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Tales from the BiMo Files

June 9, 2021 @ 3:00 pm - 4:30 pm

$10 – $350

Educational Opportunity

FDA BiMo West Staff Share Stories from the Field

Will you be ready when the FDA knocks on your door?

What happens when the inspector steps inside?

What mysteries will they uncover?

Moderated Expert FDA Panel and Open Q & A

 

Wednesday, June 9, 2021

3:00-4:30 pm PDT

1.5 Hours Towards Your Continuing Education

Location:  Webinar

 

Synopsis: 

FDA’s Bioresearch Monitoring (BIMO) Program is a comprehensive system of on-site inspections and data audits designed to monitor all aspects of FDA regulated research;  with complicance activities across all 6 of FDA’s Centers (CBER, CDER, CDRH, CFSAN, CTP, CVM).  BiMo West includes a territory extending from Chicago to Hawaii. This dedicated divison staff conducted over 100 inspections in 2020 alone, including many facilities and laboratories manufacturing new Covid 19 treatments and test kits.   Join the expert BiMo West staff and learn about their mission and some of their real life findings in “Tales from the BiMo Files”

*Feel free to email questions ahead of time! program@ocra-online.org

 

Speakers:

 

  • Eric Pittman, Division Director BiMo West
  • Audrey Vigil, Director, Investigations BiMo West
  • Stephen Hansen, Supervisory Investigator
  • Rhonda Loyd –Jones, Bioresearch Monitoring Supervisor

 

     

 

 

 

 

Program Manager: Allison Oliva, RAC, President of Comprehensive Clinical Consulting, OCRA 2021 Secretary

 

Cost:

  • OCRA Members: $25
  • Non-Members: $100, includes 1-year OCRA membership  
  • Government and Student Members: $10, with student/government ID
  • Non-Member Government and Student Rate: $45, includes 1-year OCRA members

 

OCRA Registration Instructions

 

It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.

 

Registration deadline is June 9th.  

OCRA’s non-profit Federal Tax ID# 33-0630455

Cancellation Deadline:

For a refund, please email your cancellation request to OCRA Program Chair (program@ocra-online.org) by June 8, 2021. 

If you have any questions or require additional information, email OCRA Program Chair (program@ocra-online.org). 

Details

Date:
June 9, 2021
Time:
3:00 pm - 4:30 pm
Cost:
$10 – $350
Event Categories:
,
Website:
https://ocra-dg.org/event/the-fda-is-here-bimo-biologics-inspection

Venue

Online

Other

Zoom Webcast
https://zoom.us/j/98187505132