Surviving an FDA Sponsor Inspection - Training for Success

Steve Schwartz, is the founder of Solaris Research Corporation. He has a biology degree with a major in microbiology. He has 7 years of virology research in pharma, and moved into clinical research program administration for 6 years in the pharmaceutical industry. Entering the CRO industry, he performed clinical monitoring and clinical quality assurance field service using that expertise to achieve a management position at the director level over the next 10 years. 10 years of CRO experience culminated in the formation of his full service CRO in 1989 to 2008 , under the initial name of Commonwealth Clinical Research Corporation- later Solaris Research Corp. Steve has also served as the investigator for several phase four clinical trials. He has served on an academic IRB. After a brief retirement he worked as Senior Manager, Global Clinical Operations/ GCP in pharma. for 4 years until 2012. Escaping from the corporate environment he is again in retirement and continues to speak and consult to enable the sharing of his experience and expertise in CQA, regulatory affairs, and clinical operations including SOP, TMF, clinical monitoring, and best practices. Steve has designed basic and advanced CQA courses for delivery to Health Canada and US Government agencies, to the pharmaceutical industry, and to academic institutions. He has provided clinical program management, clinical monitoring, CQA auditing and regulatory consulting. Steve published a monthly electronic clinical trial conduct newsletter from 2000 to 2008.