Skip to main content
Mastering GxP; A Comprehensive Guide to Good Practice Regulations in the Pharmaceutical Industry

Mastering GxP; A Comprehensive Guide to Good Practice Regulations in the Pharmaceutical Industry

$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

Mastering GxP: A Comprehensive Guide to Good Practice Regulations in the Pharmaceutical Industry



Course Overview

This comprehensive course provides an in-depth understanding of Good Practice (GxP) regulations in the pharmaceutical industry. Participants will gain a thorough knowledge of the principles, guidelines, and regulations that govern the development, manufacturing, testing, and distribution of pharmaceutical products.



Course Objectives

  • Understand the principles of GxP regulations and their application in the pharmaceutical industry
  • Learn about the different types of GxP regulations, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP)
  • Understand the role of regulatory agencies, such as the FDA and EMA, in enforcing GxP regulations
  • Develop skills in implementing and maintaining GxP compliance in pharmaceutical organizations
  • Learn how to conduct audits and inspections to ensure GxP compliance
  • Understand the importance of documentation and record-keeping in GxP compliance
  • Develop knowledge of the latest developments and trends in GxP regulations


Course Outline

Module 1: Introduction to GxP Regulations

  • Definition and principles of GxP regulations
  • History and evolution of GxP regulations
  • Types of GxP regulations: GMP, GLP, GCP
  • Regulatory agencies: FDA, EMA, ICH

Module 2: Good Manufacturing Practice (GMP)

  • Principles of GMP
  • Guidelines for GMP: WHO, FDA, EMA
  • GMP for pharmaceutical products: manufacturing, testing, packaging
  • GMP for active pharmaceutical ingredients (APIs)
  • GMP for finished pharmaceutical products (FPPs)

Module 3: Good Laboratory Practice (GLP)

  • Principles of GLP
  • Guidelines for GLP: OECD, FDA, EMA
  • GLP for non-clinical laboratory studies
  • GLP for clinical laboratory studies
  • GLP for analytical laboratory studies

Module 4: Good Clinical Practice (GCP)

  • Principles of GCP
  • Guidelines for GCP: ICH, FDA, EMA
  • GCP for clinical trials: design, conduct, monitoring
  • GCP for clinical trial sponsors
  • GCP for clinical trial investigators

Module 5: Regulatory Agencies and Enforcement

  • Role of regulatory agencies: FDA, EMA, ICH
  • Enforcement of GxP regulations: inspections, audits, penalties
  • Regulatory guidance: guidelines, recommendations, standards
  • Regulatory compliance: strategies, tools, techniques

Module 6: Auditing and Inspecting for GxP Compliance

  • Principles of auditing and inspecting
  • Types of audits: internal, external, third-party
  • Conducting audits and inspections: preparation, execution, reporting
  • Audit and inspection tools: checklists, questionnaires, rating systems

Module 7: Documentation and Record-Keeping

  • Importance of documentation and record-keeping
  • Types of documents: SOPs, protocols, reports, records
  • Document control: creation, review, approval, revision
  • Record-keeping: storage, retrieval, retention, disposal

Module 8: Implementing and Maintaining GxP Compliance

  • Strategies for implementing GxP compliance
  • Tools and techniques for maintaining GxP compliance
  • Training and awareness programs for GxP compliance
  • Continuous improvement and quality management

Module 9: Latest Developments and Trends in GxP Regulations

  • Update on recent changes and revisions to GxP regulations
  • Emerging trends and issues in GxP compliance
  • New technologies and innovations in GxP compliance
  • Best practices and lessons learned in GxP compliance


Certificate of Completion

Upon completion of this course, participants will receive a certificate 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 and recognition
  • Flexible learning options: online, self-paced, mobile-accessible
  • User-friendly and intuitive interface
  • Community-driven and supported
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking
,
!