Greater Niagara: Taking the Fear out of a FDA Inspection

Monday, February 20, 2017, 5:30 PM - 7:30 PM (UTC-5:00) Eastern Time (US & Canada)

Taking the Fear out of a FDA Inspection

Speaker: Glenda Guest

Registration Cost:

  • $0 Chapter Members
  • $5 all other attendees

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 observation
  • Describe characteristics of successful responses to FDA
  • Discuss best responses to FDA Warning Letters

Target Audience: CRC’s, Project Managers, Investigators, Regulatory, Compliance, CRA’s, any other research focused personnel.

Contact hours: 1.0 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.

To receive contact hours: Purchase the contact hours, sign in at the registration desk, 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:
Chapter Members $0
ACRP Members $15
Non-Members $30

Refund Policy: No refunds will be honored unless the program is cancelled by the chapter.

Level: Intermediate

Click here to view event flyer.

Location

Children's Hospital Lung Center
4th Floor Conference Room
140 Hodge Street
Buffalo, NY

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