2020 Concept to Commercialization Virtual Series: FDA Regulations for Medical Device

September 30, 2020
2:00 - 3:00 PM EST

2020 Concept to Commercialization Virtual Series
Sponsored by:    Business Incubator Association of NYS (BIANYS); 
CenterState CEO; Innovation Law Center - Syracuse University College of Law; MedTech; TDO; SUNY Research Foundation; and CNY Biotech Accelerator, Upstate Medical University

Register in advance for this series: 

https://upstate.zoom.us/meeting/register/tJwpcOiopzsjGdd9kicDnvgOklQMJps2TQ8q

 

The Virtual Series runs September 9 through December 16 - register for any/all of the following sessions using the link noted above.

FDA Regulations for Medical Device*

Wednesday, September 30, 2:00 – 3:00 p.m.
Gary Brennan MBA - Owner GGPC Consulting
Expert with over 25 years of QA/RA experience will include quality and regulatory topics: Medical Device Regulatory Strategy, 510(k) Submissions, Technical File Creation, Standards Development, Labeling and UDI.

IndieBio New York
Monday, October 5, 2:00 – 3:00 p.m.
IndieBio, the biotech accelerator behind companies such as Geltor and Jungla, has opened a location in New York City. Come meet the IndieBio team and learn about the inaugural cohort of startups! In this panel conversation, the IndieBio New York team will discuss their companies, their program, and the future of biotech. What support can VC funding provide to startups? How do accelerators help startups succeed? Bring your questions and learn more during our discussion.
Panel will consist of: Stephen Chambers, Managing Director; Sam Lee, Program Director and Julie Wolf, Communications Director

Design Controls, Verification & Validation*
Wednesday, October 14, 2:00 – 3:00 p.m.
Sarah Burlingame, Senior Project Director, TDO
Sarah Burlingame, a Senior Project Manager at TDO, the Central New York MEP Center, will provide an overview of the Design requirements for ISO 9001:2015. The various stages of design as well as important design aspects (including the need for structured and documented controls, verification and validation) will be reviewed.

NYS MEPs – Manufacturing Extension Partnership Panel
Tuesday, October 20, 2:00 – 3:00 p.m.
Panel will consist of:
Jim D’Agostino, MEP Center Director, TDO; Cory Albrecht, AIM Center Director, MVCC MEP; Annette Brenner, Sr. Business Advisor, NextCorps; and Steve Melito, Solutions Specialist, FuzeHub
The New York Manufacturing Extension Partnership (NY MEP) is a network of organizations that provide growth and innovation services to small and mid-sized manufacturers in every corner of the state to help them create and retain jobs, increase profits, and save time and money. NY MEP panelists will discuss the wide array of services that they provide to manufacturers of all sizes, as well as available funding.

The Tech Garden and the Hotspot Program
Tuesday, October 27, 2:00 – 3:00 p.m.
Jeannine Rogers, Program Manager and Kara Jones, Content and Strategy Manager, The Tech Garden
Learn about the HotSpot program and tax benefits available to tech and manufacturing start-ups through The Tech Garden, as the CNY Innovation HotSpot, and its HotSpot partners.

Quality Systems*
Wednesday, November 4, 2:00 – 3:00 p.m.
Dave Johnson
Presenter will provide an overview of the Quality Systems (QS) or current good manufacturing practices (CGMP’s), which manufacturers must establish and follow to ensure that their products consistently meet established requirements.

How to Sell Your Product: Channel, Sales Strategy, Selling Methods and GPOs
Wednesday, November 11, 2:00 – 3:00 p.m.
Courtney Chiavara Perrone, Senior Manager Sales Enablement and Program Manager, Commercial Operations, Hillrom, and Jamie Wood, Director of Commercial Operations, Hillrom
Presenters will discuss post market selling, relationships and channel strategies.

Good Clinical Practice (GCP) Regulations and Clinical Trials*
Wednesday, November 18, 2:00 – 3:00 p.m.
Kathi Durdon, CCRP, Executive Director, CNYBAC
Ms. Durdon, a SOCRA clinical research certification instructor, will provide an overview of FDA GCP regulations in the conduct of research involving human subjects where data supports an FDA submission.

Startup Resources: Business & Financial CultureS
Wednesday, December 2, 2:00 – 3:00 p.m.
Kurt M. D’Angelo and Sean Richardson, Financial Consultants, Equitable Advisors
Presenters will discuss the stages of startup timeline relative to potential funding and resources to assist in the financial process.

Export Information for Small Businesses
Wednesday, December 9, 12:00 – 1:00 p.m.
Steven King, Director of the Central New York International Business Alliance will provide an overview of exporting for SME’s. This will include examples of export assistance services, services to find you buyers, how to find grants to support exporting and dealing with export regulations.

Issues to Consider Before Fundraising: Financial Housekeeping for Startups
Wednesday, December 16, 2:00 – 3:00 p.m.
John Pennett, Partner, EisnerAmper
This session will discuss key issues to consider before fundraising, raising the right amount of capital, what VCs look for in an investment opportunity, and being “diligence ready.”


*These presentations qualify for SOCRA or applicable research/regulatory-related Certificate of Attendance towards recertification purposes at 1 hr/1 credit each.
Where speakers have approved to have their session recorded, recording link will be provided to registrants following the session.

 

 For more information contact:  cnybac@upstate.edu

 

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