Medical device manufacturing companies generate a copious number of documents when implementing a Quality and a Regulatory Management System.
Various applications are available for purchase but at a high cost and unfortunately with ongoing maintenance license fees and the use of the service provider’s cloud systems which at times becomes questionable with current cybersecurity issues we all face.
This session will take through a new paradigm in work practices for managing documentation without the need to continuously search and question obsolescence and relevancy. It will introduce the use of Microsoft Excel and hyperlinks to manage particular areas of document and project management.
You will learn how to best manage your documents, remain compliant to ISO 13485 but most importantly eliminate one of the biggest time wasters when documents are saved by one person and retrieved by a different person in your organisation.
ISO 13485:2016 will be the reference document for all matters in this course.
Upon completing this course participants will:
This course is designed for all personnel tasked with, creating, maintaining ongoing updates of documentation associated with a Quality Management System and Regulatory Affairs. This includes individuals working in department with Quality Management Systems, Engineering and Regulatory Affairs accountabilities. The following personnel will benefit from the course:
Day 01(8:30 AM - 4:30 PM)
Day 02(8:30 AM - 4:30 PM)
George Azoury is principal and founder of RQSolutions. A leading consulting company located in Sydney, Australia, servicing the Medical Device Industry since 2002. Previous to this, George has held various local and regional positions in Regulatory, Compliance and Health Economics in a number of national and multinational companies. George is well known at both a local and global level with involvements with a number of companies ranging from the start-ups to the well-established manufacturing facilities in Europe, US and the Asia Pacific region.