Changes That COVID-19 Forced in the Way Inspections and Reviews Are Handled by Regulatory Agencies
The global pharmaceutical industry continues to face unexpected challenges in responding to the world’s pandemic. The impact on normal operations has been felt in companies of all sizes, with varying manufacturing capabilities, no more intensely than in the Asia Pacific region.
The 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will address this impact and the most critical issues, with a special emphasis on practical application using a series of case studies implementing quality risk management (QRM) principals.
Register now to benefit from unparalleled real-time engagement with regulatory leaders and industry during interactive sessions and panel discussions as they share their perspectives on how to:
Implement QRM principles in addressing OOS investigations, cross contamination, data review, and aseptic processing controls
Navigate distance assessments, audits, and alternative avenues for reviews
Develop comprehensive responses to regulatory actions - And more
In this clip, hear from David Churchward, Program Committee Member, Deputy Unit Manager, Inspectorate Strategy & Innovation, Medicines and Healthcare products Regulatory Agency (MHRA), as he answers the question: What are the two most significant changes that COVID-19 forced in the way inspections and reviews are handled by regulatory agencies?
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