About 2020 Vision: OCRA’s FDA ANNUAL CONFERENCE

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.

Webinar Details:

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: Annual_meeting@ocra-online.org

WHERE
Online
ZOOM Conference

WHEN
Tuesday to Wednesday
October 6 & 7, 2020

View Speakers


Facts About OCRA​

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.

Who Should Attend

All professionals associated with health and life science fields.​
Our focus is regulatory in nature; however, the presentations will also provide valuable information for individuals involved in:​

• Engineering (software validation and product development),

• Clinical,

• Marketing (advertising and labeling),

• Quality (Quality System Regulation, etc.),

• and other related fields.

The program is designed to attracted professionals from all over the world.​​

Why Should You Be There?​

Join Regulatory and QA professionals for:

• 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)


Conference Schedule

This conference will have 4 Tracks
Medical Devices, Pharma, Biological Monitoring Research (BIMO), and Biologics – Compliance – Dietary Supplements

  • Day 1 – Medical Devices

    Track 1 – October 6, 2020

  • Luis Jimenez
    08:00 – 08:15
    OCRA Welcome
    By Luis Jimenez OCRA 2021 Past-President

  • Christina Markl Coffey
    08:15 – 12:30
    Moderator
    By Christina Markl Coffey OCRA 2021 Membership Chair – Moderator – Networking Sponsor Break

  • Shari Shambaugh Shari Shambaugh - FDA
    08:15 – 09:15
    Medical Device Keynote
    By Shari Shambaugh Program Division Director (PDD), Office of Medical Device and Radiological Health Operations (OMDRHO) Division 3 – West, Dallas, TX US FDA

  • Kim Trautman
    09:15 – 10:15
    What’s Up with ISO 13485, FDA’s QS regulation & EU CEN/TR 17223?
    By Kim Trautman Medical Device, IVD, and Combination Product Regulatory & Quality Expert

  • 10:15 – 10:30
    Break – Optional: Networking, and OCRA Prizes Session

  • 10:30 – 11:30

    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?


  • Christopher Mauch
    11:30 – 12:30
    EU MDR is (almost) here: Now what?
    By Christopher Mauch Manager, Life Science Advisory – KPMG, LLP

  • 2020 VISION OCRA’S FDA ANNUAL CONFERENCE
    12:30 – 1:00
    FDA Town Hall

  • Day 1 – Pharma

    Track 2 – October 6, 2020

  • Luis Jimenez
    08:00 – 08:15
    OCRA Welcome
    By Luis Jimenez OCRA 2021 Past-President

  • Susan Bain
    08:15 – 12:30
    Moderator
    By Susan Bain OCRA 2021 President Elect – Moderator – Medical Devices – Track 1

  • Alonza Cruse Alonza Cruse - FDA
    08:15 – 09:15
    Pharma Keynote
    By Alonza Cruse Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs (ORA), Silver Springs, MD, US FDA

  • 09:15 – 10:15

    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.

    • Describe general principles of medication error reporting and analysis
    • Discuss assessment of reports to determine type of medication error, root cause, and contributing factors
    • List examples of postmarket medication errors

  • 10:15 – 10:30
    Break – Optional: Networking, and OCRA Prizes Session

  • 10:30 – 11:30

    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
    · Blockchain
    · Edge computing
    · IoT
    · Pharma 4.0
    · Robots


  • Angela Bazigos
    11:30 – 12:30
    Come Into My Parlor: A Close Up Look Into Counterfeit Drugs.
    By Angela Bazigos CEO, Touchstone Technologies, Inc

  • 2020 VISION OCRA’S FDA ANNUAL CONFERENCE
    12:30 – 1:00
    FDA Town Hall

  • Day 2 – BIMO

    Track 3 – October 7, 2020

  • Luis Jimenez
    08:00 – 08:15
    OCRA Welcome
    By Luis Jimenez OCRA 2021 Past-President

  • Allison Oliva
    08:15 – 12:30
    Moderator
    By Allison Oliva OCRA 2021 Secretary – Moderator – BIMO – Track 3

  • Eric Pittman Eric Pittman - FDA
    08:15 – 09:15
    BIMO Compliance Update-Unique in the Scope of its Compliance Programs and Regulations Shared by All Six of FDA’s Centers (CBER, CDER, CDRH, CFSAN, CTP, CVM)
    By Eric Pittman Program Division Director Bioresearch Monitoring Program Division II (BIMO-W) Chicago, IL US FDA

