Transcript Slide 1

FDA Medical Device
Quality Systems Compliance
Quality Systems Compliance
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Agenda
• Introductions, Attendance Sign in
• Domestic and International Quality Systems
• Food and Drug Law
• Organization of the FDA
Break ( 15 min)
• Procedures
• FDA Quality Systems Regulations ( 21 CFR 820)
Lunch
• Labeling
• Complaint Handling
• Record Keeping
Break (15 Min)
• FDA Quality Systems Audits
• Exam
• Course Evaluations
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US and European Regulatory
Systems
US
European System
Congress Passes Laws
FDA Writes Regulations
European Commission
Issues Directives
Harmonized Standards adopted
by the Member Countries
Companies Develop Quality
Systems Procedures
Member Countries identify
independent Notified Bodies
FDA Audits for Compliance
to Regulations
Notified Bodies Audit for
Compliance to the Directive and
Harmonized Standards
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US vs European Laws
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US
Food, Drug and
Cosmetics Act
Medical Device
Amendments (1976)
Safe Medical Devices
Amendments (1990)
FDAMA (1997)
Europe
• Medical Device
Directive (MDD) 1993
• Active Implantable
Medical Device
Directive (AIMD) 1990
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US vs. European Quality
System Requirements
US
• 21 CFR 820
(Also known as the
QSR)
Europe
• Essential Requirements
• Harmonized Standards
• ISO 13485
• Guidance Documents
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Background of the FDA
• Biologics Control Act. 1902
• The Pure Food and Drug Act-1906
• Food Drugs and Cosmetics Act -1938
– Medical Device Amendments to the FDCA –
1976
– Safe Medical Devices Act- 1990
– FDAMA- 1997
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Offices of Medical Product Regulation within the
U.S. Food and Drug Administration (FDA)
CBER
CDRH
CDER
Center for Biologics
Evaluation and Research
Center for Devices and
Radiological Health
Center for Drug
Evaluation and Research
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Definitions
Drugs
Devices
Biologics
“[an article] intended for use in the diagnosis, cure, mitigation, treatment,
or prevention of disease . . . [or] . . . intended to affect the structure or
any function of the body” FD&C Act, §201(g)(1)
“. . . An instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar related article . . . intended for
use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment or prevention of disease . . . or intended to affect
the structure or any function of the body . . . and which does not
achieve any of its primary intended purposes through chemical
action within or on the body . . . and which is not dependent upon
being metabolized for the achievement of any of its primary
intended purposes” FD&C Act, §201(h) (emphasis added)
“ . . .any virus, therapeutic serum, toxin, anti-toxin, vaccine, blood,
blood component or derivative, allergenic product, or analogous
product applicable to the prevention, treatment or cure of diseases or
injuries” PHS Act, §351(a)
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FDA Center Responsibilities
CBER
CDRH
Blood
Products
Stethoscopes
Zocor
MRI Scanners
Viagra
Vaccines
Hemodialysis
Machines
Tylenol
Surgical
Instruments
Penicillin
Gene/Cell
Therapy
Stem Cell
Research
CDER
Celebrex
Microwave
ovens
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Regulations
CBER
Biologics
CDRH
Devices
Blood
•21 CFR 21 CFR
820 QSR (GMP)
•21CFR 606
•21 CFR 56 (IRB’s)
CLIA
•21 CFR 58 (GLP)
21CFR 1270, 1271
(tissue)
•21CFR 11 (Electronic
records)
21 CFR 58 (GLP)
•21 CFRR 800-1050
(devices)
•21 CFR 600/601/610
21CFR 11 (electronic
records)
CDER
Drugs
• 21 CFR 56 (IRB’s)
• 21 CFR 58 (GLP)
• 21CFR 11
(Electronic records)
•21 CFR 210, 211
(Drug GMP’s)
• 21 CFR 312 (IND)
• 21 CFR 314 (NDA)
•21 CFR 807 (510(k))
•21 CFR 812 (IDE)
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Class Exercise - FDA Organization
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Which division of the FDA has authority over the
following products?
