Surviving an FDA Sponsor Inspection - Training for Success

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This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

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
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Stephen Schwartz,

Stephen Schwartz, CIC is the founder of Commonwealth Clinical Research Services (later as Solaris Research Corporation), a full service CRO from 1989 to 2009. Steve worked in clinical project development for Pharma for 16 years and for 20 years as a CRO with experience in devices, biologicals, diagnostics, and therapeutics in most of the clinical indications for all study phases, as well as pre-clinical activities. Steve has extensive field experience as a CRA and as a CQA auditor, He has demonstrated expertise in Clinical Operations, including the functions of clinical monitoring, program management, product development, CQA, and inspectional operations. He has recently retired from Pharma where he was Sr.Manager, Global Clinical Operations. His current projects as a consultant include CQA inspections and training, Gap Analysis Audits, and Clinical Project Oversight for an international Pharma program.

Get in touch

(315) 632-0735,
(315) 750-4379