Malvern, PA (PRWEB) December 18, 2013
The Center for Professional Innovation and Education (CfPIE)—a global provider of life sciences technical training—is now a Regulatory Affairs Professionals Society (RAPS) RA Professional Development Portal provider. CfPIE specializes in FDA regulatory compliance training and now awards Regulatory Affairs Recertification (RAC) points through a large selection of pharmaceutical, biotechnology, and medical device courses.
“We are committed to providing quality education to allow regulatory professionals worldwide to stay in-the-know and enhance skills, while supporting career advancement opportunities,” says Mark Mazzie, CfPIE founder and Managing Director. “More than half of our classroom courses count for up to 12 RAC points to help individuals quickly earn their professional development credits.”
CfPIE’s Course Directors are highly-experienced, industry-active and hold senior-level scientific, regulatory and management positions in the life sciences industry. They offer a comprehensive knowledge base that goes into every course they provide. Class sizes are limited to 20 attendees, ensuring an engaging learning environment.
A selection of regulatory-specific courses within CfPIE’s comprehensive curriculum includes:
Adverse Drug Events: Reporting & Regulatory Requirements. This course will provide participants 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.
The Center for Professional Innovation and Education (CfPIE) is the global leader in pharmaceutical, biotechnology, medical device, and skin/cosmetics technical training within the life sciences industry. CfPIE offers more than 350 class sessions annually across 71 course titles. Multiple learning formats—classroom, customized on-site presentation and certification programs—provides individuals and companies with versatile choices for improving personal skills, maintaining regulatory compliance, and creating opportunities for career advancement.