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QSR Fundamentals
Complying with FDA's Medical Device 21 CFR
820 Quality System Regulations
(1 day course)
Course Content:
- FDA’s Evolving Approach to
Quality Systems
- Scientific foundations of
quality systems
- Key quality system elements
according to ISO and FDA
- Speaking the lingo:
important cGMP terms and definitions
- Introduction to FDA’s Quality
Rules for Medical Devices
- Core principles
- Quality and compliance: two
sides of the same coin
- Seven FDA-recognized
subsystems of your quality system
- ISO/ICH Approaches to Quality
Systems
- Comparison of international
standards to FDA expectations
- ISO 9001:2000 quality system
requirements
- Relationship to ISO 13485:
2003
- QSR Management Review and
Control (Subpart B)
- Management and executive
responsibilities
- Developing a Quality Policy
- Allocating adequate
resources
- QSR Design Controls/System
Development (Subpart C)
- Tools for design control
- Research vs. design
- Design verification and
validation
- QSR Production and Process
Controls (Subparts G, O)
- Tools for controlling and
monitoring processes
- Process validation
- Computerized system
validation, including validating off-the-shelf software
- QSR Corrective and Preventive
Actions – CAPA (Subparts J, I, N)
- Difference between
correction vs. corrective action
- Examples of preventive
action
- Evaluating CAPA sources
- The Yin/Yang of Method
Design/CAPA
- FDA’s trending requirement
- ISO 9001:2000 trending
requirement
- QSR Laboratory Controls (Subpart
I)
- Process tasks for laboratory
controls
- Documenting laboratory
operations
- Validating laboratory test
methods
- Conducting Failure
Investigations
- Importance of identifying
root cause
- Seven basic investigation
tools you should know
- Best practices for reducing
failures
- QSR Documents, Records and
Change Control (Subparts D, M)
- Assuring changes are
reviewed and approved
- Tools for change control
- QSR Facility and Equipment
Controls (Portions of Subpart G)
- Minimizing adverse impacts
of manufacturing environment
- Tools for facility and
equipment control
- Key environmental controls
- QSR Material Controls (Subparts
E, F, H, K, L)
- Evaluating suppliers,
contractors and consultants
- Tools for material controls
- How to Prepare for an FDA QSR
Inspection
- Understanding FDA’s Quality
System Inspection Technique (QSIT)
- Quality system objective
evidence the inspector will want to see
- Examples of systems-based
questions to use to prepare
- FDA Enforcement Priorities
- Understanding FDA’s mindset
- Inspection Observations and
Reports
- Consequences of
non-compliance
- Recent trends in FDA 483
observations
- Practical suggestions
surviving an inspection
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