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Tuesday, June 29 • 10:00am - 11:00am
#218 SL: Novel and Innovative Approaches to Inspections: Verification of Quality and Compliance Using Remote Methodologies and New Technology

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-567-L04-P; CME 1.00; IACET 1.00; RN 1.00

Regulators have a duty to oversee compliance with national and international regulations, which is often allied to supporting and encouraging innovation and ensuring regulatory burden on industry is appropriate. The inspection universe continues to grow, and the complexity of operations has increased with the adoption of new technologies and an increasing number of novel approaches to the development of medicines. As a result new and innovative approaches to inspections have to be developed. Sole reliance on physical inspections is becoming increasingly outdated and is often not the most effective use of resource for the Regulator or Industry. The development of inspection activities which are flexible, risk focused and do not put unnecessary burden on industry is an important consideration. Central to this aim is the development of remote inspection strategies and record sharing approaches that benefit the regulator and Industry alike. This session will explore these new approaches from a regulatory and industry perspective.

Learning Objectives

Explore novel methodologies for performing regulatory inspections that provide benefits to both Regulators and Industry, whilst ensuring the safety and quality of medicines; Assess the advantages and disadvantages of new inspection models from both sides of the fence with a focus on oversight, efficiency, and cost saving; Analyze and trial the use of new and established technologies to aid the conduct of remote inspections.

Chair

Paula Walker, MA

Speaker

Novel and Flexible Approaches to Monitoring Regulatory Compliance Across the GXP Environment: MHRA Perspective
Paula Walker, MA

Panelist
Lesley Graham

Panelist
Hiromichi Isaka, MPharm



Speakers
avatar for Lesley Graham

Lesley Graham

Director, Expert Auditor, AstraZeneca, United Kingdom
Lesley joined AstraZeneca’s Research & Development Organisation in 2019. She is responsible for the Global Inspection Process covering GCP, GLP and GVP inspections. She also leads the QA Regulatory Intelligence activity. Before joining AstraZeneca Lesley spent 17 years at the UK’s... Read More →
avatar for Hiromichi Isaka

Hiromichi Isaka

Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Hiromichi Isaka is Inspector of office of Non-clinical and Clinical Compliance Pharmaceuticals and Medical Divice Agency(PMDA). Mr. Isaka engages in document-based inspection to assess whether the submitted data comply with the data integrity standards for regulatory submission... Read More →
avatar for Paula Walker

Paula Walker

Head of Compliance (GCP, GPvP, GLP & GxP Expert Circle), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Head of Compliance (1) responsible for the GCP, GPvP, GLP inspections teams and GxP Expert Circle... Read More →


Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Forum