Taking the Fear Out of an FDA Inspection (Webinar Replay)
Program Agenda: 11:00 am ET & 5:00 pm ET – Webinar Replays
*Note: The same webinar will be played at both times.Registration Cost:
- $2 for Chapter Members
- $5 ACRP Members
- $7 Non-Members
Contact Hour Cost: FREE for Chapter Members
$15 ACRP Members
$30 Non-Members
Refund Policy: Refunds will only be processed if the event is canceled by the chapter
Program Description: Do you understand the process and related outcomes of an FDA Clinical Investigator Inspection? Do you understand the various documents and possible outcomes – EIR, 483, Untitled Letter, NAI, VAI, OAI and NIDPOE? How can your team best prepare and respond? We will review the documents exchanged during an inspection and the process followed by FDA to determine whether a warning letter will be issued. We will identify and define the possible outcomes of an inspection. Using Warning Letters we will evaluate FDA’s assessment of Clinical Investigator responses and discuss strategies for successfully addressing FDA’s observations to avoid further sanctions. Participants will receive a template letter suitable for customization and response to a 483 or Warning Letter as well as the FDA’s own manual guiding the conduct of Clinical Investigator inspections.
Upon completion of this Webinar, attendees should be able to:
- Identify FDA forms and documents related to an FDA site inspection
- Apply strategies for developing successful responses to FDA’s inspectional observations
- Describe characteristics of successful responses to FDA
- Discuss best responses to FDA Warning Letters
Speaker Glenda Guest, VP of Norwich Clinical Research Associates Ltd. (NCRA), has an extensive background in the clinical research industry having worked as a monitor, project manager, data management coordinator, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession in 1997.
REGISTRATION REQUIREMENTS: Registration via ACRP is required in order to obtain CEUs.
Level: All audiences