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  • Program Chapter 48 Bioresearch Monitoring 7348.808a ... - Fda

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FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7348.808A Chapter 48 Bioresearch Monitoring Subject Implementation Date GOOD LABORATORY PRACTICE PROGRAM (Nonclinical Laboratories).

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How to fill out the PROGRAM Chapter 48 Bioresearch Monitoring 7348.808A online

This guide provides a comprehensive overview of how to complete the PROGRAM Chapter 48 Bioresearch Monitoring form 7348.808A. It is designed to assist users of all backgrounds in ensuring accurate and efficient submission of the required information.

Follow the steps to successfully complete the form online.

  1. Click the ‘Get Form’ button to access the form and open it in the online editor.
  2. Carefully read the instructions provided at the beginning of the form. This section outlines essential guidelines that will aid in completing the document accurately.
  3. Proceed to fill in your details in the designated fields. Make sure to include all relevant information, such as data about the laboratories to be inspected and the types of inspections required.
  4. In the data reporting section, list all compliance-related activities, ensuring that you follow the specific requirements laid out by both the FDA and EPA standards.
  5. Review the inspectional procedures outlined in the form and provide the necessary verification information.
  6. Once all sections have been completed, thoroughly verify the accuracy of your entries to avoid any potential issues. It may be helpful to have another person review the form.
  7. After confirming all entries are correct, save the changes, and then download or print the form as needed for your records.
  8. Finally, share the completed form with the necessary authorities or stakeholders as dictated by the program requirements.

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FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research.

BIMO stands for Bioresearch Monitoring, a program of on-site inspection and data audits to monitor all aspects of conduct and reporting of the US Food and Drug Administration (FDA)-regulated research. The program was established in 1977 after a need was identified to audit clinical research sites.

FDA Form 482 - Notice of Inspection: It is an official notice of FDA for inspection signed by the FDA officials. It is produced by the inspector and has the authority to inspect the manufacturing facility.

FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research.

The FDA Bioresearch Monitoring Program (BIMO) develops guidelines for inspections of clinical investigators, sponsors, and Institutional Review Boards (IRBs).

FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant.

There are 2 basic types of FDA inspections: Surveillance inspection - is routine FDA inspection, whereas the compliance inspection is based on specific objective, such as compliant or other suspected specific problem like unreported Adverse Events (AEs).

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232