Clinical Monitoring: Essential Concepts provides an overview of clinical monitoring in the context of the overall drug development process, FDA regulations and International Conference on Harmonization (ICH) guidelines for Good Clinical Practices.

Good Laboratory Practices addresses regulatory compliance principles relative to the FDA’s current GLP regulations. Topics include: GLP development, roles and responsibilities of key staff members, Standard Operating Procedures (SOPs), laboratory facilities, and computer validation issues.

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“This information will help me provide more adequate reporting compliance.”

“I can better identify situations that do not comply with GCP and address these situations.”