Introduction to GMP and Quality Systems

What is GMP, and why is it essential in Life Science manufacturing?

This introductory course gives you a solid foundation in Good Manufacturing Practice (GMP) and quality systems, with a focus on the pharmaceutical industry but also touching on medical devices and IVDs. You’ll get an overview of regulatory expectations, quality risks, documentation, and the principles behind qualification and validation. Perfect for those new to the industry or transitioning into a regulated role.

What You’ll Learn:

· The history and purpose of GMP and quality systems

· Regulatory requirements in the EU and US for pharma and medical devices

· Fundamentals of equipment qualification and process validation

· Key documentation principles, including SOPs and data integrity

· The role of authorities and inspections

Who Should Attend:

New employees or consultants entering the regulated Life Science industry

Staff in quality, production, labs, logistics, or technical support

Prerequisites:

No prior experience required

Instructor:

Maria Axelsson, Senior Trainer – over 20 years of experience in the Pharma and Medtech Industry.