Introduction to the Manufacture of Sterile Medicinal Products for Operators|company
Get New Operators Ready to Work in Your Sterile Manufacturing Environment
The course prepares new operators to work in accordance with GMP requirements within your organization and provides them with a clear understanding of the requirements that apply to sterile manufacturing.
At the same time, they are introduced to the mindset required when working in the manufacture of sterile medicinal products in a GMP-regulated organization.
Qualification and Validation – From Requirements to Testing|company
Learn the Basics of Qualification and Validation
Gain an understanding of the qualification and validation requirements when new equipment or processes are introduced in pharmaceutical manufacturing—and learn how to ensure traceability from requirements to testing.
Process Validation
Take control of your process validation
Learn how to ensure product quality throughout its lifecycle. This course provides in-depth knowledge of process validation, including the application of advanced tools and an understanding of regulatory requirements from the EMA and FDA.
Introduction to Qualification and Validation
Become familiar with the principles and concepts of qualification and validation
The course consists of two e-learning modules as preparation. They cover qualification and validation requirements, as well as qualification phases. During the course itself, the relationship between qualification phases, documentation, and qualification tests is reviewed, along with practical tips and tricks for these processes.
Equipment Qualification
Get ready to handle qualification documentation on your own and ensure that your equipment meets GMP requirements
This course will equip you with the necessary skills to independently handle equipment qualification and ensure that your organization complies with regulatory requirements and GMP standards.
Get Excel Under Control
Learn how to create user-friendly and robust Excel spreadsheets that remain under control, even when used by others
Get practical tools and tips for building Excel worksheets, complete with documentation of their structure, that have been tested and verified for accuracy before being released for use.
Validation of IT Systems
Understand and apply current standards for IT validation
Learn how to manage IT system validation and ensure data integrity and compliance. This course provides you with the tools you need to understand requirements, apply best practices, and strategically plan and execute IT validation activities.
Fundamentals of Quality Risk Management
Get Hands-On Experience with Quality Risk Management
Gain insight into Quality Risk Management (ICH Q9), understand its core principles, and learn how to apply them in practice.
Qualification and Validation – From Requirements to Testing | Company
Master the basics of qualification and validation
Understand the requirements for qualification and validation when new equipment or processes are to be used in pharmaceutical manufacturing—and learn how to ensure traceability from requirements to testing.
Introduction to the Manufacture of Sterile Medicines for Operators | Company
Get ready to start working as an operator in your sterile pharmaceutical production facility
The course prepares new operators to work in accordance with GMP regulations within your organization and provides them with a clear understanding of the requirements that apply to sterile manufacturing.
At the same time, it introduces the mindset necessary for working with the manufacture of sterile pharmaceuticals in a GMP-regulated company.