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Monday, June 24 • 3:30pm - 4:30pm
#164: Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-561-L04-P; CME 1.00; IACET 1.00; RN 1.00

The importance of periodic screenings (e.g. assessments, mock inspections) to ensure good inspection health. An interactive and colorful discussion of how being prepared by getting a thorough ‘check-up’ is the best way to be ready for an inspection.

Learning Objectives

Demonstrate how periodic screenings are an important part of inspection readiness; Discuss where hidden challenges lurk and how mock inspections can bring these items to light; Identify appropriate remediation plans that are organizationally focused and not study specific.

Chair

Grace M Crawford, MS

Speaker

Panelist
Barbara Maley

Panelist
Lauren Blomberg

Panelist
Gina C Lucas

Panelist
Matthew Krumrai


Speakers
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality and Compliance, AstraZeneca
Grace joined MedImmune in April 2015 to lead the Clinical Quality & Compliance function. Prior to joining MedImmune, Grace spent over 21 years at ICON where her main focus was leading the Clinical QA Department. She is active in industry participating in forums such as the Society... Read More →
avatar for Barbara Maley

Barbara Maley

Sr. Consultant, The Avoca Group
Barb Maley is a Quality Assurance professional with 29 years of research experience including 26 years within the pharmaceutical industry (GLP and GCP) and 17 years hands-on experience within Quality Assurance and Continuous Improvement. Barb has extensive experience providing quality... Read More →
LB

Lauren Blomberg

GCP Inspection Lead, Quality and Continuous Improvement, GCTO, Merck & Co., Inc.
Lauren Blomberg is an Associate Director, GCP Inspection Lead within the Global Clinical Trial Operations department at Merck & Co., Inc. Lauren has over 10 years of GCP and PV experience in the pharmaceutical industry, with expertise in Inspection Preparation and Inspection Management... Read More →
avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →
GL

Gina Lucas

Director, Strategic Advice, AstraZeneca Pharmaceuticals LP
Gina Lucas is a professional with over 25 years of GXP QA pharmaceutical industry experience. Her current role includes providing GCP strategic direction for Immuno-oncology programs at AstraZeneca including providing quality and compliance advice during study conduct, submission... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Forum