Good Laboratory Practices & Biological Evaluation for Medical Devices
GLP compliance is not only a global regulatory necessity during the pre-clinical testing of medical devices, but GLPs can also be an ethical and logical choice. This excellent and highly insightful course will take you not only through the basic principles and regulations surrounding GLP from a purely vocational point of view, but will also spell out the details as to when GLPs are required and even desirable as a sound business decision.
From how GLP compliance can facilitate product “translation” to choosing the right test facility (laboratory), followed by a brief introduction to biocompatibility testing, you will learn to avoid the most common and costly mistakes a device manufacturer can make.
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Upon completion of this course, trainees will be able to correctly and successfully:
- Comprehend the basic principles of GLP
- Identify which documents, rules and regulations apply worldwide
- Interpret laboratory certification programs and determine what to look for when choosing a lab
- Distinguish at what moment and why GLP is either required or appropriate
- Define and apply FDA requirements and OECD requirements
Regulatory Affairs Coordinators, Quality Control Coordinators, Quality Assurance Coordinators and Quality Engineers
There are no pre-requisites to this GLP presentation. However, the contents assume the learner has a general awareness of the regulations, standards, and guidance documents applicable to medical devices.