CfPIE Awarded Five Year Contract by FDA to provide Quality System Regulation Training to FDA Professionals

FDA sessions to begin March 2024, presented by Wen Schroeder,

long-time CfPIE course director.

Chester Springs, Pennsylvania, Dec 13, 2023

The Center for Professional Innovation and Education (CfPIE), the global leader in life sciences training, today announced that it has been selected by the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation & Research (CBER) to provide US Medical Device Regulation & Quality Management System Requirements to select FDA professionals, beginning March 2024 with options to continue through September 2028.

“The Agency understands and appreciates the need for Quality Management System (QMS) requirements that can apply to both large and small manufacturers for streamlining and harmonizing the standards for quality systems. As the Agency continues to apply least burdensome concepts for regulations, we recognize there is a need for a globally unified quality system that will reduce burdens to both industry and FDA,” expressed FDA in the Statement of Work. “FDA intends to harmonize QMS requirements for medical devices with the International Standards Organization’s (ISO) requirements for medical devices under the ISO 13485 (QMS Standard).” 

“CfPIE, which has been training FDA personnel since 2007, is excited to be part of this new harmonization effort. Our expertise, flexibility, and reputation make us the clear choice to provide direct training support to the FDA, the world’s leader in regulatory promotion and protection of public health,” states Mark Mazzie, CEO of CfPIE.

This fully customized course will be presented by Wen Schroeder, Quality Systems Regulation expert and CfPIE course director for the past 10 years. In addition, Ms. Schroeder will be presenting the following public courses for CfPIE several times throughout 2024, all via live stream:

• US Medical Device & Quality System Regulations - Design Controls & Validation
• OTC Drug and Personal Care Product GMP & FDA Regulation
• Overview of the New EU Medical Devices Regulations: MDR, IVDR, CE Mark and Compliance, QMS Fundamentals
• Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management

Visit this page for dates and times of their publicly offered live stream courses, or for information on bringing a fully customized course directly to your facility, either via live stream or in person presentations, visit https://www.cfpie.com/custom-on-site-training.

About CfPIE

The Center for Professional Innovation and Education (CfPIE) is the global leader in life sciences training, providing specialized courses for pharma, biotech and medical device topics. Classroom and custom on-site formats, and certification programs help improve personal skills, maintain regulatory compliance, and advance careers. Small class sizes and industry-active course directors promote a dynamic learning environment with excellent student-to-teacher interaction. More information: https://www.cfpie.com

About Wen Schroeder

Wen Schroeder is the founder and president of SEKI Cosmeticals. With 20+ years of industrial experience, 30 US patents and author of numerous publications, Ms. Schroeder is an internationally recognized lecturer in medical device regulations & regulatory affairs covering a wide range of subject areas, including design product performance & safety testing programs for pharmaceutical, medical devices, and food products. She is a key expert for numerous cross-governmental aid programs including the ASEAN-EU Programme, under the European Commission, for Regional Integration Support in GMP and testing. She has taught numerous training workshops for the European Commission EU-Aid Program covering topics such as, Drugs/Medical Device, Generic Drugs, ACTD, Labelling, Pharma GMP, PICS, ACTR, Stability, BA/BE, Validation, Contract Manufacturing/CRO, Microbiological Controls, and Good Clinical Practices. More information:click here.

About FDA CBER

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products. More information:click here.