Virtual Live event October 6 and 7 8:00AM to 1:00PM US Pacific:
Opportunity for up to 8 continuing education (CE) Credit Units, e.g., RAC, RQAP, RCQ, and other educational CE partner group.
The program will feature renowned industry thought leaders, many of whom are from FDA.
Our two-half day Annual Educational Conference provides industry professionals a cost-effective way to receive training from respected professionals, hear the latest on regulatory trends, and obtain continuing professional education credits (CEUs) to maintain certifications.
Where permission is granted by the speaker, we will provide registered attendees with access to the recorded presentations between Oct 10 and Oct 24.
Panel discussions included.
The program will be hosted through ZOOM Webinars. Please ensure you don’t have limitations (such as corporate restrictions) to access ZOOM webinars. You don’t have to have ZOOM account to participate. ZOOM sign up is free. Test your system, and permissions prior to the meeting.
For all other inquiries contact: [email protected]
Orange County Regulatory Affairs (OCRA) is a non-profit volunteer organization composed of Life Science Regulatory Affairs, Clinical, Quality Assurance, and industry professionals. OCRA offers courses for members interested in expanding their knowledge through educational programs and networking events. OCRA was formed in 1997 and quickly became one of the most vibrant and active non-for-profit, 501 (c) 3 volunteer-led organizations professional organizations in the United States.
• Engineering (software validation and product development),
• Marketing (advertising and labeling),
• Quality (Quality System Regulation, etc.),
• and other related fields.
• Updates from regulators
• Q&A forums with the FDA, networking and opportunities
• Free membership and meeting event door prizes
• Continuing Education Credits opportunities (RAC, RQAC, CE’s)
Is your device Safe and Effective throughout the total life cycle? What could go wrong if the regulations (examples of Design Controls to Production and Process Controls to CAPA) are not properly implemented? How can you do due diligence and prevent future nightmares of device failure, rework, malfunctions, adverse events, and field corrections?
This session will cover considerations for postmarket medication error surveillance, including signal detection, case retrieval, and case evaluation, and discuss postmarket actions to mitigate risk of medication errors.
Are advanced technologies, e.g., Artificial Intelligence and Machine Learning (AI/ML), taking over Pharma, Life Science, the world as we know it? Is it safe to let algorithms make decisions for us, our Subjects in a clinical trial, for doctors prescribing our products to patients, or is it just too risky at present? When will the risks be acceptable to ensure safety and efficacy? How can software be a medical device (SaaMD)? What role will we play as industry experts, or will technology replace us?
In this presentation Steve Thompson will provide answers and predictions for all the above. You may be surprised to hear what they are, and some may be ominous.
Hers’s a glimpse of what will be discussed and how Pharma will be affected:
· AI/ML: Artificial Intelligence / Machine Learning
· Augmented / Virtual Reality
· Edge computing
· Pharma 4.0
The Rise of Telemedicine/Telehealth Due to COVID-19 & Legal Risk Considerations
– the role of FDA in telemedicine enforcement
-risks, especially for providers, including: data privacy, security and electronic exchange; informed patient consent; malpractice; and reimbursements.
The Case for Quality is a program developed under the auspices of the Medical Device Innovation Consortium (MDIC) where various stakeholders, including US FDA and the Medtech industry have partnered to identify practices that lead to higher device quality. The program has been underway for several years and includes the CDRH Case for Quality Voluntary Improvement Program (CFQ VIP), volunteer companies and facilities that undergo periodic assessment focused on practices that advance quality and safety and lead to better outcomes for patients.
Hear from FDA’s leadership about the Case for Quality program. We will discuss current program activities as well as what the future holds for CfQ. Get an agency perspective, including the benefits to companies participating in the program.
Regulatory and quality professionals (RAC, RQAP, ASQ, etc), physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance by completing the final activity evaluation.
To receive up to 8 Credit Units, participants must attest to their attendance. Attendees must attend 85% to 100% of the activity (based on credentialing group requirements). Final conference evaluations must be completed by October 15th.
If you have any questions contact: Rowena Soriano, [email protected]
We will designate 15 registrations for those who are undergoing hardship. Send information with brief message to: Tommi Papson [email protected] addressing the following:
We know that you will leave the conference with gained knowledge, but we also know that sometimes, it’s not up to you to decide if you can attend.
Download our “Make the Case” document to help you justify your attendance at 2020 VISION OCRA’S FDA ANNUAL CONFERENCE. The document has several tips and includes a sample Justification Letter.
If you need specific information about sponsor, sessions or courses, please reach out to Tommi Papson: [email protected]. We’re here to help!Download letter
OCRA is proud to have the expert VidaCher IT Team monitoring this event. If you run into technical issues, please contact us at: [email protected] or (323) 352-7319. Our Troubleshooting Team we be available to help you throughout the webinar.