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Introduction

With the growth of the Pharmaceutical and Biotechnology industry, audits get more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other part, the sponsors also multiplied the audits from their part in the idea to try to downsize the risk of noncompliance during the trial. This presentation will help with preparing the site and the study team with how to comply with the new 21 CFR part 11 regulations, how to identify risk of noncompliance, and how to insure compliance.

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Venue

online

online, 10777 Westheimer Suite 1100, houston, 77042, United States

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Organised by

compliance2go

Contact information

Mr David jones
10777 Westheimer Suite 1100, Houston, Texas, 77042, United States of America
1.877.782.4696
Contact us by email

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