Laser and X-Ray Reports and Regulations

Webinar

Manufacturers of x-rays and instruments with lasers, inclusive of barcode readers, need to submit reports to FDA before entering the US market.

OCRA Series – Legal and Compliance Hot Topics: “Navigating Through the Covid-19 Pandemic”

Online

This will be a continuing forum that will primarily focus on hot topics in the legal and compliance realms, such as: privacy and data security matters; litigation and disputes; malpractice and insurance; contracts in the age of pandemic (e.g., force majeure clauses, Defense Production Act, etc.); product liability; IP; corporate; AI and robotics.

Free – $75

Global Emergency Use Authorizations (EUAs) & Accelerated Vaccine Development

Webinar

Educational Opportunity Global Emergency Use Authorizations (EUAs) & Accelerated Vaccine Development   May 14th, 2020 3:00 pm – 5:00 pm   2.0 Hours Towards Your RAC Recertification  We will explore time critical questions on Emergency Use Authorizations (EUA) Medical Device Regulatory Market Access and Accelerated...

Medtech Webinar: The Power of Advocacy – Medical Device Legislative Policy Impact: 5/21/2020

Online Webinar

RAPS Convergence is focused exclusively on regulatory for the healthcare products industry. Covering topics that find new ways to examine and solve regulatory challenges, Convergence includes expert-led educational sessions, pre-conference workshops on the hottest topics in the field and networking with the best regulatory professionals in the world.

Legal and Compliance Hot Topics: “PART 2: Navigating Through the Covid-19 Pandemic”

Online

This will be a continuing forum that will primarily focus on hot topics in the legal and compliance realms, such as: privacy and data security matters; litigation and disputes; malpractice and insurance; contracts in the age of pandemic (e.g., force majeure clauses, Defense Production Act, etc.); product liability; IP; corporate; AI and robotics.

Free

UK Medical Device Regulations after Brexit

Online

The UK regulatory body for Medical Devices, MHRA, has been very actively involved in shaping the EU’s new Medical device Regulations (MDR). As Brexit is now a reality, and as the political winds in the UK are driving towards more, rather than less independence from Europe, one can legitimately ask what could happen after Dec 31st, when EU law ceases to apply in the UK.

$10.00 – $25

Life Science Career Considerations Post-Covid

Online

Overview of life sciences job market, impacts of COVID on job (layoffs, pay reductions vs. manufacturing ramp ups and IVD line expansion), current needs, future opportunities.

Free

SDRAN: What is GDPR and How to Operationalize It?

Event Agenda: Date: Wednesday, 17 June 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: Erika Moncada Project Manager and Data Protection Manager MyData-Trust,...

ISO 14971:2019 – Quality System Impact

Online

 The new edition of ISO 14971:2019, Medical devices – Application of risk management to medical devices, has new definitions and updated requirements, as well as three informative annexes. Come and hear about the details of the 2019 revision and how this will impact your Quality Management System (QMS).

Device Alliance: Future of OC’s Medtech Innovation & Entrepreneurship

LOCAL ENTREPRENEURS DISCUSSING NEW FUTURE NORMS Join DeviceAlliance and our esteemed OC entrepreneur panelists as we take attendees through this live and interactive online webinar discussing the future of OC’s medtech entrepreneurship and innovation, taking into consideration our ever-changing landscape and ecosystem.   Discussions to...

Medical Innovation Exchange (MIx): MedTech Minds© June 2020

Jun 30, 6:30 PM – 8:00 PM Zoom Meeting Join MIx for a powerful virtual session of brainstorming, organized Q&A, and effective peer-to-peer mentoring. Learn how to navigate the Medtech industry during these confusing times. Make leaps and bounds this 2020 in MedTech.

Legal and Compliance Hot Topics: “BREAKING NEWS”

Online

Third Forum topic: "BREAKING NEWS” In this month's meeting we take a dive into recent FDA enforcement actions and trends that have had a financial and regulatory impact. We will review Official Action Indicated cases, or pending/final penalties. We will explore cases that highlight the need for Malpractice in the risk management realm.

Free

Fireside chat with California Drug and Medical Device Chief

Online

Keeping Informed & Working Together. We speak with the Section Chief, Harlan Loui on recent issues with Calif Department of Public Health- Food and Drug Branch  (CDPH-FDB) in regulating the drug and device industry (i.e. licensing requirements, inspections, etc.). Discussion about the Interactions and regulatory partners, joint inspections, with United States Food and Drug Administration (FDA), State Attorney General, District Attorneys and other regulatory agencies.

$10 – $25

SDRAN: Emergency Use Authorizations – Tales from the Trenches

Webinar Emergency Use Authorizations – Tales from the Trenches Program Speaker: Kim Walker Kim Walker Consulting     Event Agenda: DATE: Wednesday, 15 July 2020 TIME: 6:00 – 6:05 PM Welcome and Announcements (ONLINE) 6:05 – 7:05 PM Program Presentation (ONLINE) 7:05 – 7:30 PM...

OCRA Virtual Networking: July Membership Dash

Online

Thank you for being a supporter of the Orange County Regulatory Affairs (OCRA).To celebrate the launch of our NEW website and logo we are hosting a Membership Dash and Virtual Networking! Invite others to join! For every x5 Memberships that sign up referred by you, you will receive a FREE 1-Year OCRA Membership. Come prepared to introduce yourselves!

Free

Device Alliance 4TH Annual Women in OC Medtech

Webinar   4TH ANNUAL WOMEN IN OC MEDTECH JULY 23 @ 5:00 PM - 7:00 PM   LOCAL THOUGHT LEADERS DRIVING INNOVATION The Device Alliance is exciting to produce their 4th annual Women in OC Medtech event for 2020.  The past three years this has been their...

Legal and Compliance Hot Topics: “Data Integrity: What it means”

Online

Fourth Forum topic: "DATA INTEGRITY: WHAT IT MEANS” We will explore where things can go wrong and how the FDA evaluates clinical trial data. In this month’s meeting we will talk about roles and responsibilities in clinical trials including data integrity attributes and what it means to clinical investigators and companies. We will provide answers to the legality and questions about privacy of data. Key topics: Risks in Data Transmission, Where Things Can Go Wrong, Data Integrity Attributes.

Free