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Course

CT: Prospective Preparation for Internal and External Audits

FPM-40207

This course provides a step-by-step outline of internal and external audits as well as ongoing actions that should be taken to prepare for an audit. Topics include types of audits; the audit process (sites, sponsors, CROs); planning/preparing for an audit; rules of behavior during and after the audit; and dealing with the results.

Course Information

Online
1.00 unit
$325.00
Notes: Prerequisite: Good Clinical Practices (FPM 40204 or equivalent) or 2 years clinical research experience. Elective for Professional Certificate in Clinical Trials Design and Management.

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This course applies to these programs

Clinical Trials Design and Management

Course sessions

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Section ID:

185925

Class type:

Online Asynchronous.

This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

Textbooks:

No textbook required.

Policies:

Schedule:

No information available at this time.
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Instructor: James Morton

James Morton
Dr. James Morton received his doctorate of pharmacy degree form the University of Southern California. He is a Senior clinical research professional with over a decade of experience in clinical operations as a consultant, with AbbVie and Therapeutics Incorporated and over a decade of experience in clinical development with Quest Diagnostics. He has developed specific expertise in planning, implementation, oversight, monitoring, project management and completion of clinical studies. His work as lead to successful FDA approvals for three BOTOX indications; glabella lines, hyperhidrosis and migraine headache. Additionally he has supported successful clinical validations of over 50 LDT, including EUA for Quest COVID-19 At-Home Rapid Antigen Test.
 
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