Preparing for an FDA PAI or BIMO Inspection

When a product moves from the clinical stage to approval phase, preparing for a potential FDA inspection is key. The FDA can plan an inspection at any time. This session will discuss the intent of pre-approval inspections (PAI) and Bioresearch Monitoring Program Information (BIMO) inspections and prep for one. We will cover assembling an inspection readiness team, conducting gap analysis, providing inspection-readiness training, and conducting mock inspections. Inspection logistics and remediation will also be addressed.

REGISTRATION FEES & DEADLINES

30 January 2023 — 28 February 2023  $150 Member | $175 NonMember

29 February 2023 — 29 March 2023  $175 Member | $200 NonMember

Learning Objectives

Audience Learning Level:

Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Who Should Attend?

Anyone interested in the topic, especially regulatory and quality personnel who want to learn more about FDA product approval-related inspections.

Instructors:

Susan Shockey
Susan Shockey, RAC, is a Director with Clarkston Consulting. She is a seasoned professional with more than 30 years’ industry experience in quality/regulatory compliance and project management, including 15 years in pharmaceutical quality systems and regulatory compliance, as well as 15 years in quality-assurance engineering supporting NASA. Shockey has a master’s in bioscience regulatory affairs from Johns Hopkins University, and a bachelor’s in industrial engineering and management from Rensselaer Polytechnic Institute.

Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.