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 professionals working as:
- Clinical Quality Assurance Auditor
- Compliance Specialists
- Quality Assurance
- Regulatory Compliance
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
This intermediate course explores the three key phases of clinical development of pharmaceuticals and addresses the skills needed to effectively and safely conduct global clinical trials.
This course focuses on global regulatory requirements required for the management of product safety data from clinical trial and postmarket sources.
This online course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide.
The goal of this online course is to provide a practical orientation to site management and monitoring of clinical studies.
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.
Elective Courses
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.
*NOTE: Students may only count Basic Drug Development or Decision Points in Pharmaceutical Development as one of the elective courses.
This course provides an overview of human cancer with discussions on specific cancer types, current therapeutics and clinical trial design.
This course addresses clinical trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry.
This course addresses project management issues and skills needed to wisely choose and effectively develop new therapies in today’s global climate.
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.
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.
*NOTE: Students may only count Basic Drug Development or Decision Points in Pharmaceutical Development as one of the elective core courses.
Continuing Education Credits
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit.
Continuing Medical Education (CME)
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Pharmacy Education (CPE)
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This is an application-based CPE Activity.
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