Blood banks
Bandages
Computer terminals
Bone graft material
Pre-filled antibiotic syringes
Lasers for eye surgery
Artificial skin graft materials
Contact Lenses
Dog and Cat Food
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Quality System
A Medical Device Quality System is
designed to assure that products are Safe
and Effective for their Intended Use
and
Consistently meet the specifications as
defined by results of clinical and/or
detailed technical design and validation
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Quality Control
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Quality System Basics (ctd)
• Quality is everyone’s responsibility
• Quality has measurable attributes
• Specifications are the  of a Quality
System
• Documented policy and procedures
contribute to consistency
• Quality planning is essential
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Quality Systems Basics (ctd)
• Clinical evaluation is the basis for safety and
effectiveness
• Design Controls and validation assure that
designs meet clinical expectations and
specifications
• Process validation assures consistency
• Identification, segregation and control of
materials and products prevents mix-ups
• Documentation control is essential
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Quality System Basics (ctd)
• Corrective and preventative action
systems foster continual improvement
• Labeling is important
• Internal and external (FDA) auditing
keeps quality systems up to date
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The Documentation Pyramid
Quality Manual
Procedures
Work Instructions
Records
(forms, notebooks, travelers)
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Important Terms
• Device Master Record
(DMR)• Device History Record
(DHR)
• Design History File (DHF)
• Technical File
• Complaint
• Corrective Action
• Controlled Document
• Engineering Change Order
(ECO)
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Labeling
Verification
Validation
Traceability
Medical Device Directive
(MDD)
• Essential Requirements
• Notified Body
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Procedures
FDA 21 CFR 820 requires
following written procedures
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Group Exercise: Draw a House
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Draw A House
1. Read all instructions before beginning to draw the house
2. Draw your house in the lower ½ of the page
3. Begin by drawing a rectangle approximately 4 inches wide by 3 inches tall,
with the long side parallel to the bottom edge of the paper. The bottom of the
rectangle should be 1 inch from the bottom of the paper.
4. Locate the center of the top edge of the rectangle. Put a small dot at that point.
5. Put a small dot 1 ½ inches above the dot you just made. This dot will be
above the rectangle.
6. Draw a line from the new dot to each edge of the top of the rectangle.
7. Draw a door in the center of the rectangle. The door should be 3/4 inch wide
by 2 inches tall. The bottom of the door should touch the bottom of the
rectangle.
8. Draw a window, approximately 1 inch square on each side of the door, 1 inch
from the bottom of the rectangle. Hint: A average thumb is about 1 inch wide
at the knuckle. The edge of each window should be ¼ inch from the nearest
edge of the door.
9. Draw 4 panes of glass in each window by making a cross in each window.
Each pane should be the same size.
10. Draw a chimney on the left side of the roof of the house. The chimney should
be parallel to the left wall of the rectangle, touching the roof. The chimney
should be ½ inch wide by 1 inch tall and go straight up.
11. Draw some smoke coming from the chimney. A squiggly line will represent
smoke.
12. Put your pencil down when you are finished.
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Quality System Processes
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Management Controls
Design Controls
Materials Controls
Document Controls
Purchasing Controls
Production and Process Controls
Facilities and Equipment Controls
Document, Record and Change Controls
Corrective and Preventative Action
Labeling Controls
Handling, Storage, and Distribution controls
Servicing Controls
Statistical Techniques
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Management Controls
• Possible careers
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Internal Auditor
External Auditor
Quality Specialist
Quality Systems
Trainer
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Who is an Auditor?
An Auditor is someone who comes in
after the war is lost to bayonet the
wounded…
Anon.