  • Audrey Vigil Audrey Vigil - FDA
    09:15 – 10:15
    Data Integrity and Bioresearch Monitoring: Building Quality into The System
    By Audrey Vigil Director, Investigations for BIMO-West, Denver CO USFDA

  • 10:15 – 10:30
    Break – Optional: Networking, and OCRA Prizes Session

  • L’Oreal Walker L’Oreal Walker - FDA
    10:30 – 11:30
    Nothing Went As Planned: Resiliency in Regulatory Affairs
    By L’Oreal Walker Supervisory Consumer Safety Officer for BIMO-West, Detroit, MI US FDA

  • Eric Pittman Eric Pittman - FDA
    11:30 – 12:30
    Knock-Knock ! The FDA is Here.
    By Eric Pittman Program Division Director Bioresearch Monitoring Program Division II (BIMO-W) Chicago, IL US FDA

  • 2020 VISION OCRA’S FDA ANNUAL CONFERENCE
    12:30 – 1:00
    FDA Town Hall

  • Day 2 – BCDS

    Track 4 – October 7, 2020

  • Luis Jimenez
    08:00 – 08:15
    OCRA Welcome
    By Luis Jimenez OCRA 2021 Past-President

  • Rowena Soriano
    08:15 – 12:30
    Moderator
    By Rowena Soriano OCRA 2021 Program Chair – Moderator – Pharma/BioTech – Track 2

  • Susan Turcovski Susan Turcovski - FDA
    08:15 – 09:15
    Biologics Update
    By Susan Turcovski Deputy Director, Office of Biological Products Operations Office of Regulatory Affairs 
U.S. Food and Drug Administration

  • Rochelle R. Blair Rochelle R. Blair - FDA
    09:15 – 10:15
    Compliance with Dietary Supplement Regulations
    By Rochelle R. Blair Compliance Officer, Office of Human and Animal Foods, Human and Animal Food West V Compliance Branch, Div. of Human and Animal Food Ops. West V
 Office of Human and Animal Food Operations
 U.S. FDA

  • 10:15 – 10:30
    Break – Optional: Networking, and OCRA Prizes Session

  • 10:30 – 11:30

    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.


  • 11:30 – 12:30

    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.


  • 2020 VISION OCRA’S FDA ANNUAL CONFERENCE
    12:30 – 1:00
    FDA Town Hall

Keynote Speakers

Track 1

Track 2

Track 3

Track 4

OCRA Board Of Directors

Our Sponsors

For those interested in sponsoring this event. We have Gold, Silver and Platinum sponsorships available.
Please reach out to: Piet Lesage: professional_liaison@ocra-online.org.
PharmaLex
Valgenesis
Integrated Project Management Company
Brandwood CKC
UCI Division of Continuing Education
Azuza Pacific University: MS Biotechnology
Qarad
Rimsys

Continuing Education Units

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, CE@ocra-online.org

Scholarship info

We will designate 15 registrations for those who are undergoing hardship. Send information with brief message to: Tommi Papson annual_meeting@ocra-online.org addressing the following:

  1. How long have you been a member (and if currently an active member)
  2. Current Issues being faced (unemployment, furloughed, loss of scholarship, impacted by pandemic, ect.)
  3. Express your personal perceived value of participating in the conference

Make the Case (downloadable letter)

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: Annual_Meeting@ocra-online.org. We’re here to help!

Download letter

IT Support

OCRA is proud to have the expert VidaCher IT Team monitoring this event. If you run into technical issues, please contact us at: IT@ocra-online.org or (323) 352-7319. Our Troubleshooting Team we be available to help you throughout the webinar.

Register Today

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  • 1-Day Conference Pass

    ACCESS TO ONE DAY OF THE CONFERENCE
  • Participate Live
  • Eligible for prizes
  • Access to presentations and recordings
  • Eligible for up to 4 CE Credits
Recommended

  • Full Conference Pass

    ACCESS TO BOTH DAYS OF THE CONFERENCE
  • Participate Live
  • Eligible for prizes
  • Access to presentations and recordings
  • Eligible for up to 8 CE Credits

  • Student & Government Pass

    ACCESS TO BOTH DAYS OF THE CONFERENCE
  • Participate Live
  • Eligible for prizes
  • Access to presentations and recordings
  • Eligible for up to 8 CE Credits