The Quality Assurance/Compliance certificate program familiarizes professionals with the key regulatory and quality requirements pertaining to their specialty area (clinical, laboratory, or manufacturing) and prepares them to ensure that the products and processes they oversee comply with these requirements.
This educational track is designed for clinical professionals working as:
To earn the certificate, you must complete THREE core courses and ONE elective course from the list below. Courses must be completed within five years to remain eligible for earning a PERI certificate. Once you have completed the required courses, contact the PERI Registrar for validation, and the Quality Assurance/Compliance certificate will be mailed to you. If you have questions about your progress, contact PERI at info@peri.org .
Core Courses
- Global Pharmacovigilance Training CourseOpen or Close
This course focuses on global regulatory requirements required for the management of product safety data from clinical trial and postmarket sources.
- Introduction to Global Regulatory Affairs: Overview of Pharmaceuticals & BiologicsOpen or Close
This course provides a comprehensive overview of US, European, Canadian, Japanese and Rest-of-World (ROW)/ Emerging Market regulations for drug and biologic development from pre-clinical to post approval.
- Applied Good Clinical PracticesOpen or Close
This online course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. Learn More
- Clinical Monitoring and Site ManagementOpen or Close
The goal of this online course is to provide a practical orientation to site management and monitoring of clinical studies.
- GCP for the Clinical Research Team seriesOpen or Close
These virtual courses provide a review of the clinical trial process. This series is different from many other courses in that its perspective is from that of the site based investigator rather than the sponsor. Learn More
Upcoming Elective Courses
- Basic Drug Development: Overview of Biopharmaceutical Research & DevelopmentOpen or Close
In a blending of online and live learning, this course provides an overview of the process and issues common to all new chemical entity (NCE) development projects, from the research and development stages through product launch and post-marketing safety.
Next Offering:May 18-19, 2017 – Fairfax, Virginia, USA
- Cancer: Pathophysiology, Current Therapies, Clinical Trials, and Drug DevelopmentOpen or Close
This course provides an overview of human cancer with discussions of specific cancer types, current therapeutics and design of clinical trials.
- Implementing Effective Global Clinical Trial Management and OperationsOpen or Close
This course addresses clinical trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry.
- Project Management in the Research-Based Pharmaceutical IndustryOpen or Close
This course addresses project management issues and skills needed to wisely choose and effectively develop new therapies in today’s global climate.
Next Offering:March 30-31, 2017 – Fairfax, Virginia, USA
- Regulation of Marketing and Promotion of Prescription DrugsOpen or Close
This course presents industry and FDA experts on current issues regarding FDA regulation of promotional activities such as direct-to-consumer advertising, social media, scientific exhibits, off-label communications as well as trends in FDA enforcement.
Next Offering:April 3-4, 2017 – Fairfax, Virginia, USA
- Decision Points in Pharmaceutical DevelopmentOpen or Close
This introductory web-based module focuses on the critical decisions that are made throughout the development of a new chemical entity as the process evolves from discovery to first in humans and ultimately to launch.
Revised and refreshed – updated November 2015!
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