Course Description

Good Laboratory Practices & Biological Evaluation for Medical Devices

Course Description:

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.


Learning Objectives:

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

Who Should Enroll:

Regulatory Affairs Coordinators, Quality Control Coordinators, Quality Assurance Coordinators and Quality Engineers


Prerequisite Knowledge/Requirements:

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.   


Subject Matter Expert:
Neil Burris

Duration:
70 min

Release date:
05/21/2010

Related resources:
Yes

Case studies:
Yes

Price:
Basic Account: € 213.00
Premium Account: € 160.00

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