive action
  • Understanding corrective action and preventive action concepts
  • Understanding corrective action and preventive action procedures
  • Understanding corrective action and preventive action implementation and evaluation
  • Understanding corrective action and preventive action regulations and guidelines

Module 14: Continuous Improvement

  • Overview of continuous improvement
  • Understanding continuous improvement concepts and principles
  • Understanding continuous improvement tools and techniques
  • Understanding continuous improvement implementation and evaluation
  • Understanding continuous improvement regulations and guidelines


Certificate of Completion

Upon completion of this course, participants will receive a Certificate of Completion issued by The Art of Service.



Course Features

  • Interactive and engaging content
  • Comprehensive and up-to-date information
  • Personalized learning experience
  • Practical and real-world applications
  • High-quality content and expert instructors
  • Certification upon completion
  • Flexible learning schedule
  • User-friendly and mobile-accessible platform
  • Community-driven and interactive discussions
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking
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