Effective GMP Documentation in Your Organisation
Gain a clear understanding of regulatory requirements for proper GMP documentation and learn how to correctly complete and make corrections to batch documentation in a GMP-regulated environment.
About the course
Read about the benefits of a company course
Good documentation practices are essential in pharmaceutical manufacturing and form a central part of the quality management system and GMP compliance.
This company-focused course gives employees a common understanding of regulatory requirements for GMP documentation and the rationale behind internal requirements and procedures for good documentation practices.
It contributes to more consistent documentation practices across the organisation.
During the course, employees work with how to complete documentation correctly in practice and how to make corrections in accordance with applicable requirements.
After the course, employees will have an understanding of traceability and know how to write relevant and comprehensive comments in documentation.
The company’s own examples and types of documentation can be incorporated into the training, making the learning directly applicable to everyday work.
The course focuses on the connection between thorough documentation and quality assurance, and how employees contribute to this as part of their daily practice in a GMP-regulated organisation.
The training combines presentations, group work and case-based exercises, giving employees practical tools to strengthen documentation practices in their daily work.
This provides a common foundation for correct documentation and the handling of errors and corrections across the organisation.
Good documentation practices are essential in pharmaceutical manufacturing and form a central part of the quality management system and GMP compliance.
This company-focused course gives employees a common understanding of regulatory requirements for GMP documentation and the rationale behind internal requirements and procedures for good documentation practices.
It contributes to more consistent documentation practices across the organisation.
During the course, employees work with how to complete documentation correctly in practice and how to make corrections in accordance with applicable requirements.
After the course, employees will have an understanding of traceability and know how to write relevant and comprehensive comments in documentation.
The company’s own examples and types of documentation can be incorporated into the training, making the learning directly applicable to everyday work.
The course focuses on the connection between thorough documentation and quality assurance, and how employees contribute to this as part of their daily practice in a GMP-regulated organisation.
The training combines presentations, group work and case-based exercises, giving employees practical tools to strengthen documentation practices in their daily work.
This provides a common foundation for correct documentation and the handling of errors and corrections across the organisation.
Target group
The course is aimed at anyone working with documentation within pharmaceutical manufacturing, quality control or quality assurance who wants to improve their skills in good documentation practices.
Why choose this course
Benefits for employees
- You gain an in-depth understanding of why good documentation practices ensure consistent quality.
- You learn how to complete and correct documentation effectively.
- You understand the importance of traceability and develop the skills to write meaningful comments.
Benefits for the organisation
- Employees ensure that your documentation meets regulatory requirements.
- Employees become aware of the importance of traceability throughout the documentation process.
- Employees develop skills in correctly completing documentation and making corrections.
Course programme
09:00 – 16:00
The course consists of presentations, exercises and case studies.
- GMP requirements for good documentation practices
- Traceability and data integrity
- Completing documentation
- Writing effective comments
- The right quality mindset
Register for the course
Course Good Documentation Practice|company
Format 1 day in-company
Price 45.300 kr. excl. VAT
Choose a date and sign up
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