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Management Controls
21CFR 820 Subpart B
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Quality Policy Defined
Management Representative
Management Review
Quality Systems Procedures
Quality Systems Audits
Trained Personnel
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Design Controls
• Possible Careers
– Design Engineer or
Technicians
– Quality Test
Technicians
– Clinical Specialists
– Documentation
Specialists
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Design Controls
A Medical Device Quality System is
designed to assure that products are
Safe and Effective for their Intended
Use
and
Consistently meet the specifications as
defined by results of clinical and/or
detailed technical design and validation
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Design Controls
• A Design Control System is intended to design
products which
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provide safe and effective medical devices,
meet the clinical needs of the intended patient population,
provide outstanding value to the user,
satisfy the needs and expectations of our customers.
• Phased approach to product development
• Each phase has deliverables
• Design reviews are the checkpoints
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Design Control Elements
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Design Planning
Design Input (Requirements)
Design Output (Specifications)
Design Reviews (Technical)
Design Verification (Meets Specifications
Design Validation (Meets clinical needs)
Design Transfer- (Moves from Design to
Manufacturing)
• Design Changes (Formal Process)
• Design History File (DHF)
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Design Planning
• Feasibility Studies
• Risk Assessments
• Project Plan Defines Interfaces with
Others
• Stage-Gate Methodology
• Constantly Changing
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Design Input
• Where
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Customers
Technical Papers
Medical experts
Service people
• What
– Intended Use
– Technical Requirements
– Safety Issues
• How
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Documented
Approved
Filed
Formal Change Control System
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Design Output
• Final Design Specifications
– Quantitative
– Documented
– Approved
• Final Risk Assessments
• Clinical Testing May Be Needed
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Design Reviews
• Planned Formal Technical Reviews
• Independent Member of Review Team
• Documented
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Design Verification And Validation
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Verification - Meets Specification
Validations - Meets Intended Clinical Use
Written Procedure Required
Testing Must be Documented, Reviewed
and Approved
• Software Must be Validated
• Manufacturing Processes Must be
Validated
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Design Transfer
• Design moves from R&D to Manufacturing
• Manufacturing and Production
Specifications are Documented
• Manufacturing IQ, OQ, PQ
– IQ - Installation Qualification (Equipment)
– OQ - Operational Qualification( 1st ones meet
specs)
– PQ - Performance Qualification (Consistently
repeatable)
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Design Changes
• All changes to the design after release
must be controlled (Engineering Change
Control)
– Re-validation may be needed
• Continues for the Life of Product
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Design History File
• Record of the
Development Process
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Plans
Specifications
V&V Test Results
Design Reviews
Changes to the Design
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Class Exercise-Design Controls
Dr. Bright and Dr. Idea have found a novel way to produce a machine
to determine if a heart attack patient has additional blockage in the
coronary arteries that may be caused by the surgical bypass
procedure (CABG). The machine non-invasively measures arterial
flow by using Doppler sonar to determine if the arteries are blocked. It
can be used in a patient’s home, by itself, on post heart attack
patients who may be at risk for additional heart attacks. It transfers
the data to a monitoring station at a EMS facility for 24/7 monitoring.
They have formed a company (The Bright-Idea Company), built a
prototype and tested it in the lab on sheep and pigs. It worked great.
Now they want to begin marketing it for use on humans.
1. Is the machine a medical device?
2. What steps should Dr. Bright and Dr. Idea take before they can begin
marketing the machine?
