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CfPIE Provides Regulatory Affairs Recertification (RAC) Points Recognized by the Regulatory Affairs Professionals Society (RAPS)
Date:12/18/2013

icipants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as international law/regulations, ICH guidelines, pharmacovigilance, definitions and current regulatory issues.

Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products. This course is designed to provide participants with an understanding of the parameters for regulatory compliance, successful approaches to compliance, and meeting the concerns of regulators.

FDA Inspections: What Regulators Expect and How to Prepare. This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities.

Pharmaceutical and Biopharmaceutical Quality Control Laboratories: A Regulatory Compliance Primer. This course is intended to give participants a thorough overview and practical understanding of Current Good Manufacturing Practices for laboratory compliance.

About CfPIE

The Center for Professional Innovation and Education (CfPIE) is the global leader in pharmaceutical, biotechnology, medical device, and skin/cosmetics technical tra
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