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FDA Medical Device Inspections: What To Expect During a FDA Medical Device...

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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FDA Medical Device Inspections:

What To Expect During a FDA Medical Device Quality Systems Inspection and How to Prepare for The Inspection.

Wednesday, July 24, 2019, 7:00 to 9:00 pm

Topic: FDA Medical Device Inspections

ABSTRACT:
This seminar provides a view of what to expect when a medical device manufacturer receives notification of an
FDA quality system inspection and suggestions for policies that can expedite inspections with more favorable
outcomes. Having foresight into what topics/questions/records are typically covered during an FDA inspection
helps a manufacturer to be better prepared for expediting the inspection and minimizing the number deficiencies
the investigator may find, i.e.: FDA483 Inspectional Observations. Depending on the device, the inspection can
cover FDA regulation sections §803, 806, 820, and 1000-1040. The seminar will also cover some FDA-483
Inspectional Observations.

Note: We believe this will be a well-attended Round Table. Be sure to reserve your seat soon. There will be a practical limit of 90 attendees. Please register early to ensure admission.


FEATURED SPEAKER:
Frank Eng worked 42 years as an FDA investigator, specializing in medical devices and laser products. Frank
is well known in Silicon Valley as a fair and respected investigator. He has been on the NCDG Planning Team
for several years now and brings a welcome and competent regulatory voice to our discussions.

Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035 Click here for map and

Moderator: Barry Craner, former VP QA.RA, Stellartech Research Corp, Past Chair ASQ Biomedical Division, Past Chair ASQ San Diego Section, FASQ, CQE, CRE, CQA, CBA.

Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035

Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.

Email: To be added to or removed from our email list, contact George Marcel, gjmarcel@gmail.com.

Registration Link: http://ncdgjul2019.eventbrite.com/

ONLY Check or Credit Card accepted at door

Questions: For information about this session, contact: Barry Craner, at CranerASQ@gmail.com.

Formal discussion and questions will end between 8:30 - 8:40 pm to allow time for networking.

Materials: Presentation & workshop sheets provided for onsite attendees only. Please limit distribution to attendees: personal professional use only.

Webinar Remote Access (no cost):

https://attendee.gotowebinar.com/rt/8290285084177151234







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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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