Good Laboratory Practices & Biological Evaluation for Medical Devices
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.
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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
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.
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.