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Intended Use Workshop: The Foundation For All Things Regulatory
Tuesday 03 December 2019, 04:00pm - 08:00pm
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You are invited to an Evening Meeting

 

Networking and Educational Opportunity

 

Intended Use Workshop

The Foundation For All Things Regulatory

 

A single word in the Intended Use can change your regulatory strategies, marketing opportunities, and validation plans. Other impacts include speed to approval/clearance and speed to market.

 

 

December 3, 2019

4:00 – 8:00 pm

 

Join In-Person Workshop

Online Registration: https://www.eventbrite.com/e/intended-use-workshop-tickets-80990068475

 

3 Hours Towards Your RAC Recertification

 

Location:  MicroVention, Inc., 35 Enterprise, Aliso Viejo, CA 92656

 

Host and Program Manager:

Eri Hirumi, Manager, International Regulatory Affairs, MicroVention, Inc.

 

Presenter and Judges:

  • Eri Hirumi, RAC, Manager, International Regulatory Affairs, MicroVention, Inc.
  • Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant
  • TBD

 

 Schedule of Presentations:

 

4:00 – 4:30 pm     Check-In, Networking, and Refreshments

4:30 – 5:30 pm     Overview On The Importance and Impact of Intended/Indications For Use Statements

Speaker – Eri Hirumi, Manager, International Regulatory Affairs

5:30 – 6:00 pm     Workshop - Researching Potential Intended/Indications For Use Statements

6:00 – 7:00 pm     Contest – Building The Best Intended/Indications For Use Statement

7:00 – 7:15 pm     Judging the Winner

 7:15 – 8:00 pm     Q&A, Panel Discussion, and Closing Remarks

 

Synopsis:

The Intended/Indications For Use is the foundation of regulatory submissions for all products. This program will cover the following topics and incorporate a hands-on workshop. The workshop will culminate in a team project where the team with the most sustainable Intended/Indications for Use will be selected. The following topics will be evaluated for their impact on the Intended/Indications For Use:

  • Resources for researching competitive products
  • Difference between Intended Use and Indications For Use
  • Marketing impact
  • Registration impact – US and EU
  • Global
  • Product validation impact
  • Manufacturing

Please join us for a multi-faceted evening with some foundational learning and hands-on workshop with team building and networking opportunities. This program is designed to help Regulatory, Quality, Research and Development, Marketing, Manufacturing, and Project Management professionals.

 

Cost:

OCRA Members: $60 in-person attendance

Non-Members: $135 in-person attendance (includes 1-year OCRA membership fee)

Government and Students* in-person attendance: $35 for members or $70 for non-members (includes 1-year OCRA membership fee)

FREE for MicroVention Employees (please register for the FREE ticket option through Eventbrite)

 

Registration deadline is December 2nd. No same day or on-site registrations will be allowed. You must register for this event using Eventbrite: https://www.eventbrite.com/e/intended-use-workshop-tickets-80990068475

No multiple ticket purchases please. Please purchase one ticket at a time and use the attendee’s name

in order for that person to be listed on the security check-in list.

 

Speaker and Panelist Bios

 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, Quality, & Clinical 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 Extension. 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/intended-use-workshop-tickets-80990068475

Registration deadline is December 2, 2019.

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

 

No multiple ticket purchases please. Please purchase one ticket at a time and use the attendee’s name

in order for that person to be listed on the security check-in list.

 

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

 

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 November 26, 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.).

Location MicroVention, Inc., 35 Enterprise, Aliso Viejo, CA 92656
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