Transcript 510(k) Data – Reprocessed SUDs

Topics - ‫( נושאים‬Lecture No. 1)
Sterile processing
Laboratories
Validation
/Qualification
Pharmaceuticals, API
Medical Devices, QSR
FDA
Design Control and Validation
for Medical Device
CFR
Computer Systems /Software
European GMP
Lect.7+8. 2009-10
Eli Solomon M.Sc,
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Medical Devices
)‫אביזרים ומכשירים רפואיים (אמ"ר‬

Pressure Manometers – ‫מדי לחץ דם‬

Thermometers - ‫מדי חום‬

O2 Administrating Apparatus -‫מכשיר הנשמת חמצן‬

Infusions Pump - )‫משאבות אינפוזיה (דיאליזה‬
Catheters - ‫קטטרים‬
Lect.7+8. 2009-10
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Medical Devices
)‫אביזרים ומכשירים רפואיים (אמ"ר‬

Implants – ‫שתלים‬

Endoscopes (Reusable) – ‫אנדוסקופים‬

Medical Gloves – ‫כפפות רפואיות‬

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Autoclaves, Depyrogenation Oven ‫אוטוקלבים‬
‫ותנורים‬
Diagnostic Kits - ‫ערכות זיהוי‬
Lect.7+8. 2009-10
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Medical Devices - The Tests
Sterility
Bacterial Endotoxin (LAL)
Microbial Limit Test (Bioburden)
Endotoxin Challenge during validation of
dry heat depyrogenation cycles
Lect.7+8. 2009-10
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Medical Devices - The Tests
Spore challenge during autoclave / EtO /
Gamma (γ) radiation validation
Media Fill
Filtration Validation
Lect.7+8. 2009-10
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Medical Devices
Microbial Contamination - Top 10
Raw Material Contamination
Water Contamination
Water System were not validated
Absence of Method Validation
Absence of Environmental Monitoring Program
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Medical Devices
Microbial Contamination -Top 10
Improper Sanitation of Equipment
Improper Personal Training
Improper Testing Facilities
Absence of Functional Microbial Limit Test
(MLT) Program
Improper Sanitation of Water Systems
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Personnel
Media Fills
QA/QC
* Includes
both design
Lect.7+8. 2009-10
and maintenance
Facility
&
Room*
Aseptic
Processing
Line*
Daily
“Sterility
Assurance”
Disinfection
Practices
Eli Solomon M.Sc,
Process
•personnel flow
•material flow
•layout
HVAC/
Utilities*
Deviations &
Environmental
Control Trends
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Design Control and Validation for
Medical Devices
Lect.7+8. 2009-10
Eli Solomon M.Sc,
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Medical Devices
http://www.fda.gov/cdrh/qsr/contnt.html
Lect.7+8. 2009-10
Quality Systems
Design Controls
Process Validation
Personnel
Buildings and Environment
Equipment and Calibration
Device Master Record
Document and Change Control
Purchasing and Acceptance Activities
Labeling
Product Evaluation
Packaging
Storage, Distribution, and Installation
Complaints
Servicing
Quality Systems Audits
Factory Inspections
AppendixEli(Index
of appendices
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Medical Devices - Glucometer
www.fda.gov/cdrh/comp/designgd.html#_Toc382720781
SECTION A.
SECTION B.
SECTION C.
SECTION D.
SECTION E.
SECTION F.
SECTION G.
SECTION H.
SECTION I.
SECTION
J.
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GENERAL
DESIGN AND DEVELOPMENT PLANNING
DESIGN INPUT
DESIGN OUTPUT
DESIGN REVIEW
DESIGN VERIFICATION
DESIGN VALIDATION
DESIGN TRANSFER
DESIGN CHANGES
DESIGN EliHISTORY
FILE (DHF)
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Medical Devices - Glucometer
ORGANIZATIONAL RESPONSIBILITIES
Assessing new product ideas
‫הצעות והערכות למוצר חדש‬
Training and retraining of design managers and
design staff
‫הנחיות והדרכות של מנהלי תכן המוצר‬
Use of consultants
Lect.7+8. 2009-10
Eli Solomon M.Sc,
‫קבלת ייעוץ חיצוני של מומחים‬
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Medical Devices – Glucometer
Evaluation of the design process
‫ מכשור וציוד‬,‫ לוחות זמנים‬,‫ כוח אדם‬,‫במוצר החדש יש להעריך (לאמוד) את תכן התהליך (חו"ג‬
)‫קיים‬
Product evaluation, including third party
product certification and approvals
‫הערכת המוצר כוללת גם ספקים וקבלני משנה מאושרים‬
Patenting or other means of design protection
‫הגנה על הקניין רוחני‬
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Medical Devices - Glucometer
ORGANIZATIONAL RESPONSIBILITIES
•
•
•
•
•
•
•
risk management
device reliability
device durability
device maintainability
clinical evaluations
device serviceability
document controls
human factors engineering
Lect.7+8. 2009-10
Eli Solomon M.Sc,
Use of consultants
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Medical Devices - Glucometer
ORGANIZATIONAL RESPONSIBILITIES
•
•
•
•
•
•
software engineering
use of subcontractors
use of standards
use of company historical data
configuration management
compliance with regulatory requirements
Lect.7+8. 2009-10
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Medical Devices - Glucometer
TASK BREAKDOWN.
• The major tasks required to develop the product
• The time involved for each major task
• The resources and personnel required
• The allocation )‫ (להקצות‬of responsibilities for
completing each major task
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Medical Devices – Glucometer
• The basic information necessary to start each
major task and the interrelationship between tasks
• The form of each task output or deliverable
• Constraints, such as applicable codes, standards,
and regulations
).‫ קודים סטנדרטים ותקנים‬:‫(לאכוף‬
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Medical Devices - Glucometer
The fishbone diagram:
1. Breaks the problem into bite size pieces
2. Display many possible causes in a graphic manner
3. Shows how various causes interact
In consideration we should have the 5 M and E
Material
Measurement
Lect.7+8. 2009-10
Machine
Man
Environment
Method
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Medical Devices (Ref.)
)‫אביזרים ומכשירים רפואיים (אמ"ר‬

http://www.fda.gov/cber/gdlns/steraseptic.pdf

http://www.fda.gov/cdrh/qsr/05prsnl.html

http://www.fda.gov/cdrh/dsma/gmpman.html

http://www.fda.gov/cdrh/qsr/08dmr.html

http://www.fda.gov/cdrh/comp/designgd.pdf
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