Surviving an FDA Sponsor Inspection - Training for Success

Instructor: Stephen Schwartz
Product ID: 704516
  • Duration: 75 Min

recorded version

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Read Frequently Asked Questions

This training program will review a fictional case study derived from several 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 that originated at the sponsor site. The course will also discuss sponsor/CRO/investigator relationship issues from these three site audits.

Why Should You Attend:

The sponsor staff was trained and guided through the inspectional process. Issues and remediation wherever possible were documented. Anticipated FDA questions were scripted as to the appropriate responses and inappropriate responses were reviewed so that they could be avoided. Potential FDA concerns about sponsor clinical research operational procedures (SOP) and project specific events (TMF) were prepared for presentation to FDA. The use of an electronic TMF to support the inspection was also addressed.

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
  • Who at the sponsor will be audited more than the clinical staff?
  • Sponsor SOP and TMF options that work and do not work toward complying with FDA documentation requirement
  • Why FDA performs sponsor inspections
  • Typical and common FDA questions and how not to respond
  • The impact of CRO contractual delegation of project responsibilities on sponsor regulatory obligations
  • The independent audit of sponsor records and training of sponsor staff as a positive step in preparing for the inspection

Who Will Benefit:

This course will benefit the investigators and site staff who will be inspected, the sponsor CRA, and institution quality staff and clinical administrators:

  • Clinical investigators and sub investigators
  • Quality assurance staff at sponsors and research institutions
  • Clinical research associates

Instructor Profile:

Steve Schwartz is the founder of Solaris Research Corporation. He has a background in basic virology research, progressing into 10 years clinical research program administration 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. He 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 for Reckitt Benckiser Pharmaceuticals from March 2008 until July 2012. Since his retirement, Mr. Schwartz continues to speak and consult internationally to enable the sharing of his experience and expertise in CQA, regulatory affairs, and clinical operations including SOP, TMF, and clinical monitoring best practices.

Relevant to clinical quality assurance, Mr. Schwartz 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. He published monthly electronic clinical trial conduct newsletters from 2000 to 2008.

Mr. Schwartz has a BS degree in microbiology/infectious disease with graduate courses in immunology/virology and pharmacology, and business management. He has, over twenty years, made many presentations on clinical operations, clinical monitoring, study program management, and CQA to clients and at several DIA meetings.

Topic Background:

It is critical that pharma sponsors understand the FDA inspectional perspective and procedures, especially so where there are indications of procedural or compliance deficiencies at the sponsor site or investigator sites or in the submitted data filing to FDA. The ability of the sponsor staff to recognize these inspectional issues before the inspection allows for remediation and training for appropriate inspectional responses to FDA on these issues.

Failure to be prepared for the inspection, and any inappropriate responses to FDA during the inspection are more likely to cause a failed inspection with loss of the regulatory submission application and FDA regulatory actions - than the procedural and noncompliance issues alone.

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