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Preparing for SOP Inspection: An Auditor's Perspective March 2012

Course Description

One is hard-pressed to find anyone in the drugs/biologics/medical device industry who is not aware of SOPs (Standard Operating Procedures). Unfortunately, quality and usability vary widely. Many SOPs fall short of fulfilling their role as compliance and training tools. Many in the industry view SOPs as a necessary evil; but it does not have to be so.

The goal of this web seminar series is to help attendees create user-friendly SOPs that continuously support standards for quality and validity of data, as required by the regulations, while also providing value to their users.

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Learning Objectives

  • Examine the true purpose of SOPs and systems for compliant development, implementation, and management
  • Discuss the FDA’s new expectations for SOPs from Sponsors/CROS and Clinical Investigators (with an update on IRB requirements)
  • Review recent case studies concerning issues in SOP documentation and implementation practices

Who Should Attend

  • SOP Authors/Reviewers
  • Quality Assurance Auditors
  • Clinical Monitors
  • Site Managers
  • Line Function Heads
  • Project Managers

Instructor

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

 

 

 

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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
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GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


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Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)