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How to Write a 510(k)
Thursday 29 August 2019
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You are invited to a Half-Day Meeting

 

Networking and Educational Opportunity

 

How to Write a 510(k)

A review of 510(k) regulatory requirements, how select a predicate, and how manage FDA questions.

 

August 29, 2019

3:00 – 8:30 pm

 

Join In Person or On Webinar

 

Online Registration: https://www.eventbrite.com/e/how-to-write-a-510k-tickets-68658723089

 

5 Hours Towards Your RAC Recertification

 

Location:  

Applied Medical, 30200 Avenida de las Banderas, Building R105, Rancho Santa Margarita, CA 92688

 

Host:

Anna Feng, Regulatory Affairs, Applied Medical

 

Program Manager and Moderator:

Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant

 

Presenters and Panelists:

  • Nathalie Raad, Vice President of Regulatory Affairs, Applied Medical
  • Eri Hirumi, RAC, Manager of International Regulatory Affairs, Microvention, Inc.
  • Natalie J. Kennel, RAC (US), FRAPS, ASQ CQE & CMgr, President, NJK & Associates, Inc.
  • James (Rusty) Lusk, RAC (US/EU), Exemplar Global QS-LA (Ret. 2019), ASQ Mgr. Q/OE, QE, QA & HACCP, Principal, Quality Systems International
  • Paul Kramsky, Regulatory Consultant
  • Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant

 

Schedule of Presentations:

 

3:00 – 3:30 pm     Check-In, Networking, and Refreshments

 

3:30 – 4:00 pm     Overview of the Pre-Sub and 510(k) Programs

Speaker – Nathalie Raad, Vice President of Regulatory Affairs, Applied Medical

 

4:00 – 4:30 pm     How to Identify an Appropriate Predicate

Speaker – Eri Hirumi, RAC, Manager of International Regulatory Affairs, Microvention, Inc.

 

4:30 – 5:15 pm     510(k) Contents and RTA Checklist

Speaker – Natalie J. Kennel, RAC, ASQ CQE & CMgr, President, NJK & Associates, Inc.

 

5:15 – 5:45 pm     Break, Networking, and Refreshments

 

5:45 – 6:15 pm     Building a 510(k) – Project Management

Speaker – Eri Hirumi, RAC, Global Regulatory Affairs Manager, Microvention

 

6:15 – 7:00 pm     How to Respond to FDA

Speaker – James (Rusty) Lusk, RAC (US/EU), Exemplar Global QS-LA (Ret. 2019), ASQ Mgr. Q/OE, QE, QA & HACCP, Principal, Quality Systems International

 

7:00 – 7:30 pm     What To Do Once You Get Your 510(k) Clearance – Best Practices in Placing a Product on the Market

Speaker – Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant, Kim Walker Consulting

 

7:30 – 8:30 pm     Q&A, Panel Discussion – Recent 510(k) Experience from New and Seasoned Regulatory Professionals, and Closing Remarks

 

Synopsis:

We will review the basics of how to write and manage a 510(k).  Additionally, seasoned and new regulatory professionals will discuss their recent 510(k) experiences during a panel discussion.

 

Please join us for these learning opportunities and open discussions with industry professionals.

 

Cost:

OCRA Members: $120 in-person attendance or $80 webinar* attendance

Non-Members: $195 in-person attendance or $155 webinar* attendance (includes OCRA Membership fee)

Government and Students** in-person attendance: $60 for members or $95 for non-members (includes OCRA Membership fee)

Government and Students** webinar attendance:  $40 for members or $75 for non-members (includes OCRA Membership fee)

FREE for Applied Medical Employees (please email program host to be added to the list)

 

If you have any questions or require additional information, email OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.).

 

Registration deadline is August 28th.  No same day (in-person or webinar) or on-site registrations will be allowed.  You must register for this event using EventBrite:  https://www.eventbrite.com/e/how-to-write-a-510k-tickets-68658723089

 

*Webinar attendees: Email This email address is being protected from spambots. You need JavaScript enabled to view it. by August 28th for a link to the webinar.

** Government/Students:  Proof of government/student status required.


 

Speaker Bios

 

Nathalie Raad has over 13 years of experience in the medical device arena.  She started her career as a Product R&D Engineer at Applied Medical and has been in a Regulatory Affairs role since 2011.  Nathalie’s subject matter expertise lies in global regulatory affairs, design controls, risk management, usability, production and process controls, biocompatibility, and sterilization.  She mentors and guides her team in support of global pre-market regulatory affairs responsibilities such as medical device submissions (including numerous Class II device 510(k) submissions), new product development, product change management as well as aspects of quality management system compliance.  Nathalie enjoys systems engineering and process improvement projects, and has had numerous opportunities to apply her skills in a fast-paced, vertically integrated company that serves over 70 countries worldwide.  Nathalie earned her B.S. in Mechanical Engineering with a Biomedical Specialization from Southern Methodist University in Dallas, TX.

