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GxP Foundations

Duration
3 Days

About this Learning Pathway

Learning Objectives for this Pathway include:


Understand Good Manufacturing Principles (GMP) principles and begin to familiarize yourself with the roles and responsibilities of different functional groups within the industry.

Topics covered:

  • Fundamental principles and regulatory standards of GMP.

  • History and purpose of GMP.

  • Personnel control.

  • Facility, utilities, and equipment controls.

  • Validation.

  • Quality control.

  • Batch release.

  • Change control.

  • Deviation control.

  • Documentation.

  • Regulatory inspections.


Gain a thorough understanding of Good Documentation Practices (GDocP) to ensure clarity in GMP terminology and establish a solid foundation for executing and documenting work in compliance with regulatory standards.

Topics covered:

  • Introduction to Good Documentation Practices.

  • Core Principles of GDocPs.

  • Practical Application of GDocPs.

  • Common pitfalls and how to avoid them.

  • Advanced GDocP Practices.


Develop the essential skill of effective communication with auditors, crucial for all professionals engaged in Good Manufacturing Practices (GMP). This course will equip you with the techniques to deliver pertinent information while maintaining concise and relevant responses to inquiries.

Topics covered:

  • Understanding Auditor Expectations.

  • Techniques for Clear Responses.

  • Delivering Pertinent Information.

  • Maintaining Concise Communication.

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