Cambridge Healthtech Institute and Barnett Educational Services Introduce Good Clinical Practices

May 18, 2011 - PRLog -- NEEDHAM, MASS. –  Cambridge Healthtech Institute and Barnett Educational Services introduces 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."

Good Clinical Practice has been defined by the International Conference on Harmonization as "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected."

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 used directly in the GCP environment, including a full set of GCP inspection sheets.

The Guide is available in hardcopy or 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 more information and to purchase, visit: http://www.barnettinternational.com/


About Barnett International (http://www.barnettinternational.com/)

Founded in 1979, Barnett International is widely recognized for its superior targeted education and training programs and consulting services. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The Barnett approach is a unique combination of strategy development and practical, hands-on implementation. The "Barnett Difference" is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver.

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Since 1992, Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations.