Course Description

Good Laboratory Practices & Biological Evaluation for Medical Devices

Course Description:

This course provides insight into the basic principles and regulations of Good Laboratory Practices (GLPs) from a vocational point of view.

The course covers the following topics:

  • When GLPs are required
  • GLPs as sound business decisions
  • How GLP compliance can facilitate product “translation”
  • Choosing the right test facility (laboratory)
  • Biocompatibility testing
  • How to avoid the most common and costly manufacturing mistakes

GLP compliance is not only a global regulatory necessity during the pre-clinical testing of medical devices, but also an ethical and logical choice as it significantly contributes to the credibility of safe and reliable medical devices.

Watch the Course Trailer:



Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Comprehend the basic principles of GLPs
  • Identify which documents, rules, and regulations apply internationally
  • Investigate laboratory certification programs and determine what to look for when choosing a laboratory facility
  • Distinguish when and why some GLPs are neither required nor appropriate
  • Define and apply FDA and EU requirements

Who Should Enroll:

Regulatory affairs associates and managers, quality assurance associates, managers, and engineers, manufacturing, design, validation, electrical safety, and R&D engineers, purchasing and pre-clinical study managers, regulators, and notified body, internal, and lead auditors are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; however, the content assumes the learner has a general awareness of medical device regulations, standards, and guidance documents.  

Subject Matter Expert:
Neil Burris

70 min

Release date:

Related resources:

Case studies:

Basic Account: € 213.00
Premium Account: € 160.00

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