FREE Taster Class - ISO 14971 Risk Management for Medical Device | Peatixtag:peatix.com,2011:12021-11-15T09:08:15+08:00PeatixNealda YusofFREE Taster Class - ISO 14971 Risk Management for Medical Devicetag:peatix.com,2015:event-1104142015-08-20T14:00:00SGT2015-08-20T14:00:00SGT
LIMITED SEATS. Attendance on a first-com-first-serve basis.This
is a 2 to 3-hour FREE excerpt of the
interactive 1-Day workshop on medical device risk
management in accordance with the requirements of ISO 14971.
COURSE DESCRIPTION
Performing risk management is a regulatory obligation
and is the underpinning tool for assessing medical device safety. Risk
management is part of the design input requirements during product design &
development. This means that risk control and hazard reduction measures must be
included as key considerations in the final medical device design, as well as
in verification and validation studies. Risk evaluation should occur
continuously throughout the production and post-production processes.
This course offers a systematic methodology to
performing risk management using medical device examples. It also provides
guidelines on how to conduct productive meetings to construct medical device
risk profiles.
GET INSIGHTS ON THESE TOPICS:
1. Overview of the
ISO14971 medical device risk management process
2. Roles &
responsibilities in a risk management team
3. Constructing a risk
management plan
4. Applying the FMEA and
5x5 matrix in risk analysis
5. Relationship between
risk evaluation, risk control and medical device testing
6. Iteration of the risk
management process to evaluate residual risks
7. Overview of the risk
management file
8. Dealing with
unforeseeable risks in risk evaluation
ABOUT THE TRAINER:
Dr. Nealda Yusof has experience in the medical device
sector spanning more than 14 years. She was part of the pioneer medical device
team at the Health Sciences Authority
of Singapore as a regulatory professional from 2001 to 2003. In the next 7
years thereafter, she worked as a private
consultant specialising primarily in medical
device testing & data analysis, protocol development, manufacturing process
validation, risk evaluation, complaints investigation, recall crisis
management, process change validation and establishment of corrective &
preventive actions. During that time, she played a key advisory &
leadership role steering medical device design & development as well as
process development teams for a multinational renal care group. Her work
heavily involved onsite troubleshooting at manufacturing sites in Asia, Europe
and the Middle East.
Dr. Nealda Yusof obtained her Doctor of Philosophy
(Ph.D.) in Materials Science from the National University of Singapore, and a
Bachelor of Laws (LLB) with Honours from the University of Birmingham in the
United Kingdom.GET IN TOUCH:E-mail: global.training@semoegy.com