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Novel and Innovative Approaches to Inspections: Verification of Quality and Compliance Using Remote Methodologies and New Technology
Session Chair(s)
Paula Walker, MA
Global Head of Risk Based Quality Management
Roche Products Ltd., United Kingdom
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 Sole reliance on physical inspections is becoming increasingly outdated and is often not the most effective use of resource for the Regulator or Industry.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 Objective : 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.
Speaker(s)
Novel and Flexible Approaches to Monitoring Regulatory Compliance Across the GXP Environment: MHRA Perspective
Paula Walker, MA
Roche Products Ltd., United Kingdom
Global Head of Risk Based Quality Management
Panelist
Lesley Graham
AstraZeneca, United Kingdom
Director, Expert Auditor
Panelist
Hiromichi Isaka, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Non-clinical and Clinical Compliance
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