PHARMA/BIOTECH/MEDICAL DEVICES WITH XOOLI
FDA Overview of Regulatory Requirements for Medical Devices from XOOLI
Now on Mobile Devices
The FDA`s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Medical devices are classified within Classes I-III and regulatory control increases with each class. The device classification regulation defines the regulatory requirements for a general device type, as well as all premarket requirements and expectations. This course is intended to provide a vital overview of the regulatory requirements for medical devices or, as it is sometimes called, Devices 101.
WHAT YOU WILL LEARN
This course will provide you with a comprehensive overview of what products are regulated as medical devices, how to determine the classification of your devices, how to ensure that your establishment is registered correctly, and other information on medical device manufacturing regulations.
BASIC & INTERMEDIATE
- Comprehensive overview of the Center for Medical Devices & Radiological Health (CDRH)
- The complete Medical Device Classification system and details
- An overview of medical devices and their individual regulations
- A primer on medical device controls
- All Establishment Registration information, including premarket notification specifics, exemptions, and Pre-Market Approval (PMA)
- CEOs and VPs
- Hospital Administrators
- Doctors and Nurses
- Regulatory, Quality VPs and IT VPs
- Regulatory Affairs professionals
- Quality Managers and Engineers
- Small business owners
- GxP Personnel
“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Expertly formulated device manufacturing and labelling provides regulatory assurance, improves overall product quality, reduces recalls and shortages, and improves manufacturing consistency.
Utilizing a risk-based approach, this course provides the background and full view of the FDA’s Center for Devices and Radiological Health (CDRH) as it applies to regulations and requirements for medical devices.
Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
Provides skill-building and leadership training for regulated industry professionals with RAPS credit — available now on Mobile Devices.
Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.
XOOLI is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform
Course Author Bio
Ms. Angela Bazigos
Chief Compliance Officer and Head of Life Sciences
Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Angela has more than 40 years of experience working with life sciences and healthcare organizations around the world. She is a Past President of PRCSQA, a member of the SQA, CVIC, ASQ, DIA and RAPS. She co-authored Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA and is a frequent contributor to international and industry publications. Ms. Bazigos was recently quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Ms. Bazigos additionally served as CCO for Prime Genomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.