PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE
FDA Quality Metrics—Latest Advances for FDA Regulated Companies from PHONIZE, USA
Now on Mobile Devices
PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE
FDA Quality Metrics—Latest Advances for FDA Regulated Companies from PHONIZE, USA
Now on Mobile Devices
Recent increases in field alert reports, recalls and drug shortages has mandated the attention of the industry. The FDA has been accused of focusing solely on modernizing plant controls and systems instead of properly regulating product quality.
To address issues and concerns, the FDA established the Office of Pharmaceutical Quality. This office exists to improve the scrutiny of brand-name, generic, and over-the-counter drugs, and is asking the industry to offer up better metrics for field investigations.
WHAT YOU WILL LEARN
This course will show you the context, the impact and the best practices related to the FDA’s New July 2015 “Request for Quality Metrics Guidance for Industry” & Safety and Innovation Act (FDASIA). 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.
AVAILABLE LEVELS
BASIC & INTERMEDIATE
TOPICS COVERED
- A summary of the FDA centers that are involved in Quality Metrics
- An explanation of the current quality control issues
- A step-by-step overview and guide focused on the FDA’s request to the industry for quality metrics
- Comprehensive insights on the most frequent citations from 21 CFR 210/211
- A primer on the FDA public meeting and its results
- Complete references

PERFECT FOR
- Quality Managers
- Quality Engineers
- Small business owners
- GxP
- Consultants
- Quality VPs
- IT VPs
“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 Quality Metrics provide context, improve overall product quality, reduce recalls and shortages, and improve manufacturing consistency.
Utilizing a risk-based approach, this course provides context for the FDA’s new July 2015 “Re-quest for Quality Metrics Guidance for Industry” & Safety and Innovation Act (FDASIA).
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.