PPT-Sponsor-Investigator (SI) FDA Inspections

Christiana Provencal MA Quality Assurance Quality Improvement Administrator April 13 2018 Inspection assignments are issued by the FDA Center to the District Office There are two types of inspections. Southwest . Housing Compliance . Corporation. Presented . by: . Brad Kothmann. Director of Property Standards & . REAC Inspector. July 23, . 2015. Preparing for REAC Inspections: The Quick and Easy. MIAP – Introduction to INDs and IDEs. E Mitchell Seymour, PhD RAC. Research Faculty. Regulatory Project Manager. educate • fund • connect • support. MICHR is here to . enable . & . enhance . Investigator-Initiated . v. Sponsor-Initiated Clinical Trials – What are the special contract and administration issues to be aware of?  . NCURA Western Regional Conference April 5, 2011 – Denver, CO. Bruce Ross. , . M.A. M.P.H.. Director, India Office. Agenda. Priorities. Challenges of globalization. cGMP. . deficiencies. Comparison. Post inspection regulatory . actions. 2. Advance Regulatory Science: the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated products. Jan Zolkower, MSHL, CIP, CCRP. January 13, 2012. Review Investigator Responsibilities. Discuss recent FDA Warning letters and OHRP Determination letters. Review of Advanced Notice of Proposed Rulemaking (ANPRM). Shannon Simmons, BA, CIP. March 14, 2014. Process Improvement Team. Vanderbilt Human Research Protections Program. Agenda. Review Investigator Responsibilities. Discuss FDA Warning letters . Q & A. Investigator-Initiated . v. Sponsor-Initiated Clinical Trials – What are the special contract and administration issues to be aware of?  . NCURA Western Regional Conference April 5, 2011 – Denver, CO. Top 10 Vehicle Defects. 2. No.. Description. Severity. 1.. Inoperative Required Lamp. 2. 2.. No. or defective lighting or reflective devices. 3. 3.. Brake hose/tubing chaffing and/or. kinking. 4. 4.. Denise Webster. Fresh & Easy. April 3, 2014. Purpose is . not. to give you legal advice but to give you first hand experience and best practices in preparing for an FDA or Health Department audit. . Kathy Gilmartin, MSN, CRNP, CCRC. Manager of Clinical Trials Quality Assurance. Background. FDA inspections are typically conducted at clinical sites to determine compliance with federal regulations and adherence to guidelines, to verify the . Overview of Good Clinical Practices (GCP) . Investigator and Study Team Responsibilities. Miles McFann. IRB Administration. Training and Outreach. 2. Good Clinical Practice is the compilation of accepted ethical and scientific standards governing clinical research that ensure the integrity of data obtained and the protection of human research subjects.. When Negotiating a Clinical Studies Agreement Living Document As of May 21 , 2010 Version 2 .0 Living Document Page 1 of 13 As of May 21, 2010 Introduction Collaboration of academic institutions w Daniel R LevinsonInspector General The mission of the Office of Inspector General OIG as mandated by Public Law 95-452 as amended is to protect the integrity of the Department of HealHHS programs as w Presented by the . Research Quality Compliance Network.  . PRESENTERS. Ginger Bair, CCRP – QA/QC Coordinator, Office of Quality Compliance and CTSI. Josh Fessel, MD, PhD . –. . Senior Clinical Advisor, Division of Clinical Innovation, NCATS and NIH.