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BioOhio FDA Regulatory 101 Series – October 2016

October 27, 2016 @ 1:30 pm - 5:30 pm

BioOhio and Leadership Member Regulatory and Quality Solutions (R&Q) are excited to present an ongoing series of medical device “FDA Regulatory 101” events.

These sessions will cover a variety of regulatory topics such as FDA warning letter response, risk management, usability engineering, as well as a broad overview of medical device regulation in the US, Canada, and the European Union.

Each session of the FDA Regulatory 101 Series will cover a spotlight topic along with basic regulatory and quality principles. This cost-effective series is geared toward small and start-up companies, junior regulatory and quality staff, medical device development and manufacturing staff, or even seasoned regulatory and quality professionals wishing to brush up on current trends and expectations.

Agenda

1:30 – 2:00:  Regulatory Overview

2:00 – 2:30:  Quality Systems Overview

2:30 – 3:00:  Design Assurance Overview

3:00 – 3:30:  Product Quality Overview

3:30 – 3:45:  Coffee Break

3:45 – 4:15:  Post-Market Overview

4:15 – 4:45:  Spotlight Topic: Combination Products

4:45 – 5:30:  Q&A and Networking

Speakers

  • Nancy Morrison, Director of Regulatory Affairs, R&Q
  • Steve Keverline,  Director, Ohio Operations, R&Q
  • Jake O’Donnell (Former FDA), Senior FDA Compliance Principal, R&Q

In Partnership with

R&Q

Sponsored by

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The October 27 event will be in conjunction with Heal Ohio Conference (Oct. 27-28). While they are separate events, you are welcome to attend both. The discounted rate to attend the Heal Ohio Conference is $200 (normally $240).

Cost

Reg 101 Event + Heal Ohio Conference – $275

Reg 101 Event Only; BioOhio Member (companies w/ 10 employees or less) – $75

Reg 101 Event Only; BioOhio Member (companies w/ 11+ employees) – $125

Reg 101 Event Only; Non-members – $250

Reg 101 Event Only; BioOhio Student Members – $50

Please contact Jen Goldsberry at jgoldsberry@bioohio.com or (614) 675-3686 x.1004 for more information.

This event is a part of the [M]EDNEXT series. Presented by MAGNET, in partnership with BioOhio, [M]EDNEXT is a program designed to connect established manufacturing companies to critical biomedical knowledge and resources that will help them diversify their revenue streams by entering the growing medical manufacturing industry to create jobs and strengthen the local and state economy. The series is sponsored by JPMorgan Chase. Learn more about this series here.

Complimentary registration is available for auto or aerospace suppliers interested in becoming a medical device supplier. Contact jgoldsberry@bioohio.com for the discount code.

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Organizer

BioOhio
Phone:
(614) 675-3686 x 1263
Email:
sclay@bioohio.com
Website:
www.bioohio.com

Venue

Quaker Station at The University of Akron
135 South Broadway
Akron, OH 44325 United States
+ Google Map
Phone:
(330) 972-8215
Website:
https://www.uakron.edu/dining/catering/quaker-station-catering.dot