3. What documents do they need to have on file?
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Manufacturing
and
Servicing the Product
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Manufacturing and Service
A Medical Device Quality System is
designed to assure that products are Safe
and Effective for their Intended Use
and
Consistently meet the specifications as
defined by results of clinical and/or
detailed technical design and validation
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Documents Controls
• Career Opportunities
– Documentation
Control Specialist
– Change Order
Coordinator
– Drafter
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Documents Controls
• Controlled System
• Review and Approval Required
– Signature, Date
– Authorized Personnel Listed in a Procedure
• Engineering Change Order Process (ECO)
• Electronic Records Require Special
Security
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Purchasing Controls
• Career Opportunities
– Purchasing Agent
– Buyer
– Supplier Auditor
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Purchasing Controls
• Written Procedures Required
• Supplier Selection Process
– Approved Supplier List
• Purchase Orders
– Detailed Specifications Needed
– Supplier is Required to Have Current
Specifications
• Supplier Auditing
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Identification and Traceability
• Career Opportunities
– Receiving and
Inspection
Coordinators
– Shipping Coordinators
– Quality Technicians
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Identification and Traceability
• Unique Identification of Product Through
All stages of Receiving, Production,
Installation, and Service
• Separate Accepted (Good) from NonConforming (Bad)
• Implants or Life Sustaining Product
Requires Traceability to the User
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Production and Process Controls
• Career Opportunities
– Calibration Technician
– Maintenance
Technicians
– Change Coordinators
– Trainers
– Process Validation
Technicians
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Production and Process Controls
• Written Instructions (SOP’s) Required
• Environmental Controls
– Clean Rooms
• Personnel
– Health, Cleanliness, etc.
• Contamination Control
• Equipment
– Maintenance Schedules
– Software Validation Required in Process Equipment
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Inspection, Measurement and Test
Equipment
• Routine Calibration of Measurement
Equipment
• Reference Standards Must Be Maintained
• Records Must Be Kept In Secure Areas
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Acceptance Activities
• Career Opportunities
– Inspection Technician
– Test Technicians
– Non-conforming
product coordinator
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Acceptance Activities
• Written Procedures are Required for all
Inspection and Test Activities
• Receiving Inspection
• In-Process Inspection and Test
• Final Inspection and Test
• Records
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Non-Conforming Product
• Non-conforming- Def: Does not meet
Specifications
• Segregation, Identification and Status of
Nonconforming Product is Required
• Material Review Board (MRB)
• Rework, Retest and Disposition
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Typical Inspection, NCMR, and Rework Process
C:\ My Document s\ QA Training\ NCMR-Reprocess.abc
(The Happy Path)
Incoming
Inspect ion
SP-00050
SP-00031
ECO
Rework, Repair, Update
disposition
FM00026
Special IP
IP's
Accept /
Reject
FM 00032
NCMR
SP00022
Reject
Material
QA
Quarrentine
MRB
St ores
SP00020 Material
control Process
Ret urn t o
Vendor
Sort / Rework
Vendor Not ificat ion
Correct ive
Act ion Request
FM 00036
Reprocess
Order
Use As Is
In Process
(WIP)
SP 00044 Travelers
SP 00004 In-process
inspection
FM 00049 (MO)
Scrap
Log
Accept /
Reject
Reject
Use as is
rationale
FM 00043
Final QA
Release
SP-00042
Accept /
Reject
Scrap
FM 00035
Vendor
replacement
Debit Memo
Re-Inspect
FM 00029
Debit Memo
Accept/
reject
Reject
CPAR/ CPAN
required?
