Good Clinical Practice for the Laboratory Scientist

Upcoming Courses

Course #: SGLA0514
May 13, 2014
The Hub Meeting Center - Commerce Square
Philadelphia, PA

Course Description 

This course is designed particularly for the laboratory scientist to provide an appreciation of the regulated environment in which clinical studies are conducted and its relevance when collecting and analyzing biological specimens during a study. The drug development process (discovery through post-market) will be reviewed with particular attention to the fundamentals of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and where/how they apply. Examples and the impact of non-compliance will be discussed. Review and reinforcement of important concepts, such as laboratory accreditation, will be achieved through discussion and examples. The role of quality management in GCP Laboratories will be evaluated along with the standards to have in place that will ensure compliance, including outsourcing clinical laboratory activities. The challenges when conducting global studies related to specimen collection will also be discussed. 

Learning Objectives 

  • Review the drug development process from discovery through post-market 
  • Describe the regulated environment in which clinical studies are conducted, including the handling/analyzing of biological specimens 
  • Discuss the fundamentals of GLP, GCP and GMP and where/how they apply 
  • Provide examples and impact of non-compliance with GLP/GCP 
  • Describe the role of quality management in GCP laboratories and the standards to have in place that will ensure compliance 
  • Discuss outsourcing clinical laboratory activities to minimize compliance risks 
  • Identify the role of laboratory accreditation in clinical studies 
  • Discuss the additional challenges related to specimen collection when conducting global studies 
Who Should Attend

  • Laboratory scientists 
  • Research assistants 
  • Laboratory supervisors 
  • Principal scientists 
  • Research personnel that write protocols and/or handle/analyze biological specimens collected during a clinical study (analysis for drug metabolites, biomarkers, investigational products) 

Gary B. Freeman, M.S., C.C.R.A. 

Click here for complete trainer biographies 

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • Overview of the drug development process: Discovery through post-market 
  • Working in a regulated environment: Definitions of GLP, GCP, and GMP; Global regulatory authorities – mission and responsibilities; Regulations – US (Code of Federal Regulation); ex-US (International Conference on Harmonization – ICH; EU Directive); forgotten elements 
  • Fundamentals of GLP, GCP and GMP: Non-clinical testing (GLP) – elements and examples of non-compliance; Clinical research (GCP) – elements, sponsor responsibilities, examples of non-compliance; Investigational product manufacture (GMP) – elements and examples of non-compliance 
  • Quality Management of GCP Laboratories: Laboratory Quality System identification, Qualifications, Outsourcing, Accreditation, Challenges with global studies 

Interactive Activities 

  • Situational reviews of practical scenarios 
  • Critique of current FDA Warning Letters 
  • Group discussions 


Registration Fees 

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day. 

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings. 

Click here for our seminar cancellation policy 

Accreditation Information 

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-11-054-L01-P. Released 9/11. 

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471. 


LinkedIn twitter Facebook 

On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.

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. 

BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

Jan - July 2014 Edition

Winter CatalogDownload Today!  

Blended Curriculum Path for the CRA, CRC, and Project Manager

BCP Cover

Download Today! 






 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


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  


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)