Events

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.

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.

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.

 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).

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.

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.

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!

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.