8 Key cGMP Areas FDA Inspectors Seem to Focus On | FDAzilla Blog:
"As you prepare for your next FDA inspections, bear in mind some of the key focus areas, which were high priorities for FDA inspectors in the last few years—all driven by patient safety concerns, according to a top pharma executive:" . . .
Follow the link above to the list of 8 key areas.
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Showing posts with label priority. Show all posts
Showing posts with label priority. Show all posts
Tuesday, August 13, 2013
Wednesday, January 27, 2010
FDA CDRH Announces Strategic Initiatives
Updated Dec 7, 2015:
The link in the original post went stale. You might be interested in:
FDA CDRH Strategic Priorities and Updates
- - - - original post follows below - - - -
There's a lot here. I recommend you view this or download the FDA PDF, CDRH FY 2010 Strategic Priorities.
Here's what you'll find:
Executive Summary
Priority 1. Fully Implement a Total Product Life Cycle Approach
Strategy 1.1. Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions
Strategy 1.2. Improve Guidance and Regulation Development
Strategy 1.3. Develop a Cross-Center Compliance Strategy
Priority 2. Enhance Communication and Transparency
Strategy 2.1. Develop a Strategic Approach to Public Communication
Strategy 2.2. Improve Internal Communications
Strategy 2.3. Increase Transparency in Decision Making
Priority 3. Strengthen Our Workforce and Workplace
Strategy 3.1. Recruit, Develop, and Retain High-Quality Employees
Strategy 3.2. Leverage External Expertise
Strategy 3.3. Establish Pathways for Resolving Differences of Opinion
Strategy 3.4. Improve Internal Administrative Processes
Strategy 3.5. Make CDRH's White Oak Facilities More Workplace-Friendly
Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs
Strategy 4.1. Foster Development of Medical Devices to Respond to Unmet Public Health Needs
Strategy 4.2. Develop a Personalized Medicine Program
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store
The link in the original post went stale. You might be interested in:
FDA CDRH Strategic Priorities and Updates
- - - - original post follows below - - - -
There's a lot here. I recommend you view this or download the FDA PDF, CDRH FY 2010 Strategic Priorities.
Here's what you'll find:
Executive Summary
Priority 1. Fully Implement a Total Product Life Cycle Approach
Strategy 1.1. Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions
Strategy 1.2. Improve Guidance and Regulation Development
Strategy 1.3. Develop a Cross-Center Compliance Strategy
Priority 2. Enhance Communication and Transparency
Strategy 2.1. Develop a Strategic Approach to Public Communication
Strategy 2.2. Improve Internal Communications
Strategy 2.3. Increase Transparency in Decision Making
Priority 3. Strengthen Our Workforce and Workplace
Strategy 3.1. Recruit, Develop, and Retain High-Quality Employees
Strategy 3.2. Leverage External Expertise
Strategy 3.3. Establish Pathways for Resolving Differences of Opinion
Strategy 3.4. Improve Internal Administrative Processes
Strategy 3.5. Make CDRH's White Oak Facilities More Workplace-Friendly
Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs
Strategy 4.1. Foster Development of Medical Devices to Respond to Unmet Public Health Needs
Strategy 4.2. Develop a Personalized Medicine Program
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store
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