GMP Foundations: Securing Quality Throughout the Primary Process
This training provides participants with a practical overview of the key GMP principles and quality systems along the product journey, from starting materials to finished product distribution and lifecycle management.
GMP regulators are putting more and more focus on a thorough understanding of the primary process. In the (bio-) pharmaceutical industry, building in product quality starts long before the final release. Understanding how GMP and quality systems support every phase of the primary process is essential to understand the full complexity and coherence of the GMP regulations and for ensuring patient safety, product consistency and availability plus regulatory compliance.
During this training, participants will gain insight into the GMP requirements, controls, and quality systems that support the different stages of the manufacturing process.
The training combines theory with practical examples and industry best practices to help participants understand how quality is secured throughout the entire process chain and how all aspects of the GMPs work together to reach this goal.
Objectives
After completing this training, participants will be able to:
Understand the basic principles of GMP and pharmaceutical quality systems
Explain the importance of quality controls throughout the primary process
Recognize GMP requirements related to starting materials, production, and finished products
Understand the role of documentation, traceability, and process control
Identify key risks, critical control points, and common GMP pitfalls
Describe how quality is maintained throughout the product lifecycle
Target group
This training is intended for professionals working in pharmaceutical, biotech, and life sciences environments who are involved in, or interact with, GMP-regulated processes, including:
Operators and technicians
Manufacturing and production staff
QA and QC professionals
Process support staff
Supply chain and warehouse employees
New employees entering a GMP-regulated environment
Professionals seeking a broader understanding of GMP across the product lifecycle
Program 9.00-17.00
Topics