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About 2021 Vision: OCRA’s FDA ANNUAL CONFERENCE – Exploring Emerging Technologies

Virtual Live event October 5 and 6,  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 presentation slides.

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 5 & 6, 2021


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 attract professionals from all over the world.​​

Why Should You Be There?​

Join Regulatory and QA professionals for:
  • Updates from regulators
  • Forum with the FDA, networking and job 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/BioTech”, “Biological Monitoring Research (BIMO)” and “Emerging Technologies, IoT (Internet of Things), Artificial Intelligence, Data Science, and RWE (Real-World Evidence) and More”
  • Day 1 – Medical Devices

    Track 1 – October 5, 2021

  • Trudy “Tommi” Papson
    08:00 – 08:15
    OCRA Welcome
    By Trudy “Tommi” Papson OCRA 2021 President, Annual Meeting Chair

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

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

  • 09:15 – 10:15

    There are many moving parts in the Medical Device Global Regulatory scene which can effect manufacturers dramatically. Reflect on the importance of coordinating efforts within your company related to changes in global Regulatory Authority requirements to ensure the approval and certification/recertification of your products globally. Hear about some of these important issues:

    • Explore the FDA required process of rulemaking to revise the Quality System regulation to harmonize with ISO 13485:2016
    • Understand where there are similarities and differences in the two QMS requirements
    • Discuss how FDA might use some aspects of MDSAP and where they will likely need to still do their own types of inspections
    • Understand some of the changes in other global Regulatory Authority requirements to ensure the approval and certification/recertification of your products globally


  • Christina Markl Coffey
    10:15 – 10:30
    Networking Sponsor Break
    By Christina Markl Coffey OCRA 2021 Membership Chair – Moderator – Networking Sponsor Break

  • 10:30 – 11:00

    Assistant Commissioner Dan Solis will provide updates to stakeholders on import operations & key initiatives. Topics of discussion to include: covid-19 response, foreign supplier verification program, international mail facilities


  • 11:00-11:30

    This presentation is co-presented with Susan Carino, Principal Consultant at Integrated Project Management Company, Inc.

    Throughout recent history, vaccines represent the most impactful public health advance, helping to prevent the spread of infectious diseases and eliminate some of the most devastating conditions. As communities around the world continue to grapple with the impact of COVID-19, vaccines have come to the forefront as a critical health care tool.

    Much attention has been given to the speed at which biopharmaceutical researchers applied to identify and develop safe and effective vaccines against the coronavirus. The first clinical trial for a potential vaccine identified by a biopharmaceutical company was initiated less than three months after the first reported case.

    Underlying this rapid progress are advances in technology and understanding about the nature of the immune system, which have allowed us to more rapidly respond to the current pandemic compared to the past. This session will highlight the top advances for vaccine development, describe the regulatory environment, and explain how vaccines work with the body to confer immunity.


  • 11:30 – 12:30

    This presentation will review the key takeaways from the Resiliency Roadmap for FDA Inspectional Oversight, focusing on the impact to medical device inspections during the COVID-19 pandemic, and will include metrics on inspections conducted and the plan going forward for prioritizing device inspections. The FDA leveraged available tools during the pandemic and implemented new approaches to conduct inspections, including Remote Regulatory Assessments of medical device firms. The presentation will explain RRAs and provide an update on the number of RRAs conducted thus far. Lastly, the presenter will discuss and demonstrate publicly available tools that can be used to retrieve, download, and analyze FDA data, including inspections, 483 Observations, compliance cases, and recall information. Inspection data and Top 483 Observations from 2015 – 2021 will be discussed, and a live demonstration of the Dashboard will be provided.


  • 12:30 – 1:00

    Virtual FDA Town Hall, (all speakers invited)


  • Day 1 – Pharma/BioTech

    Track 2 – October 5, 2021

  • Trudy “Tommi” Papson
    08:00 – 08:15
    OCRA Welcome
    By Trudy “Tommi” Papson OCRA 2021 President, Annual Meeting Chair

  • 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
    Keynote Speaker
    By Alonza Cruse Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs (ORA), Silver Springs, MD, US FDA

  • 09:15 – 10:15

    This presentation is co-presented with Angela Bezigos, CEO, Touchstone Technologies, Inc.

