Process validation – Medical Devices

What does process validation mean for medical devices?
Which manufacturing processes need to be validated?
How should we prepare for the different steps in process validation, how should we perform them and how should we document?

These are some of the questions you will get answered in this one-day overview course regarding process validation of manufacturing processes for medical devices.

The course is a live interactive online course led by an experienced instructor, where participants explore the different elements of process validation through theory, group exercises and peer networking. It will cover which regulations apply, the meaning of commonly applied concepts in process validation and what needs to be done to maintain the validated state. Specific examples are given of what to include in the steps IQ/OQ/PQ.

The course is founded on the principles outlines in “Quality Management Systems – Process Validation Guidance” from GHTF (Global Harmonization Task Force) but will also address FDA interpretations and expectations in this area.

Please note: The course does not deep dive into statistical methods, design of experiments or the specific requirements that apply to method validation, validation of computerized systems or validation of the sterilization processes.   Consult our course catalogue for more in-depth knowledge in these areas.

Contents

• Why we validate and what to validate
• How we prepare for process validation: Product and process knowledge
• Regulations, standards and guidelines
• Setting requirements and using risk thinking in validation
• IQ, OQ and PQ according to GHTF
• Maintain validated state

Training objectives

After completing the training, the participants gain increased knowledge about both the preparations required and the main parts that are included in process validation for medical devices. With the help of active participation in exercises and discussions, the participants also gain an increased understanding of how the requirements are applied in practice and tools for how it can be done for your processes. The participants gain knowledge of guidelines and standards that help you in the practical work of producing documentation, protocols and reports that meet the authorities’ expectations.

Need for prior knowledge:

• You should have completed our Basic Course in GMP and Quality Systems or have equivalent prior knowledge
• You should have worked at least 6 months in regulated activities in the Medical Device industry.

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