OECD Data Integrity US and International Compliance

Online Webinar

OECD Data Integrity US and International Compliance 1.5 CE Contact Hour Location: ZOOM Webinar Speaker: Eric Pittman, Director, Bioresearch Monitoring Division (West) at the US Food and Drug Administration, Greater Chicago Area Moderators: Allison Oliva, OCRA Professional Liaison During this presentation, Director Pittman will review...

Medical Devices; Current and Future Challenges

Online Webinar

FDA Operations Update: Topics following the execution of the 2020 Resiliency Roadmap for FDA Inspectional Oversight plan. Remote Regulatory Assessments: Insight into how to manage electronic-based FDA inspections and assessments of medical device quality systems, with the continued use of RRA.   1 CE Contact...

Change is the only Constant – Leading through Uncertainty

Online Webinar

1.5 CE Contact Hour Location: ZOOM Webinar Speaker: Neelu Gibson Moderators: Allison Oliva, OCRA Professional Liaison Synopsis: Change is the only Constant - Leading through Uncertainty The many events of the last two plus years have necessitated employees, business functions and regulators to think and...

$10

Communication Best Practices- Don’t Be Haunted by Your Words

Online Webinar

1.5 CE Contact Hour Location: ZOOM Webinar Speakers: Nancy Singer, JD, LLM, RAC, FRAPS; John Yezeski, Co-Founder, Blue Note Interactive Moderators: Allison Oliva, OCRA Professional Liaison; Courtney Boudreaux, OCRA Social Media Chair Synopsis: Documents are like diamonds. They are very precious. And they last forever....

OCRA Presents: Organizing Chaos

Enterey 200 Spectrum Drive #220, Irvine, CA

-- -- Questions? Contact program@ocra-online.org OCRA’s non-profit Federal Tax ID# 33-0630455 The name used on registration will be used on the certificate

Business of Healthcare

Online

Do you have a novel biotech idea but need help bringing it to market? What regulations may impact your product development? How much money will you need and where to raise it? Which ideas investors fund and why? And finally, how do you convince healthcare providers and patients to use your invention? OCRA has partnered with the Small Business Development Center (SBDC)@UCI Beall Applied Innovation to present a Business of Healthcare event. Local entrepreneurs, investors, marketing strategy experts will share their valuable knowledge and real-life experiences in what it takes to turn an idea into a successful venture. Understand the correlation between risk management, clinical evaluation, and other post market surveillance activities to ensure the necessary linkages and references needed in multiple QMS procedures in order to comply with new Global Regulatory expectations

$10 – $25

IVDR Implementation: Key Considerations Amidst the Looming Deadline

Online

As the IVDR implementation looms closer this program will provide valuable feedback and lessons learned from two thought leaders that are working closely on multi-product IVDR certifications. The program will address most recent developments of IVDR, including a status update about notified bodies and implementation deadlines. We will address possible points of confusion between MDR and IVDR as well as share best practices and pitfalls to avoid.

$10 – $15

Risk Management

Online

Emerging Technologies and Combination products can advance patient therapy by combining and utilizing innovative technologies to deliver treatment. Although these products can be beneficial and lifesaving to the patient, industry may find it difficult to develop and maintain a sound, consistent approach to lifecycle management. Industry is keenly aware that the key to ensuring quality and safety in the lifecycle of a combination product is effective risk management.

$10 – $25

No Finger Sticks! Best News Ever!

Online

U.S. Food and Drug Administration granted Dexcom a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The purpose of this presentation is to share best practices around expanding an indication to include pediatrics. Coupled with providing a simple and effective ecosystem for parents & caregivers meant improved diabetes management for children and reduced finger sticks. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems.

$10 – $25

Tales from the BiMo Files

Online

FDA’s Bioresearch Monitoring (BIMO) Program is a comprehensive system of on-site inspections and data audits designed to monitor all aspects of FDA regulated research; with complicance activities across all 6 of FDA's Centers (CBER, CDER, CDRH, CFSAN, CTP, CVM). BiMo West includes a territory extending from Chicago to Hawaii. This dedicated divison staff conducted over 100 inspections in 2020 alone, including many facilities and laboratories manufacturing new Covid 19 treatments and test kits. Join the expert BiMo West staff and learn about their mission and some of their real life findings in “Tales from the BiMo Files”

$10 – $350

Remote Monitoring and How to Save Cost

Online Webinar

Risk-based monitoring including remote monitoring, is an approach that has been successfully applied now for many years. With increased requirements for conducting post-market clinical follow-up studies and registries, how can monitoring be optimized so you continue to ensure compliance and accuracy of data that will be accepted by the notified bodies or regulators while keeping costs reasonable? Risk-based remote monitoring combined or not with onsite activities and a strong risk management structure, along with well-designed compliant tools can make the whole process much faster and reduce the amount of financial and human resources needed.

$10 – $25

Clinical Evaluation Reports: A dive into the world of CERs and MedDev 2.7/1 Rev 4

Online

Clinical Evidence Reports (CERs) represent a key component to technical files, registration, and compliance in many countries. CERs are meant to provide a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols and instructions for use. All of the supporting clinical evidence should be closely reviewed through a systematic critical appraisal process. The transition to MDR and IVDR in Europe has accelerated the need for up-to-date Clinical Evaluation Reports (CERs) that pass muster with multiple requirements including MedDEv 2.7/1 REV. This applies to every medical device sold in Europe irrespective of the risk classification and experience in the market. In the presentation, we will cover the nuances to meet requirements for the major countries/regions: including Europe’s Notified Bodies, Australia’s TGA, China’s NMPA, Brazil’s ANVISA, and Canada’s Health Canada. We will share about best practices and lessons learned for each of these regulatory reviews. We will also cover the new post-market surveillance requirements required by MDR that affect the CER.

$10 – $25

Clinical Studies in a Virtual World

Online

Our days of weekly travel and on-site visits to provide hands-on product training, study monitoring and case support may be gone forever!   If you want to learn how to plan for the future of virtual clinical studies, join FDA BIMO West Director Eric Pittman, for his presentation on “Decentralized Clinical Trials - What Sponsors and Investigators need to know for successful virtual study planning and execution.”   Learn about FDA’s best practices and guidances for hybrid study design; consent options, remote patient visit and monitoring methodologies, data collection and transfer privacy concerns.  

$10 – $25

OCRA Virtual Networking

Online

OCRA is hosting another Virtual Networking, to help connect fellow OCRA members! Join us on Wednesday, April 21st at 5:30 pm via ZOOM. Come prepared to introduce yourself & network. There will also be a FUN interactive activity to help everyone get to know more about each other!

Invite Others To Join as well!

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

Free

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

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

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

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