Reject
Receive Correcive
Yes Action (CPAN or
Vendor CAR)
Accept
Finished
Goods
NO
Ret urn
mat erial t o
St ores,
in-process,
Close NCMR File
in Quality Data
files
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Corrective and Preventative Actions
(CAPA)
• Career Opportunities
– Quality Analyst
– Quality Engineer
– Complaint Coordinator
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Corrective and Preventative Actions
(CAPA)
• Includes Internal and External Actions
(Complaints to be covered after lunch)
• Corrective Actions- Actions Taken After
Occurrence of the Event to Prevent
Reoccurrence
– Process Analysis
– Failure Analysis
– Procedure Review
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Corrective and Preventative Actions
(CAPA)
• Examples of Corrective Actions
– Review of Field Failures
– Review of NCMR
– Procedure Reviews
• Corrective Actions Should be Validated to
Assure They Work
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Corrective and Preventative Actions
(CAPA)
• Preventative Action- Actions Taken to Prevent a
Problem from Occurring
– Process Validations (IQ,OQ,PQ)
– Trend Analysis of Complaints, Repairs
– Internal Production Rework Trend Analysis
• (NCMR DATA)
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Supplier Audits and Reviews
Highly Accelerated Stress Screening Testing (HASS)
Highly Accelerated Life Testing (HALT)
Market Information Review from Competitors
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Corrective and Preventative Actions
(CAPA)
• Communicate the Results of Analysis
• Management Reviews must Include
CAPA Information
• Documentation of Actions is REQUIRED
– Indication of the effectiveness of the Quality
System
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Labeling and Packaging
• Written Procedures Required
• Label Integrity– Does the label remain legible for product life
• Label Inspection
– Control of labels required
• Label Storage
– Secure area
– QA release
• Labeling Operations
– Assure that labels are not mixed up
– Recalls of FDA regulated product can be initiated by mislabeling
• Serial Numbers
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Labeling and Packaging
• Packaging must be Designed to Assure
That Products Are Protected During
Transit and Storage
– Shipping testing
– Environmental testing (Temperature, Humidity)
– Specialized labeling of the package may be
needed
• Sterile Packaging has Special
Considerations
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Handling, Storage, Distribution and Installation
• Career Opportunities
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Material Handlers
Stockroom Personnel
Shipping Personnel
Field Installation
Traffic Managers
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Handling, Storage,
Distribution and Installation
• Official Release (QA) from Production to
Storage (Stockroom) Required
• Mix-Ups Must be Prevented
• Prevention from Damage or Deterioration
– Shelf Life
– Stock Control-FIFO
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Handling, Storage, Distribution and
Installation
• Procedures Required to Assure that Only
“GOOD” Product is Released for Distribution
• Records of Following must be Kept by
Manufacturer
– Name and Address of Consignee (Company or
Person who Receives Product)
– Quantity shipped
– Date Shipped
– Serial, Lot Numbers Shipped
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Handling, Storage, Distribution and
Installation
• Installation Instructions Required (IQ)
• Installation of Equipment Must Be Verified
• Records Kept (if done by Mfgr.)
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Records
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General
– Records Must be Legible
– Security maintained
– Available for Life of Product
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(min) 2 years past shipping date
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Records
• Device Master Record (DMR)( Recipe)
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Design Specifications
Process Specifications
QA Procedures
Packaging Info Records
Labeling Info
Installation and Maintenance Info
• Device History Record (DHR)(As really Built)
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Date of Manufacture
Quantity Manufactured
Quantity Released for Distribution
Acceptance ( Test) Records
Primary Labeling Information
• Quality System Record (QSR)
– Quality Manual, Management Review Procedures, SOP’s, Generic
Training Procedures, Other Non-device Specific Quality Procedures
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Service
• Career Opportunities
– Service Technicians
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Service
• Written Procedure For Service Required
• Testing Post Servicing Required
– Record is part of the DHR
• Records Must Contain
– Name and SN of Device
– Date and Person Servicing Device
– Service preformed and Test Results
• Service Information Must Reviewed for
Complaints
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Statistical Techniques
• Valid Statistical Plans must be used for
all sampling and testing to verify
conformance to specifications
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Class Exercise
Manufacturing and Service
The Bright-Idea Company received approval to market the machine .
They have produced approximately 1000 of the machines, shipped 700 to
their customers.
One afternoon, the final tester began to notice that the machines did not
always work the way they were supposed to at the final test station. He was
rejecting about 50% of them.
The design engineer in charge found that there was a sticky valve in about
50% of one of the lots of valves they received two months ago. It was hard
to tell if the valves would always fail or not, because the problem was
intermittent.
350 machines had been made using the lot with the defective valves.
You are the Quality Engineer responsible for Corrective Actions. What
steps should you take next?
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Labeling
• Career Opportunities
– Label Designer
– Graphic Artist
– Technical Writer
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Labeling
21 CFR 801
• Section 201(k) defines "label" as a:
"display of written, printed, or graphic matter upon the immediate
container of any article..." The term "immediate container" does not
include package liners. Any word, statement, or other information
appearing on the immediate container must also appear "on the
outside container or wrapper, if any there be, of the retain package of
such article, or is easily legible through the outside container of
wrapper."
