Get Fda Audit Preparation Resource Amp Checklist - Ictr - Ictr Johnshopkins

The FDA Audit Preparation Resource Amp Checklist is a critical tool designed to assist clinical investigators in preparing for FDA audits. This guide provides a step-by-step approach to effectively fill out the checklist online, ensuring you meet all necessary requirements and compliance standards.

Follow the steps to complete the checklist with confidence.

1. Press the ‘Get Form’ button to obtain the checklist and open it in your document editor.
2. Begin by filling in the initial contact information section, providing the name of the staff member who received the initial FDA contact, the date of contact, and any relevant FDA inspection visit information such as the estimated time of arrival.
3. Complete the 'Purpose of Inspection' section, specifying the clinical trial(s) involved, the principal investigator, and type of inspection (routine, directed, or follow-up).
4. Identify all personnel and documents requested by the FDA and confirm their availability for the audit date. Ensure that all relevant documents are prepared for inspection.
5. Designate an 'Inspection Coordinator' and an escort to assist the FDA inspectors during their visit. Ensure log entries are maintained for the entire inspection process.
6. Confirm that all study-related materials and documents are organized and accurately compiled in accordance with the checklist. This includes protocols, IRB approval documentation, and informed consent forms.
7. Review and finalize all sections to ensure completeness and accuracy, documenting any comments or additional notes in your copy.
8. Once complete, the document can be saved for future reference, or you can download, print, or share the completed checklist as needed.

Take action now by completing your FDA Audit Preparation Resource Amp Checklist online to ensure compliance.