MedTech Mega Mixer

MIX & MINGLE WITH OC’S BEST This is event is free for OCRA Members! Back by popular demand is the 3rd Annual Medtech Mega Mixer.  This event seeks to build a more cohesive Orange County, CA life science ecosystem by bringing together some of the...

Virtual Sip & Paint Night

Online

Virtual painting happy hour, guided by artist, Kimball Willson. This event is for all skill levels – if you have not painted before, come join us and learn; if you are used to painting, hope you still join us and have fun connecting with us!

$10 – $20

2021 OCRA Board of Elections

Online

Join the OCRA Board of Directors – Build your career and shape the future of our industry. Considering joining the OCRA 2021 Board of Directors? Submit your profile by October 15th, 2020.

GCP COMPLIANCE and FDA BIMO INSPECTION READINESS

  Program event co-organized by SDRAN and OCRA Webinar, Wednesday, 21 October 2020, 6:00-7:30 Click here to register for this event.   Program Speakers: Tommi Papson Former FDA Investigator and President and Co-founder of Regulatory Consultants Group                                                      Jacqueline Bushong      Sr. Director, Head of...

WAR FOR TALENT, OC MEDTECH EVENT

  Webinar organized by DeviceAlliance     Register Here EMPLOYMENT/ HIRING & EMPLOYEE RETENTION STRATEGIES The ‘War for Talent’ event seeks to address the current challenges of hiring and retaining employees from both the employer and employee perspective.  Attendees will hear from a distinguished panel...

Regulatory Affairs Leadership: Best Practices for Effective Management

Online

Succeeding and growing as a Regulatory Affairs professional within your business requires a holistic approach, subject matter expertise as well as leadership acumen. In this webinar we will explore key strategies and principles to foster effective communication and leadership to transform you from a regulatory professional into a strategic business partner.

$10 – $25

Top Risks to Human Factors Submissions and How to Avoid Them

Online

For the last 2 years, FDA has presented the statistics that only 4-11% of human factors (HF) submissions are acceptable upon first submission. This means 89-96% of HF submissions are not acceptable the first time they are submitted to FDA. When HF data are required for a regulatory submission, regulatory affairs professionals who desire a successful HF submission need to understand and be involved in certain critical aspects of the HF program and HF activities to ensure regulatory success.

$10 – $25

SDRAN: The New Roaring 20s and Advances in Gene Therapy Drug Development

REGISTER HERE   Event Agenda: Date: Wednesday, 18 November 2020 Time*: 6:00 – 6:05 PM  Welcome and Announcements (ONLINE) 6:05 – 7:05 PM   Program Presentation (ONLINE) 7:05 – 7:30 PM   Q & A (ONLINE) *Times are approximate. Speaker: Amanda Richter Executive Director, Regulatory Affairs Neurocrine...

ISO 14155:2020 – Clinical Trial Requirements Have Changed

Online

The Final Draft of the ISO 14155 has been released. The standard has many areas that are updated significantly. The update came from various sources besides continuous improvement, increased risk based approach (both for the investigational device – ISO 14971 as well as regarding the conduct of the clinical investigation itself), EU MDR, a stronger need for study design including statistical aspects, defining types of clinical investigations, and how ISO applies to each of them. Many subject matter experts have contributed to the many changes in this version of the standard. This workshop will provide you with an overview of the main changes, bring important information on the conduct of international clinical investigations, and how the standard concurs with the new EU-MDR requirements for clinical investigations.

$10 – $25

OCRA Holiday Celebration

Online

Toast to 2020 with the Orange County Regulatory Affairs Old and New Board!

Wear your most festive outfit and show your spirit! As Santa may show up!!!

We will also have FUN giveaways including…
Amazon Audible Gift Certificate, Total Wine Gift Certificate, & a Visa Gift Certificate!

Free

SDRAN: FDA Feedback from Recent Biocompatibility Submissions

Online

Program Speaker: Thor S. Rollins Director, Toxicology and E&L Consulting at Nelson Laboratories, LLC   Event Agenda: DATE: Wednesday, 20 January 2021 TIME*: 6:00 – 6.05 PM – Welcome - Erica Livingston & Sasi Mudumba 6:05 – 6.30 PM – Annual Meeting 6:30 – 7.30...

OCRA New Year Virtual Networking

Online

Thank you for being a supporter of the Orange County Regulatory Affairs (OCRA). To celebrate the NEW year, we are hosting a Virtual Networking!

Invite Others To Join! 

Join us for a OCRA Virtual Networking on Wednesday, January 27th at 5:30 pm via ZOOM. Come prepared to introduce yourself & network!

While this event is FREE, we are asking for all attendees to visit our website to update your information and check on your membership status.

Free

Cannabis: Quality Considerations in Inspections, Manufacturing, & Product Specifications

Legalization of marijuana and hemp has fueled competitive innovation and the adoption of technologies to advance production of various cannabis concentrates, derivatives, and infused-products.  How are these products regulated?  What local/state/federal regulations, codes, and standards apply to this nascent industry?  We will briefly explore food safety, public health, and occupational health and safety considerations during the cultivation, handling, processing, refinement, manufacturing, and labeling of products containing cannabis, cannabis concentrates, and cannabis-derived compounds.

$10 – $25

The New Paradigm: “Inspections during Covid”

Online Webinar

  A JOINT WEBINAR                                       Location:  Webinar  Program Manager: Tommi Papson, President, OCRA Speakers:  Conducting and Hosting Remote GLP Audits Ms. Angela Bazigos, CEO of Touchstone Technologies,...

Free

Turbulent Times in Europe: The Case for being Pro-Active

Online Webinar

A Hands-On To-Do Shortlist of Regulatory Action to be taken in 2021. Webinar 1.5 Hours Towards Your Continuing Education   Program Manager: Piet Lesage, Principal Consultant GB5D   Speakers: Jaap Laufer MD, PharmD, Medical Director at Emergo by UL. Ronald Baumans, Senior Consultant, Regulatory Affairs, Emergo...

$10 – $25

SDRAN: A Window into the Changing Landscape of FDA Drug Effectiveness Standards

Online Webinar

A Window into the Changing Landscape of FDA Drug Effectiveness Standards   Program Speaker: Frank Sasinowski Director at Hyman, Phelps & McNamara, P.C.   Wednesday, March 17, 2021   Event Agenda: DATE: Wednesday, 17 March 2021 TIME: 6:00 – 6:05 PM Welcome and Announcements 6:05...

After Brexit: The New UKCA and UKNI Marks. What Medical Device Manufacturers Need to Know

Online

Brexit is now over and as of January 1, 2021, medical device manufacturers are officially in a transition period until June 30, 2023. However, you must understand the current requirements for UK MHRA registration, obtaining the services of a new UK Approved Body, and working toward affixing the new UK CA or UK NI mark on medical devices entering Great Britain. Further, UK MHRA will not be utilizing the EU MDR or EU IVDR after the transition period but drafting brand new legislation for their new Medical Device/IVD approval scheme. While everyone is focused on the EU – do not forget the Great Britain market and these new requirements.

$10 – $25