Engaged. Knowledge. Application
FDA Enforcement Trends-GCP: A Primer for Preparing for 2010
What are FDA’s regulatory expectations in 2010 related to Good Clinical Practice? Are you prepared?
28 GCP-related Warning letters were issued by FDA in the first three quarters of 2009. enKap’s information package is presented in an non compliance audit observation (problem) and suggested CAPA (solution) format, including the following “hot topics:”
➢Informed Consent Process
➢Investigator Sites
➢Sponsors
➢Investigator Oversight
➢Sponsor Trial Management
➢Protocol Violations
➢Management of Investigational Products
➢Source Documents
➢Electronic Source
➢Essential Documents
What steps are being taken to strengthen the enforcement system at FDA-procedural changes Two new FDA regulations affecting FDA-regulated clinical trials Health Canada Initiatives EMEA-FDA GCP Joint Initiatives
Presented by Chris Brouillard-Pierce
Chris Brouillard-Pierce is an Independent Clinical Quality Assurance (CQA) consultant with over 20 years of experience in clinical research. Since 1996, her primary focus has been in the areas of GCP training and quality assurance-providing CQA expertise and conducting GCP industry audits (i.e., pharmaceutical, biotech, CROs and investigator sites), performing GCP audits of investigational product and investigational device clinical trials (Phase I– IV) throughout North America and the UK. In addition, she has hands-on experience in assisting sponsors and investigator sites in preparing and responding to regulatory inspections.
Your Information Package includes:
➢Powerpoint Training Presentation (PDF)
➢Webinar Recording
➢Free Membership in enKap's FDA Compliance learning community - simply fill out a profile
Purchase Your Information Package in our enKap Store
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