Live Webinar Medical device cybersecurity following latest FDA Guidance

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Description

June 6, 2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

The company must establish a program where they identify, analyze and control cybersecurity risks. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to device users. A complex set of reporting requirements have been established with some exceptions. This webinar will describe a program that will be compliant with the FDA requirements

Why should you attend

Medical device cybersecurity has become very important to the FDA. They have issued two recent guidances on the subject; the latest in December of 2016. FDA expects a proactive extensive risk-based program to minimize risk to the user from cyber attacks including involvement with information sharing groups.

Areas Covered

-- Cybersecurity plan
-- Risk-based analysis
-- Hazard analysis following ISO 14971
-- Risk communication to users
-- Required membership in information sharing groups
-- Reporting requirements and the exceptions

Who will Benefit

-- Development Engineers
-- Production Management
-- QA/QC Personnel
-- Software Developers
-- IT Personnel
-- company management
-- Cybersecurity , ISAO, risk,

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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