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Good Manufacturing Practices GMP

Featured Instructor

Sean Develin

Sean Develin
Specialties: Regulatory

Sean Develin – with nearly 20 years in regulated industry – is co-founder of DevRose Systems. This UK and US-based consultancy provides information technology, validated cloud, auditing and compliance services to regulated clients worldwide. He is also an adjunct faculty member of the Temple University School of Pharmacy; where he teaches Bioethics, Auditing and Validation.

Prior to launching DevRose Systems, Mr. Develin built and managed the validation practice for Falcon Consulting Group and was Director of Validation for Omnicare Clinical Research. His expertise ranges from human research protections to vendor management and data integrity. His work has been extensively audited by regulatory agencies, study sponsors and hosting clients.

 

COURSES:

About Us

CfPIE provides pharmaceutical training, medical device courses and certification programs for a wide variety of industry professionals.  Consistently recognized by regulatory authorities as the leading provider of high quality training across the globe, CfPIE utilizes highly qualified instructors who are outstanding leaders in their fields.  Courses cover a variety of topics including pharmaceutical GxP, medical device design control and validation, process validation for drugs, devices and combination products, as well as numerous courses covering a wide-range of regulatory affairs training and quality system instruction.

CfPIE training programs focus on the latest regulatory guidances issued by the FDA and EMA, as well as updates to FDA compliance and inspections involving GMP, GCP and GLP processes.  Much of our life science and pharmaceutical training course program centers on how to avoid warning letters by ensuring that your operational guidelines meet the latest regulatory compliance. These courses range from medical writing programs, clinical trial design and management, QA/QC training, as well as CMC, biologics, biotechnology and clinical research.

CfPIE also offers the widest range of pharmaceutical and medical device certification programs designed to enhance career advancement.  Presently, over 3500 individuals are enrolled in Certification Programs covering GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management, QSR and CMC.  Over 1200 have already completed Certification and advanced their careers. 

In addition to the 300+ public courses offered annually, CfPIE is also the leading provider of on-site customized training to both industry and regulatory agencies around the world.  Customers have included the FDA, NIH, EMA, US Defense Department, Saudi FDA, as well as numerous European based national regulatory bodies. 
 

Pharmaceutical Training Courses

Our life science and pharmaceutical training course instructors frequently deliver FDA regulatory training topics designed to enhance inspection readiness, study design, clinical trial management, CMC guidance, computer system validation and the latest developments in medical device compliance.