QMS & Medical Device Software Validation
This 3 day course will give attendees a good grounding in the requirements for Medical Device Software validation and Quality Management Systems (QMS) Software validation. The course will cover the implementation of those requirements through Software Validation and Medical Device Software Life Cycles Processes and will cover the applicable requirements from both the Europe and the US.
Dates & Location
Tuesday, 17th - Thursday 19th September 2019
09.00 - 17.00
Sheraton Hotel Athlone, Co. Westmeath
Who should attend?
Developers of Medical Device Software, and IT, Engineering and Quality personnel who need to gain a foundation in the principles and practices of QMS and Medical Device Software Development and Validation.
What will I Learn?
Participants achieve the following learning outcomes from the programme;
- Apply the principles of Software Validation to QMS Software.
- Implement the Validation Life Cycle and GAMP 5approach to QMS Software
- Apply Quality Risk Management techniques.
- Generate key validation documents such as URS, FDS, VMP, IQ, OQ and PQ.
- Apply the requirements of 21 CFR part 11 in relation to Electronic Signatures & Records.
- Apply the principles of Medical Device Software Development and Validation.
- Identify the requirements of EN IEC 62304, EN IEC 62.
- Identify and generate the documents necessary to implement the Development/ Validation Life Cycle approach to Medical Device software.
- Implement Requirements for S.O.U.P.
- Implement software maintenance requirements.
- Implement software usability requirements.
- Write key validation requirements such as User Requirements and Test Cases
*This training is supported by the Connected Health Skillnet