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.

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

Secret Ways to Break into Regulatory Affairs

Online

Secret Ways to Break into Regulatory Affairs Webinar 1.5 Hours Towards Your RAC Recertification September 17th, 2020 6:00pm - 7:30pm   Location: Webinar Program Manager: Rowena Soriano Speakers: Susan Bain and Eri Hirumi Cost: Free to all but need to register.   Come and join us...

Free

Biocompatibility: ISO 10993-2018- What’s Different?

Online

Standards are constantly changing. ISO 10993 is one of them. Do you know what the latest 2018 version contains? What are the new requirements? How can you implement testing efficiently without undue cost but ensure smooth reviews by the FDA and EU Notified Bodies. How do you address requests for additional testing? Come and hear how the FDA is handling this and what you can expect. Forewarned is being Forearmed.

$10 – $25

Legal and Compliance Hot Topics: “CATCH ME IF YOU CAN”

Online

Fifth Forum topic: ""Clinical Investigator" Found Guilty of Committing Fraud in Clinical Research Trials" . Hear about this fascinating case of how a man, posing as a physician, conned regulators and hundreds of people by conducting clinical trials on the unsuspecting public and pharmaceutical companies. Was he cavalier enough to escape? “Catch me if you can”.

Free

Audits, Inspections, & Warning Letters – Best Practices

Online

With FDA inspections, MDSAP audits, and ISO audits, the challenges of responding appropriately to the agency or ISO registrar are a constant balancing act for all medical product manufacturers. The key is addressing observations and compliance issues quickly and comprehensively. This program will present best practices for managing these compliance pitfalls and current FDA Warning Letter trends and perspectives on industry best practices. A panel consisting of FDA and industry representatives will provide insight on best practices in providing responses to FDA and ISO registrars and avoiding enforcement actions. Come spend the evening with us and build your confidence in interacting with the FDA and ISO registrars during an inspection/audit and in writing effective responses.

$20 – $55

Challenges to be Encountered while conducting FDA Remote Inspections in the Post COVID Era

Online

With FDA inspections, MDSAP audits, and ISO audits, the challenges of responding appropriately to the agency or ISO registrar are a constant balancing act for all medical product manufacturers. The key is addressing observations and compliance issues quickly and comprehensively. This program will present best practices for managing these compliance pitfalls and current FDA Warning Letter trends and perspectives on industry best practices. A panel consisting of FDA and industry representatives will provide insight on best practices in providing responses to FDA and ISO registrars and avoiding enforcement actions. Come spend the evening with us and build your confidence in interacting with the FDA and ISO registrars during an inspection/audit and in writing effective responses.

$10 – $25

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

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

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

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

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).

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

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

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

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

CA’s CCPA & EU’s GDPR – Part 2

Online

The California Consumer Privacy Act (CCPA) creates new consumer rights relating to the access to, deletion of, and sharing of personal information that is collected by businesses.

Alphabet Soup of Regulations

Online

Professor Virginia A. Suveiu, Esq., counsels on regulatory compliance and commercial law matters. She is currently editing a handbook on Risk Management and the Law for Routledge.

California Consumer Privacy Act Overview

Online

The California Consumer Privacy Act (CCPA) creates new consumer rights relating to the access to, deletion of, and sharing of personal information that is collected by businesses.