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E-Learning Course: Advanced GMP for Medical Device Operators (Certified)
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.
This course consists of the following four modules:
- GMP - Records for Medical Devices
- Medical Devices - Personnel and Training
- IT Use in Regulated Industries
- GMP - SOPs for Medical Devices
This is a self paced highly visual interactive e-Learning course, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice assessment which the trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.
(1) GMP - Records for Medical Devices
This Skillpad GMP Module is ideal for people who are new or existing employees of the Medical Device sector and who are required to work according to GMP. The Module outlines the fundamental rules for completing records and discusses the requirements of the most frequently encountered records. Records include Device History Records, Equipment Records and Acceptance Activity Records.
- Define what records are
- Describe the general rules for completing records
- Explain what a quality system is and why medical device manufacturing companies use them
- List the information that must be entered on frequently used records
- List the types of records required in a medical device manufacturing company
(2) Medical Devices - Personnel and Training
This Skillpad GMP Module is ideal for people who are new or existing employees of the Medical Device sector and who are required to work according to GMP. The Module describes GMP requirements for personnel in medical device facilities, including training, clothing, hygiene and health requirements. Examines who must be trained on what.
- Explain the importance of a quality system
- Explain the importance of training in the medical device industry
- Explain what is included in training documentation and why records of all training must be kept
- Identify the three main types of training that are performed in medical device plants and explain what each of them covers
- List the GMP requirement for training and personnel
(3) IT Use in Regulated Industries
This Skillpad Module is ideal for people who work in the API, Biotech or Pharmaceutical sectors and are governed by the Rules of the FDA's 21 CFR11 and the Eudralex Annex 11. The Module explains the basics of Information Technology and Good Computer Practice and looks at how IT is used in regulated industries.
- Define computer network, LAN and WAN
- Define Internet, e-mail, intranet and World Wide Web
- Describe the importance of computer security in regulated industries
- Describe the various uses of IT in regulated industries
- Distinguish between computer software and computer hardware
- Explain what is meant by the term 'Information Technology'
- List and describe the rules for good computer practice
(4) GMP - SOPs for Medical Devices
This Skillpad GMP Module is ideal for people who are new or existing employees of the Medical Device sector and who are required to work according to GMP. The Module explains what an SOP is, why SOPs must be followed in Medical Device Plants and what information they should contain.
- Define Standard Operating Procedures
- Explain why SOPs are used
- List the rules that must be followed when using SOPs
- List the types of information contained in SOPs