    Gene therapy is an experimental technique to treat or prevent disease. In the future, this technique may allow doctors to treat a disorder by inserting a gene into a patient’s cells instead of relying on drugs or surgery. Several approaches to gene therapy include:
    • Replacing a mutated gene that causes disease with a healthy copy of the gene
    • Inactivating, or “knocking out,” a mutated gene that is functioning improperly
    • Introducing a new gene into the body to help fight a disease

    Although gene therapy is a promising treatment option for diseases including selected inherited disorders, cancers, and viral infections, safety and effectiveness remain a concern. Gene therapy is currently being tested for diseases that have no other cures.

    This session will describe the regulatory requirements for gene therapy, how genetic information is transferred into target cells, the significance of vectors and how the latest technologies such as genetic engineering, recombinant DNA technique and mRNA technology can be utilized to improve performance of gene therapy in the treatment of disease.


  • Christina Markl Coffey
    10:15 – 10:30
    Networking Sponsor Break
    By Christina Markl Coffey OCRA 2021 Membership Chair – Moderator – Networking Sponsor Break

  • James Wabby
    10:30 – 11:00
    Session 2: Emerging Technologies on the Horizon
    By James Wabby Executive Director, Head of Global Regulatory Affairs, Emerging Technologies and Combination Products at AbbVie

  • James Wabby
    11:00-11:30
    Session 2: Emerging Technologies on the Horizon (continued)
    By James Wabby Executive Director, Head of Global Regulatory Affairs, Emerging Technologies and Combination Products at AbbVie

  • 11:30 – 12:30

    Objectives:
    • Describe major pharmacy compounding adverse events which led to the birth of Drug Quality and Security Act (DQSA)
    • Discuss 503A and 503B regulations as they relate to human drug compounding
    • Compare and contrast 503A and 503B regulations as they relate to expanded pharmacist training and practice


  • 12:30 – 1:00

    Virtual FDA Town Hall, (all speakers invited)


  • Day 2 – BIMO – Bioresearch Monitoring

    Track 3 – October 6, 2021

  • Susan Bain
    08:00 – 08:15
    OCRA Welcome
    By Susan Bain OCRA 2021 President Elect – Moderator – Medical Devices – Track 1

  • 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
    Keynote Speaker: Resiliency Roadmap, FDA During the COVID-19 Pandemic
    By Eric Pittman Program Division Director Bioresearch Monitoring Program Division II (BIMO-W) Chicago, IL US FDA

  • 09:15 – 10:15

    Decentralized Clinical Trials (DCTs) refer to clinical trials using digital technologies to have remote interactions with real participants. In this presentation, we will discuss the definition and various components of decentralized clinical trials (DCTs), the relevant regulations, benefits and challenges of DCTs, points to consider in oversight and execution of DCTs, and the current available guidance.


  • Christina Markl Coffey
    10:15 – 10:30
    Networking Sponsor Break
    By Christina Markl Coffey OCRA 2021 Membership Chair – Moderator – Networking Sponsor Break

  • Jamie Colgin
    10:30 – 11:30
    Session 2: Data Integrity
    By Jamie Colgin President, Colgin Consulting

  • 11:30 – 12:30

    This presentation will cover the use of Metadata in Clinical Trials. The presentation will start by defining Metadata and discuss ways in which Metadata is used. Using real world examples this presentation will cover the power of Metadata to identify issues with source data, concerns when Metadata is incomplete, and discuss ways that Metadata is reviewed during FDA inspections.