 

Natalie J. Kennel, FRAPS, U.S. RAC, ASQ CQE & CQMgr founded NJK & Associates to bring her practical perspective to medical device quality and regulatory affairs. With more than 30 years in the medical device industry, Kennel has hands-on development and manufacturing experience as well as in RA/QA and clinical roles in both major and start up medical device companies. She applies her expertise to the regulatory, quality and clinical needs of medical device companies.  Since forming her consulting business in 2005, she has submitted more than thirty-eight 510(k)’s, three de novo’s, and over 40 pre-submissions to FDA. She has prepared several international medical device submissions including for Canada, Australia, Europe, Singapore, Taiwan, and WHO.  The submissions support medical devices and in vitro diagnostic devices including, but not limited to, multiple orthopedic implants, intraocular lenses, infusion pumps, gynecological devices, complex medical monitoring and neurology equipment, software only products, molecular diagnostic systems and assays for infectious diseases, human genetic testing and oncology, various clinical chemistry and immunoassays, and point of care lateral flow assays.  She has implemented quality systems and provided on-going RA/QA support for several different companies.  She implemented quality systems and provided regulatory affairs support for a novel tissue bank.

 

Kennel has been published in RAPS regarding clinical trials for medical devices.  She has spoken on multiple regulatory, quality and clinical topics for SDRAN, ASQ and ACRP.  She has taught the medical device submission section for the U.S. RAC study group since 2002.  She has taught a seminar regularly for the USC regulatory affairs master’s program on software validation.  She has organized and chaired several SDRAN and SDRAN/OCRA events including on IVD’s, Corporate Compliance, and Supplier Interactions.   She has previously served as the President -Elect, President, and Vice President of Programs for San Diego Regulatory Affairs Network.  She holds a BS degree in Chemical Engineering from the University of Rochester. She can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

 

Eri Hirumi, RAC, Manager of International Regulatory Affairs at MicroVention, Inc., has a bachelor's degree and classwork in Biochemistry and Molecular Biology from Purdue and California State University at Long Beach.

Eri started her career as a Development Chemist for a very small electrophoresis product line that provided training on a broad spectrum of skills on the complete product life cycle. This training highlighted the key importance of managing documentation. The growing labeling knowledge sparked her interest in other parts of regulatory. Working on the labeling requirements led to an opportunity to lead the Technical publications group in Brea.  This in turn developed a detailed knowledge of world-wide IVD labeling requirements and the interplay with different standards. Eri shifted her career to into Regulatory Affairs.  She continues to expand her knowledge on global regulatory requirements. Different requirements such as chemical hazard communication, global registrations, import/export requirements, biological origin permitting and country of origin marking requirement were all interwoven into supporting a complete product life-cycle. Being an auditor for TÜV SÜD provided an excellent platform for building a solid foundation of Quality Management Systems as defined by EN ISO 13485 and the European regulatory processes and documentation requirements.  Eri is constantly expanding her knowledge base and now working with a Neurovascular Implant company as the regulatory landscape shifts to accommodate the MDSAP and the new EU MDR/IVDR. The past 2 years have been focused on supporting a fast-paced company dedicated to the developing and marketing neurovascular implants.  There managing global regulatory submissions has been a challenging but rewarding experience.

 

Kim Walker, MS, RAC (US & EU), FRAPS is an independent Global Regulatory Affairs and Quality Assurance Consultant and owner of Kim Walker Consulting since 2006.  In her consulting practice, she assists clients with pre- and post-market regulatory, clinical, and quality system needs.  Kim has served on the OCRA Program Committee since 2003 and, currently, serves as the Program Chair.  Additionally, she served on the OCRA Board of Directors 2004-2010, 2019 and was the 2008-2009 President.  Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3. Quality Management System: Continual Improvement.  She also has participated in the SDRAN Mentoring Program since 2009.  Kim participated on the CSUPERB Advisory Committee and Development Team for the Project Management in Clinical Trials certificate program through CSUF and, also, served as an instructor.  Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at UCI Ext.  She re-developed and currently teaches the “Medical Device Regulations” course for the SDSU Master of Science in Regulatory Affairs program. Kim developed and has taught an undergraduate “Medical Product Regulations: Bench to Bedside” course at CSUF with a focus on stem cell therapies since 2016.  She achieved both the US and EU RAPS Regulatory Affairs Certifications and has been accepted as a RAPS Fellow in recognition of her contributions and leadership in advancing the regulatory profession.  Additionally, Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development.  She has a BS in Bio-Medical Sciences and MS in Regulatory Affairs.  www.kimwalkerconsulting.com or This email address is being protected from spambots. You need JavaScript enabled to view it.

 

OCRA Registration Instructions

 

In-person registration fee includes light snacks, beverages, free parking and access to electronic presentations after the meeting (if approved by speaker for distribution).    

 

To register for this event go to: https://www.eventbrite.com/e/how-to-write-a-510k-tickets-68658723089

 

Registration deadline is August 28th

 

No same day (in-person or webinar) or on-site registrations will be allowed. 

 

*Webinar attendees: Email This email address is being protected from spambots. You need JavaScript enabled to view it. by August 28th to obtain a link to the webinar.

 

 

OCRA's non-profit Federal Tax ID# 33-0630455

 

 

Cancellation Deadline:

For a refund, please email your cancellation request to OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.) by August 22, 2019.

 

If you have any questions or require additional information, email OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.).

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