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Good Clinical Practices: Guide to Compliance

- $499.00

Introducing a new series of guides to the US and international regulations governing the research, development, and manufacture of biotechnology and pharmaceutical products, commonly referred to as the "GxP Regulations." This series is intended to aid companies seeking information and practical advice on efficiently establishing full compliance with Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice.

These guides summarize the latest regulations and guidances issued by the FDA and the regulatory authorities in Canada, the European Union, and Japan; provide detailed analysis of these regulations; and provide practical advice and examples of how best to implement them. The aim of the guides is to provide simple and concise interpretation of these regulations and to provide effective solutions for their implementation in the development manufacturing, pilot plant, manufacturing facility, and clinical trial sites.

Good Clinical Practices: Guide to Compliance, provides clear recommendations for full compliance with global regulatory requirements. The Guide includes templates for SOPs and other forms that can be copied and used directly in the GCP environment, including a full set of GCP inspection sheets.

This report will be available in electronic format and includes chapters and appendices covering the following information:

  • Comparison of International GCP Regulations
  • Regulatory Submission for GCP Data
  • Critical Compliance Issues
  • Internal and External Inspections and Audits
  • SOP Templates

For bulk orders and custom cover pricing and options, please contact Elizabeth Andrews at 781-972-5418 or eandrews@healthtech.com.




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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.

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

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

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Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


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)