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Wednesday, June 22 • 11:00am - 12:00pm
#323: Remote GMP Assessments, Inspections and Audits : Here to Stay?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-617-L04-P ; CME 1.00; RN 1.00

This session will discuss how regulators and industry have approached remote evaluation of manufacturing facilities during the COVID pandemic and provide insight into supportive tools, technology and approaches.

Learning Objectives

Describe different health authority approaches to on-site inspection alternatives during COVID; Discuss technology tools to assist in remote evaluations of manufacturing facilities.

Chair

Peter Godlewski, MS

Speaker

FDA Update
Alonza Cruse

Industry Update
Michele Piepoli

ANVISA Update
Liana Tieko Evangelista Kusano Fonseca, MHS



Speakers
avatar for Alonza Cruse

Alonza Cruse

Director, Office of Pharmaceutical Quality Operations, ORA, OGROP, FDA, United States
Director, Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs (ORA), responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic, working in conjunction with FDA Centers: CDER and CVM. Alonza is also leading... Read More →
LK

Liana Kusano Fonseca

Manager, Office of Inspections and Law Enforcement for Drug Products and APIs, Brazilian Health Regulatory Agency (ANVISA), Brazil
Master in Medical Sciences from University of Brasilia, Specialist in Sanitary Regulation and Surveillance from Oswaldo Cruz Foundation, leader inspector of medicines since 2012 and Manager of Office of Inspections and Law Enforcement for Drug Products and APIs at Brazilian Health... Read More →
PG

Peter Godlewski

Associate Vice President, Quality Compliance, Organon & Co., Switzerland
Pete Godlewski is currently the Head of Global Quality Compliance within Organon. His team responsible for GMP audit & compliance, regulatory policy evaluation, core quality management systems and quality business processes as well as technology enablement as Organon has emerged within... Read More →
MP

Michele Piepoli

Senior Quality Consultant, M H P Consulting LLC, United States


Wednesday June 22, 2022 11:00am - 12:00pm CDT
Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  10: RegCMC-Product Quality, Forum