PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE
Medical Device and User Free Act III Overview for FDA Regulated Companies from PHONIZE
Now on Mobile Devices
PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE
Medical Device and User Free Act III Overview for FDA Regulated Companies from PHONIZE
Now on Mobile Devices
The MDUFA III took effect in 2012 and instituted new guidelines for medical device submission and rejection. Changes like these could cause companies to suffer unnecessarily due to ignorance and/or inability to adapt. This course clearly presents the facts about the new changes to regulation as they apply to medical device manufacturers and clinical trials, and comprehensive methods of properly implementing them.
WHAT YOU WILL LEARN
This course is designed to aid physicians, managers and quality assurance personnel in the formation of new procedures and processes to reduce the negative impact of regulatory changes and help your company prepare both strategically and tactically for regulatory interactions in the next five years.
AVAILABLE LEVELS
BASIC & INTERMEDIATE
TOPICS COVERED
- The history and context of the FDA’s MDUFA I to MDUFA III
- An overview of the FDA Safety & Innovation Act (FDASIA)
- A primer on process & policy improvements
- A full list of updated quantitative goals
- Projected MDUFA III review dates and times
- Key Highlights of the new regulation
- How best to implement all of the expected new processes
- A guide to hiring the best team to fulfill expectations
PERFECT FOR
- Clinical Trial Physician / Doctor
- Manager to Senior Director of;
- Regulatory Affairs
- Quality Assurance
- Clinical Research
- Data Management
- Data Monitoring
- Institutional Review Board
“Our quality managers enjoyed using PHONIZE and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Expertly formulated review and submission processes speed approval timelines, improve approval rates and reduce instant rejection.
Utilizing a risk-based approach, this course provides context for the MDUFA III and how companies can best incorporate new practices with reduced negative impacts on the company.
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.