PHARMA/BIOTECH/MEDICAL DEVICES WITH XOOLI
Medical Device Establishment Registration and Listing for FDA Regulated Companies
from Morf Media Inc. Now on Mobile Devices
Medical device manufacturers have strict rules on processes, safety, quality control and review procedures. All of these regulations are vitally important for company success and the protection of everyone involved. Additionally, it is important for manufacturers to be knowledgeable about the requirements and regulations mandated for product registration and listing.
This presentation will provide the basic information needed to fulfill the FDA requirements for Medical Device Establishment Registration and Listing based on requirements and changes enacted with the legislation of 2012.
WHAT YOU WILL LEARN
This webinar will show you the context, the impact and the best practices related to the FDA’s 2012 legislation on medical device registration and listing. It is designed to aid managers and quality control personnel in the formation of new expectations and streamlined processes, based on information directly from the FDA.
BASIC & INTERMEDIATE
- A primer on regulatory requirements
- The full list of who is required to follow medical device registration and listing requirements and what exemptions may exist
- Specifics on when to register and list
- An overview of registration and listing information
- Complete FURLS information, including;
- FURLS Accounts and Passwords
- Owner Operator Account
- Official Correspondent Account
- Creating Multiple Accounts
- A list of User Fees
- Step-by-step instructions on how to follow regulations
- An FDA tutorial
- Hospital Administrators
- Doctors and Nurses
- Regulatory, Quality and IT VPs
- Regulatory Affairs professionals
- Quality Managers
- Quality Engineers
- Small business owners
- GxP practitioners
“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 registration and listing procedures provide speed, improve overall product processes, reduce negative FDA reactions, and help build a positive reputation.
Utilizing a risk-based approach, this course provides context for the FDA’s 2012 legislation for medical devices and how to implement best practices based on those revisions.
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.