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Webinar On “Medical Device cybersecurity following latest FDA Guidance”

November 28, 2018 @ 1:00 pm - 2:00 pm

$229

Description :
The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market. 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 has been established. This webinar will describe a program that will be compliant to the FDA requirements.
Why :
Medical device cybersecurity has become very important to the FDA. They have recently issued two Guidance’s 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 active involvement with information sharing groups.

Areas Covered in the Session :
Cybersecurity plan
Risk based analysis
Hazard analysis following ISO14971
Risk communication to users
Required membership in information sharing groups
Reporting requirements and the exceptions

Who Will Benefit:
company management
IT personnel
Development Engineers
Production Management
QA/ QC personnel
Software developers

About Speaker:
Edwin Waldbusser retired from industry after 20 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. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.

Edwin Waldbusser 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.

Details

Date:
November 28, 2018
Time:
1:00 pm - 2:00 pm
Cost:
$229
Website:
https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD00118

Venue

Online Webinar
9106 Seven Locks Road
Bethesda, MD 20817 United States
+ Google Map
Phone:
1-844-216-5230
Website:
https://www.compliancetrainingpanel.com/Webinar/Topic?WB=FD00107
About Us

Tucson Lifestyle Magazine is Tucson's only glossy, monthly city magazine, targeting Southern Arizona’s affluent residents. With over 35 years of publishing experience, Tucson Lifestyle is committed to showcasing the people, places, local flavors, and attractions that make our city unique.

General Information

Phone: 520-721-2929 x 102
Address: 7000 E Tanque Verde Rd # 11,
Tucson, AZ 85715

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