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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
30 January 2023 — 28 February 2023 $150 Member | $175 NonMember
29 February 2023 — 29 March 2023 $175 Member | $200 NonMember
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.
Anyone interested in the topic, especially regulatory and quality personnel who want to learn more about FDA product approval-related inspections.
Susan ShockeySusan 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.
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A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
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-helpFor 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 firstname.lastname@example.org.