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FDA Inspections of Clinical Data Systems




Who Should Attend

This course is designed for Quality, Data Management and IT personnel responsible for Clinical Data Systems implementation, operation and compliance. The course is of special value to personnel seeking experience with the quality issues associated with regulated computer systems.



Learning Objectives

The course will provide the tools needed to prepare for a Clinical Data System inspection and to assess risk areas that need prioritization. Attendees will learn how to review the system for regulatory vulnerabilities and to develop an action plan intended to close those gaps.



Course Description

This course focuses on preparation for FDA systems inspections whether establishing a new program or seeking improvements in an ongoing quality initiative. The course provides practical information for improving presentation and substance of Clinical Data Systems documentation in anticipation of a FDA Inspection. In addition, the course will address critical issues and potential observations resulting from a Clinical Data Systems audit.

The attendee will be able to develop action plans based on course material to improve the company's compliance position for an inspection. The executed plans will also strengthen evidence that the Clinical Data System performs to business and quality expectations.

Topics include the following: Inspection Fundamentals; Computer Validation and Part 11 Inspection Concerns; Assessing Standard Operating Procedures; Assessing System Documentation; Preparing for the Inspection and Maintaining Compliance.



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Past Participants Comments:
 

“The course material was highly organized and the lecturer has demonstrated clear knowledge of the course.  I have learned so much from this course and it will be very useful to me in my workplace.  I will really recommend CfPIE courses to my colleagues.  Thank you so much!” 
Busisiwe M., Senior Data Manager, CHBH South Africa

“The thorough review of applying 21 CFR Part II and linking it to other practices (GXP) was very useful.  The trainers ability to field specific situational questions and provide detailed feedback is very refreshing compared to other courses I have taken.”  
Anthony S., Process Engineer, Boston Scientific

"The instructor is very knowledgeable about the IT perspective of Clinical Data Systems."
Department Head, Singapore Health Services Pte Ltd.
 
"Material was well presented and Instructor was very knowledgeable."
Associate Director - Bayer
 
"I would recommend this course to others."
Mike Y., Eisai

“This was an excellent course.  The examples were true to life.” 
Sara V., Director, Clinical Research, St. Jude Medical. Inc.

“This was an extremely valuable course with immediately useable ideas.  I have a long action item list to take home with me.” 
Shannon L., Mgr. Clinical Data Mgmt., Tyco Healthcare

“The presenter was very knowledgeable, and was able to answer all questions put forward.” 
Jayendren M., Sr. IT Administrator

"Great Content! I can put it to use immediately.  Excellent opportunity to verify status of readiness and quality systems infrastructure."
James W.,  Quality Manager, Fred Hutchinson Cancer Research Center

“The class had good flow; I also thought there was good group interaction.  The Course Director used personal experience we could relate to and made info more retainable.” 
Rebecca S., Manager Computer Validation, Neurocrine Biosciences


 Please Select a Location / Date Before clicking on the Register Button:

Certification Programs available for this Course:
Clinical Compliance Certified Professional (CCCP)

Related Courses:
The EU Clinical Trial Directive
FDA Inspections: What To Expect And How To Prepare
Good Clinical Practices (GCPs)
Validation of Computer Systems
Writing Effective Standard Operating Procedures and Other Process Documents



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