Surviving an FDA Sponsor Inspection - Training for Success
Instructor:
Stephen Schwartz
Product ID: 704516
Training Level: Advanced
- Duration: 105 Min
Why Should You Attend:
The sponsor clinical operations staff guided the sponsor and investigator site staff through the FDA inspection/audit process. The result was a passed FDA sponsor inspection and approved NDA. There were no FDA warning letters issued to any investigators.
This webinar will discuss how seemingly insurmountable obstacles to a successful FDA sponsor inspection were resolved and how you can apply these lessons to your next FDA sponsor inspection.
Areas Covered in the Webinar:
- FDA inspectional procedures; What sponsor staff are audit targets and how FDA inspections are performed
- Sponsor SOP and TMF options that work and do not work toward complying with FDA documentation requirement
- FDA sponsor inspection objectives and perspectives
- Typical and common FDA questions and how not to respond
- The impact of CRO contractual delegation of project responsibilities on sponsor regulatory obligations
- Audit of sponsor records and training of sponsor staff as a positive step in preparing for the inspection
Who Will Benefit:
- CQA
- Regulatory personnel
- Clinical operations, CRA
- Director and upper level pharma research management
- Investigators and research management staff
- Clinical Project Manager
- Regulatory Affairs
- Compliance Manager
- Trial Master File Manager
Recently Asked Questions:
- For FDA inspection of sites outside of the US, what are some considerations?
- Can you provide some insights about the timing of the FDA inspections after submitting the NDA?
Stephen Schwartz
Founder, Solaris Research Corporation
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.
More Training By Experts
- Why investigators often lose money in conducting sponsored clinical trials
- When does GCP Non-compliance at an investigator site compromise a regulatory submission? To File Or Not To File - that is the question!
- The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?
- How Sponsors Generate GCP Noncompliance at Investigator Sites
- FDA Regulatory Inspection and Audit Training: Pack of 6 Training Courses
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