Inspection readiness MasterClass - EU edition
09-10 September, 2025
Global regulatory bodies' inspection frameworks
This comprehensive training course provides participants with the essential information needed to plan to prepare for clinical trial or program regulatory inspections across multiple regions.
09-10 September, 2025, Virtual
Time Zone: UTC/GMT+1 /CET
Overview
This comprehensive training course provides participants with the essential information needed to plan to prepare for clinical trial or program regulatory inspections across multiple regions. The course explains the key differences between Inspection Preparedness and Inspection Readiness, as well as the triggers that prompt regulatory inspections. We are in a new era of inspection readiness. Participants will learn about the essential important workstreams for inspection preparedness and readiness, and how to make them their own for their company.
The course includes resources for keeping up to date related to global regulatory bodies inspection frameworks including those of the FDAs Bioresearch Monitoring (BIMO) program, the EMA, MHRA, and Health Canada. The training covers best practices for achieving and maturing inspection preparedness programs. Learners will navigate the inspection process with case scenarios. Sharing of recent experiences of new types of inspections, potential outcomes, and effective strategies for responding to observations, including corrective and preventative actions (CAPA). This includes what are common deficiencies and important things to consider. This course equips professionals with the tools to assess current programs and update approaches for the new era of inspections for clinical product development.
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WHO SHOULD ATTEND
-Sponsor personnel
-CRO personnel
-Investigators
-Site staff
-Quality assurance professional
-Others involved in inspection readiness activities
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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Years of experience
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