When your company is moving from the Clinical stage to approval of you rfirst commercial product, one of the key milestons is preparing for an FDA Inspection. After you rapplication is submitted for approval, the FDA can plan an inspection at any time. This session will discuss the intent of PAI and BIMO inspection and provide a framework for preparation. We will discuss how to put an Inspection Readiness team together, conducting gap analysis to identify areas for improvment, providing inspection readiness training and conducting mock inspections. Logistics for conducting the inspection, and remediation of findings after the inspection will also be addressed.
REGISTRATION FEES
30 January 2023 — 28 February 2023 $150 Member | $175 NonMember
29 February 2023 — 29 March 2023 $175 Member | $200 NonMember
Learning Objectives
Describe the purpose, intent, and impact of FDA PAI and BIMO Inspections.
Plan and execute inspection readiness activities and training.
Know how to set up rooms, logistics, communications, and roles to support inspection activities.
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?
Regulatory and Quality personnel (as well as anyone else interested) who want to learn more about the requirements and activities needed to prepare for FDA inspections, especially as related to inspections occurring as part of the FDA approval process.
Susan Shockey
Susan Shockey, MS. RAC-US, is a Principal Consultant with Clarkston Consulting. She is a seasoned professional with over 30 years’ industry experience in Quality and 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 space flight and military hardware.
Susan holds a Master of Science in Bioscience Regulatory Affairs from Johns Hopkins University, and a Bachelor of Science in Industrial Engineerig 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.