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How to Always be Inspection-Ready Digital Recording (March 27, 2013)

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ISCT Webinar: How to Always be Inspection Ready
Presented by the ISCT North America Legal and Regulatory Affairs Committee
Date: March 27th, 2013
Time: 9:00 AM Pacific, 11:00 AM Central, 12:00PM Eastern, 6:00 PM CET (Europe)
 Chair: Olive Sturtevant, MSc, Director, Cell Therapy Quality Assurance, Dana Farber Cancer Institute, Massachusetts, USA

Speakers: Olive Sturtevant and Ed Brindle, MSc, MT, Manager, Quality and Regulatory Affairs at Insception Biosciences, Ontario, Canada

About the Webinar:

Are you inspection ready for accrediting or regulatory agencies that might knock on your door? In this ever changing and heavy regulated field of cellular therapy, it is a challenge to keep current with the variety of agencies that inspect and accredit our manufacturing and testing labs. With more and more international clinical trials, many of our labs are subject to inspections from international agencies. Once you understand the focus of each agency assessing, you can better prepared for those encounters. Aside from looking at the basics, this webinar will take a more in-depth look at similarities and differences between US, Canadian and UK agencies. There are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections

Learning Objectives

  • This session will cover the how to prepare for any assessment from an accrediting or regulatory agency
  • Review commonalities and differences in between US, Canadian and UK Inspections and assessments for product manufacturing
  • We will address how to handle sensitive areas and documents depending on the agency involved
  • Address the common deficiencies and findings and how you might avoid them
  • How to make this a good learning experience useful process for improving quality and ensuring compliance.

Who should attend?

Quality & Regulatory Staff responsible for compliance

Laboratory staff

Managers and Supervisors

Why you should attend

Cell Therapy programs and manufacturers are subject to numerous inspections from a variety of agencies with different areas of focus. This webinar will address common practices to prepare for both the announced and unannounced audits. We will also discuss some of the similarities and difference between US and International inspections and assessments that are common areas focused on for cell therapy manufacturers.

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