We will review the latest inspection statistics released from FDA, discuss how to prepare for an FDA Inspection, discuss how to repsond to an FDA Inspection and discuss the possible outcomes of an FDA Inspection that has resulted in significant findings and/or citations.
Why should you Attend :
In 2010 under CDRH, CDER and CBER divisions alone, FDA classified 1,097 Sponsor, Site and IRB Inspections. Of those Inspections 9% or ~ 66 of the Clinical Investigator Inspections, 6% or ~ 15 of the IRB Inspections and 12% or ~ 15 of the Sponsor/Monitor Inspections were categorized as "Official Action Indicated". 45% of Clinical Investigator, 50% of IRB and 38% of Sponsor/Monitor Inspections were categorized as "Voluntary Action Indicated" being required. Because FDA Inspections are part of doing business and getting products to market, Clinical Investigators, Sponsors and IRBs should not only be prepared to handle an FDA Inspection but also be prepared to follow-up on findings, following the inpsection.
Areas Covered in the Session:
- Preparing for an FDA Inspection.
- Discussion on receiving and responding to 483s and warning letters.
- Discussion on what actions the FDA can take over and beyond issuing a 483 or Warning Letter.
Who will benefit:
Clinical Research managers
Clinical Research Associates
Quality Assurance Professionals
Lee Truax-Bellows has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Regulatory Consultant Monitor, Medical Communications Associate, Senior Quality Auditor, Senior Trainer and Project Manager. Lee has been involved in regulated research for over 20 plus years and specializes in product development, GCP auditing, and training on regulated research and Good Clinical Practice.
Lee is a founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a clinical contract research organization (CRO) based in upstate NY. NCRA has been providing clinical research expertise in medical device, pharmaceutical, and nutraceutical development since 1994. NCRA provides full service CRO services such as monitoring, auditing, technical writing, data management, biometrics and product development consulting.
Lee is active in the Association of Clinical Research Professionals (ACRP) and Society of Quality Assurance (SQA).
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