The FDA BIMO inspection is a well-established part of the FDA preapproval process for medicines, medical devices, food and color additives, veterinary products and tobacco products. The BIMO inspection is administered under the FDA Compliance Program, specifically, as part of program 7348.811 for Clinical Investigators and Sponsor Investigators. BIMO inspections can be performed at any point during a clinical study or as part of broader evaluation associated with the New Drug Application (NDA) process. Drug Safety preparation for the BIMO inspection will contribute to the overall successful NDA approval for an organization.

This course will provide attendees with a general understanding the BIMO inspection, the impact on Drug Safety and how to effectively prepare for, participate in and respond to the BIMO inspection from a Drug Safety perspective.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass a final exam. Upon completion of the exam, CEU certificates will be provided.

Learning Objectives

• Understand the BIMO inspection in relation to the scope of the NDA
• Explain what being inspection ready means
• Understand how to effectively prepare your Drug Safety team for the BIMO inspection
• Identify how to effectively plan for a BIMO inspection
• Planning for gaps that will come up during a BIMO inspection
• Understand how to interface with the BIMO inspector
• Determine how to respond to BIMO inspection findings
• Understand how to continue effective inspection readiness following the BIMO inspection

Course Outline

• Module 1: The BIMO Inspection explained and understanding why they are performed
• Module 2: The scope of the BIMO inspection in relation to your company
• Module 3: Preparing for the BIMO inspection
• Module 4: Participating in the BIMO inspection
• Module 5: Responding to Drug Safety observations identified during the BIMO inspection
• Module 6: Maintaining inspection readiness following the BIMO inspection

Who Should Attend

• Heads of Drug Safety Departments
• Heads of Drug Safety Operations
• Clinical Operations Personnel
• Quality Assurance Personnel
• Other Personnel that would participate in the BIMO inspection

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

Heather Murphy, R.N., M.B.A., CQA

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Course Length and Time

2 weeks for 4 hours each week.

Registration Fees

$1,695 by Early Bird Deadline

$1,895 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 8 hours (0.8 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-059-L99-P. Released: 9/25. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.