  • 12:30 – 1:00

    Virtual FDA Town Hall (all speakers invited) Chrissy Cochran, Ph.D., Director, FDA-Office of Bioresearch Monitoring Operations, Eric Pittman, FDA-Program Division Director, OBIMO W,
    FDA Office of Enforcement and Import Operations


  • Day 2 – Emerging Technologies: What’s New on the Horizon

    Track 4 – October 6, 2021

  • Susan Bain
    08:00 – 08:15
    OCRA Welcome
    By Susan Bain OCRA 2021 President Elect – Moderator – Medical Devices – Track 1

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

  • Eric Pittman Eric Pittman - FDA
    08:15 – 09:15
    Keynote Speaker: Resiliency Roadmap, FDA During the COVID-19 Pandemic
    By Eric Pittman Program Division Director Bioresearch Monitoring Program Division II (BIMO-W) Chicago, IL US FDA

  • 09:15 – 10:15

    Wearables and handheld devices (watches, glasses, smartphones, etc.) can track everything about you. Software is becoming a medical device more-and-more with Artificial Intelligence and Machine Learning. The Internet of Things (IoT) is connecting everything. Is this safe? What if your personal and private information gets into the wrong hands? What if there’s a breach? Although technologies show promise, they also raise risk; ;in fact, technology outpaces ethics. How do we leverage technology without sacrificing ourselves? This presentation will discuss the exciting new technologies, the risks, how we can protect ourselves, our data, and move forward cautiously with safety at the forefront.


  • Christina Markl Coffey
    10:15 – 10:30
    Networking Sponsor Break
    By Christina Markl Coffey OCRA 2021 Membership Chair – Moderator – Networking Sponsor Break

  • 10:30 – 11:30

    In 2005, then FDA Commissioner Dr. Janet Woodcock articulated USFDA’s vision for 21st century pharmaceutical manufacturing as “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.” Since then, giant strides in manufacturing technology and control system architectures to include Pharma 4.0, S88, S95, ERP systems have reliably served as enablers for advanced manufacturing.
    In order to sustain the therapies for the personalized medicine era, evolving automated process control system technologies and architectures serve as enablers of adaptive manufacturing. It requires smaller batch sizes with frequent switchovers that should be timely and cost-effective.
    Manufacturing of life science products being the lifeblood of life sciences industry, the presentation will enumerate manufacturing control software design leveraging evolving software technologies and computing architectures in life sciences manufacturing. Such a design also facilitates the integration of manufacturing and business functions across several control IT platforms. Highlighted will be the use of Pharma 4.0 architecture, S88 and S95 software modular design standards and CSA validation methodology to realize “Validation by Design”.


  • 11:30 – 12:30

    2020 helped change the perception of pediatric health and technology and resulted in innumerable breakthroughs and innovations across various fields. This is the right time for a big push in pediatric data science, innovation, medical devices, and technology. Not only could pediatric medical devices, data sets, and systems fill gaps in-hospital care, but they also help monitor children’s health and keep them out of the hospital in the first place. Dr. Terence Sanger, MD, Ph.D. will discuss why pediatric innovation has lagged that of adults, how to identify and implement technologies that significantly improve pediatric care and are most viable for clinical use and commercialization and why data science and Real-World Evidence (RWE) is important for regulatory decision-making and cutting-edge insights


  • 12:30 – 1:00

    Virtual FDA Town Hall (all speakers invited) Chrissy Cochran, Ph.D., Director, FDA-Office of Bioresearch Monitoring Operations, Eric Pittman, FDA-Program Division Director, OBIMO W,
    FDA Office of Enforcement and Import Operations


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Keynote Speaker

Track 1 – Medical Devices

Track 2 – Pharma/BioTech

Track 3 – BIMO – Bioresearch Monitoring

Track 4 – Emerging Technologies: What’s New on the Horizon

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Our Sponsors

For those interested in sponsoring this event. We have Gold, Silver and Bronze sponsorships available.
Please reach out to: Piet Lesage: professional_liaison@ocra-online.org.

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 2021 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

If you run into technical issues, please contact us at: IT@ocra-online.org. Our Troubleshooting Team we be available to help you throughout the webinar.

Register Today

To REGISTER for this Event, please click HERE. You will be taken to The 2021 OCRA Annual Event Eventbrite Registration page.

  • 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
  • $60
  • 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
  • $25
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OCRA Board Of Directors