Validation and qualification

Course Description

Qualification of equipment and validation of manufacturing processes is necessary for patient safety and involves many different functions within a company. This validation and qualification course focuses on why we validate, how we do it and what regulatory requirements there are. Based on data from product and process development, we determine how to perform our qualifications and validations. The course also describes how the requirements are applied in practice in industry.

A review of GMP requirements for qualification and validation is combined with discussions and practical exercises. We review risk-based work methods throughout the life cycle of an equipment qualification as well as validation of manufacturing processes.

Specific requirements concerning validation of computerized systems, cleaning processes, and sterilization processes are not included in the course.

For these subjects we recommend the following trainings:
GMP requirements for Computer Systems and Data Integrity
Cleaning validation of pharmaceutical process equipment

Course content

• The foundation for validation work derived from pharmaceutical development
• How we should use a risk-based approach in validation work
• Basic regulatory requirements and concepts
• Qualification of equipment
• Process Validation
• Life cycle perspective and maintained validated status
• A number of exercises to exemplify and practice elements that are discussed during the course

Objectives

Participants will:

• understand why we validate
• learn development concepts that is the basis for validation, such as CQA/CPP
• understand how we can use risk-based methods in validation work
• know which regulations govern qualification and validation work in Europe and the US
• gain knowledge of guidelines and standards that can be helpful in validation work
• understand the basic concepts of qualification and validation and what they contain such as IQ/OQ/PQ/PV
• be familiar with the entire validation lifecycle and requalification/revalidation requirements

Who should attend

The course is valuable for those who work in or near pharmaceutical manufacturing and need an in-depth understanding of the requirements for validation and qualification. Perhaps you are involved in the purchase of equipment or are a supplier, and need to get an understanding of the requirements that are set from the beginning. Or are you the one who writes or reviews validation documentation and needs to know more about how the tests are developed and what they should contain. Regardless, after this course you will gain a deeper understanding and knowledge of why we validate, where the requirements come from, what is important and how we proceed throughout the validation lifecycle.

Prerequisites

• You should have completed our Basic Course in GMP and Quality Systems or have equivalent prior knowledge
• You should have worked for at least 6 months in GMP-regulated activities

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