PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE PLAYBOOK™
Risk Management and Drug Surveillance for FDA Regulated Companies from PHONIZE
Now on Mobile Devices
PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE PLAYBOOK™
Risk Management and Drug Surveillance for FDA Regulated Companies from PHONIZE
Now on Mobile Devices
It is vital to a company’s success to be able to recognize risk management and surveillance tools, and evaluation and reporting procedures used in the drug manufacturing industry—information and training that is provided in this course.
WHAT YOU WILL LEARN
This course will show you a clear, effective approach to implementing best practices to align your company with FDA risk management and surveillance processes.
This comprehensive course provides clear guidance to managers and quality assurance personnel on how to follow regulation expectations and formulate their own risk management practices based on existing reporting and surveillance programs.
AVAILABLE LEVELS
BASIC & INTERMEDIATE
TOPICS COVERED
- Basic concepts of the drug registration and listing process, including DUNS number
- An overview of the Adverse Drug Experience (ADE) Reporting Program, including the FDA CDER’s ADE Training Video
- An introduction into the Drug Quality Reporting System (DQRS)
- Comprehensive risk evaluation and mitigation (REMS) strategies
- Elements to Assure Safe Use
- Implementation of REMS
- Enforcement of REMS
- Misbranding and Civil Penalties

PERFECT FOR
- CEOs
- VPs
- Hospital Administrators
- Doctors and Nurses
- Regulatory, Quality and IT VPs
- Regulatory Affairs professionals
- Quality Managers
- Quality Engineers
- Small business owners
- GxP practitioners
- Consultants
“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 risk management processes provide better safety, improve procedures and reduce downtime.
Provides clear information on all important FDA drug-related registration and reporting processes.
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.