Introduction to Validation of Software for Regulated Processes

This course is designed to give delegates an understanding of how to comply with FDA QSR §70 and 75, Part 11 and EN ISO 13485 requirements. Furthermore, the course will provide the delegates with tools for the validation process.

Background
The coming amendments to the Medical Devices Directive concerning software and the FDA’s Quality System Regulation requirements for software as expressed in 21 CFR 820.30(g), 70(i), 75 Part 11 eSignature and eRecords all requires the manufacturer to incorporate software life-cycle processes both for embedded software and software for regulated processes.

The updated standard EN ISO 13485:2016 requires the manufacturer to establish procedures for the validation of the application of computer software used in production and service provision. Such software applications shall be validated prior to initial and be proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications.

Learning objectives
This course is designed to give delegates an understanding of how to comply with FDA QSR §70 and 75, Part 11 and EN ISO 13485 requirements. Furthermore, the course will provide the delegates with tools for the validation process.

Course content

  • The 2-day course details the software validation requirements for processes that need to be addressed during design control [21CFR Part 820.30(g)] and [§7.3 of the EN ISO 13485] for proprietary software developments and for software developed by subcontractor.
  • There will be sessions on software risk management, development life-cycle, architecture, design, software verification and validation.
  • Software validation of Software of Unknow Providence (SOUP) purchased from third party vendors will also be covered.
  • Incorporation of EN ISO 14971, Medical devices – Risk management – Application of risk management to medical devices and AAMI /TIR 36 Validation of software for regulated processes will be shown
  • All current documentation of the FDA and EU software regulatory requirements will be included in the attached USB memory Stick.

The course format will include lectures, discussions groups and case studies.

Who should attend
The course is particularly suitable for those in the Healthcare Products industry who are actively engaged in developing or supporting software for regulated manufacturing processes and validation on electronic based Quality Management Systems.

Some knowledge of medical device regulatory management systems is assumed. However, there will be a brief introduction to ensure that everyone is "up to speed".

It is recommended that those attending the course either:

  • are or will be involved at some level in the implementation of compliance to FDA/EU Regulations and / or
  • have some experience of Programmable Systems, software development and validation and conformity assessment to FDA, Medical Device Directive (93/42/EEC) or other requirements

Course language
Slides in English. Presentations in Danish or if wanted by the delegates in English.
Course material in English

Instructors
Liselotte Blond Sørensen of Danish Medical Devices Consulting ApS
Poul Schmidt-Andersen of Danish Medical Devices Consulting ApS

"There were some fine discussions through the course, and the workshop's were also very good"

"Very knowledgable instructor, provided examples"

Deltagere, forår 2016

 

 

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Kontakt

Morten Petersen
Uddannelseskonsulent
49184703