Clinical research inspections are critical yet often intimidating. Join us for this webinar to demystify the process by clarifying the purpose and scope, highlighting common regulatory findings, and sharing proven strategies to prepare, respond, and maintain long-term readiness. As a professional in clinical operations, quality assurance, or regulatory affairs, you will gain the insights needed to minimize risks and achieve compliance success under the guidance of a former FDA leader.
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Les inspections en recherche clinique sont essentielles, mais souvent intimidantes. Participez à ce webinaire pour démystifier le processus en clarifiant son objectif et sa portée, en mettant en lumière les constats réglementaires les plus fréquents, et en partageant des stratégies éprouvées pour se préparer, réagir efficacement et maintenir une préparation à long terme. En tant que professionnel(le) des opérations cliniques, de l’assurance qualité ou des affaires réglementaires, vous obtiendrez les connaissances nécessaires pour minimiser les risques et réussir à vous conformer aux exigences, sous la direction d’un ancien dirigeant de la FDA.
Speakers / Conférencieres
Sumatha Kondabolu, Senior Quality Business Partner at Qualio, Moderator
Sumatha Kondabolu brings more than 20 years of experience in the pharmaceutical and medical device industries to the world of small start-ups and scalable quality system implementations. She has built quality management systems for compliance with the FDA QSR, Canada’s medical devices regulations, NIOSH, MDSAP, COFEPRIS, and the EU's MDR, IVDD, and IVDR. She holds a bachelor's in pharmacy, a master's in chemistry, and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 27001, ISO 17025, ISO 9001, and IATF 16949.
Albert Rodriguez is a former FDA employee with over 15 years of experience in medical device regulatory affairs. In addition to his role as a premarket reviewer for cardiovascular devices, he served in the compliance of FDA regulations, specializing in bioresearch monitoring. He has held various roles at the agency, including Team Lead, Assistant Director, and Division Deputy Director. Prior to his FDA career, he also served as a study coordinator and engineer with NASA.
Albert Rodriguez est un ancien employé de la FDA avec plus de 15 ans d’expérience dans le domaine des affaires réglementaires liées aux dispositifs médicaux. En plus de son rôle d’évaluateur de la commercialisation des dispositifs cardiovasculaires, il a travaillé à la conformité aux réglementations de la FDA, en se spécialisant dans la surveillance de la recherche biologique. Il a occupé plusieurs postes au sein de l’agence, notamment chef d’équipe, directeur adjoint et directeur adjoint de division. Avant sa carrière à la FDA, il a également été coordonnateur d’études et ingénieur à la NASA.
Pricing Information
- Members / Guests: $15 CAD ($11 USD)
- Non-Members*: $30 CAD ($22 USD)
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