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.
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Upon successfully completing this course, trainees 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 facility
- Distinguish when and why some GLPs are neither required nor appropriate
- Define and apply FDA and OECD requirements
Regulatory affairs, quality control, and quality assurance coordinators, and quality engineers 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.