Events

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!

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.

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.

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.

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.

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!

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.

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.

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...

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.