New England: FDA BIMO Compliance and Enforcement of Drugs and Devices (Webinar Replay)

Thursday, October 12, 2017, 12:00 PM - 1:30 PM ET

Webinar Replay: FDA BIMO Compliance and Enforcement of Drugs and Devices

Speaker:
  • David Burrow, PharmD, JD, Acting Director of the Office of Scientific Investigations, Center for Drug Evaluation and Research Office of Compliance, FDA
  • Tamika Allen, MS, RN, Senior Regulatory Operations Officer and Premarket Team Lead, Center for Devices and Radiological Health Division of Bioresearch Monitoring, FDA
Registration Cost: Free for all to attend.

Program Agenda: The pre-recorded webinar will be played via webcast. A group discussion period will immediately follow the conclusion of the webinar.

Program Description: During this webinar program the speakers will review the purpose of the FDA Bioresearch Monitoring (BIMO) program, as well as which entities are inspected under this program. An overview of compliance classifications, and drugs and devices will be compared and contrasted, with emphasis on study design and regulatory requirements. An overview of routine, directed, and for cause inspections will be covered. In addition, speakers will discuss the timing of the inspection process and the records which may be assessed by field inspectors.

Participants should expect to hear about strategies for proactively preparing for site inspections; best practices for responses to FDA 483 letters, with emphasis on rationale for submitting a response and suggestions for writing an effective response; and examples of inadequate and inadequate responses to FDA 483 letters will be provided. Participants will be provided with resources to learn more about BIMO compliance programs.

Upon completion of this Webinar, attendees should be able to:
  • Define the Bioresearch Monitoring program at FDA
  • Identify regulatory differences between CDER/CDRH
  • Recognize best practices for preparing for an FDA Inspection
  • Identify key strategies for responding to Form FDA 483s
Contact hours: 1.0 contact hours have been approved for through ACRP.

To receive contact hours: Purchase the contact hours through ACRP, sign in through the registration link, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost:
  • $0 Chapter Members
  • $15 ACRP Members
  • $30 Non-Members
Target Audience: Open to all Clinical Research Professionals, students interested in Clinical Research

Further Information: Contact Romiya Barry at nec.acrp@gmail.com or call 508.264.0113.

Refund Policy: Contact ACRP member support.

Level: Intermediate
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Contact

Romiya Barry
(508) 264-0113
nec.acrp@gmail.com