Having grasped the basics of GMP in MD-GMP I, an operator now needs to move on to more advanced GMP concepts.
Advanced GMP for Medical Device Operators covers everything a trainee needs to know about more demanding CGMP topics such as SOPs, completing records, use of computers, etc.
Standard Operating Procedures (SOPs) and records are critical in ensuring that operators are working in compliance with CGMP.
This course begins by explaining why SOPs must be followed in medical device facilities and what information they should contain.
It also describes the proper completion of records in medical device manufacturing including production records, equipment records, and records of materials.
Finally, the basics of Information Technology and Good Computer Practice are explained.
Topics covered:
GMP - SOPs for Medical Devices GMP - Records for Medical Devices Medical Devices – Personnel & Training IT Use in Regulated Industries
Certificate:
There is a 16 question assessment associated with each lesson within the Course and we offer a Certificate Service in which Users who achieve 100% in the assessment associated with each Lesson of a Course are deemed to have passed the Course, and are posted a Certificate.