• Section 201(m) defines "labeling" as:
"all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanying such article" at any time while a device is held for sale after
shipment or delivery for shipment in interstate commerce.
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Over The Counter (OTC)
Device Labeling
• Principal Display Panel 21 CFR 801.60
The principal display panel is that portion of the label which is
intended to be displayed, presented, shown, or examined under
customary conditions for retail sales.
• Statement of Identity 21 CFR 801.61
The statement of identity of the device must be listed on the
principal display panel.
– It must list the common name
– Indications for use
– Bold type,
– Reasonably sized generally parallel to the base of the package
• Net Quantity of Contents Statement 21 CFR 801.62
The label of an over-the-counter (OTC) device in package form must
contain a statement of net quantity of contents in terms of weight,
measure, numerical count; or a combination of numerical count and
weight, measure.
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Prescription Device Labeling
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Prescription Device 21 CFR 801.109
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A device which, because of any potentiality for harmful effect, or the supervision of
the method of its use, or the collateral measures necessary to its use is not safe
unless under a practitioner licensed by law to direct use this device, and hence for
which "adequate directions for use" cannot be written, is exempt from such provided:
– - It is in the possession of either a licensed practitioner or persons lawfully
engaged in the manufacture of distribution of the product;
– - Its labeling bears an Rx statement, i.e., "Caution: Federal law restricts this
device to sale by or on the order of a (Insert name of physician, dentist or other
licensed practitioner;"
– - Its labeling bears information for use including, indications, effects, routes,
methods, and frequency and duration of administration, and any relevant
hazards, contraindications, side effects, and precautions under which the device
can safely be used; and
– - All labeling other than labels and carton bears the date of issuance or date of
the latest revision.
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Rx Medical Device LabelingGeneral Requirements
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Intended Use
Indications for Use
Contraindications for Use
Warnings, Cautions
Description of the Device
User Instructions
Specifications
Corrective Actions (Troubleshooting)
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FDA Actions for Mislabeling
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Warning Letters
Mandatory Recall
Injunctions to Stop Shipment
Seizure
Fines and Imprisonment
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FDA Legal Actions
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SEC. 303. [21 U.S.C. 333] (a)(1) Any person who violates a provision of section 301 shall be
imprisoned for not more than one year or fined not more than $1,000, or both.
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Notwithstanding the provisions of paragraph (1) of this section, if any person commits such a
violation after a conviction of him under this section has become final, or commits such a violation
with the intent to defraud or mislead, such person shall be imprisoned for not more than three
years or fined not more than $10,000 or both.
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Knowingly distributing drugs/devices in violation of section 503(e)(2)(A), shall be imprisoned for
not more than 10 years or fined not more than $250,000, or both.
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Any manufacturer or distributor who distributes drug/device samples by means other than the mail
or common carrier whose representative, during the course of the representative’s employment or
association with that manufacturer or distributor, violated section 301(t) because of a violation of
section 503(c)(1) or violated any State law prohibiting the sale, purchase, or trade of a drug
sample subject to section 503(b) or the offer to sell, purchase, or trade such a drug sample shall,
upon conviction of the representative for such violation, be subject to the following civil penalties:
(A) A civil penalty of not more than $50,000 for each of the first two such violations resulting in a
conviction of any representative of the manufacturer or distributor in any 10-year period.
(B) A civil penalty of not more than $1,000,000 for each violation resulting in a conviction of any
representative after the second conviction in any 10-year period.
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Class Exercise- Labeling
• Review of Respironics REMStar® Heated
Humidifier labeling for:
– Indications for use
– Contraindications
– Prescription Statement
– Description
– Corrective Actions
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Complaints
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Complaint Definitions
• Any written, electronic, or oral communication
that alleges deficiencies related to the
– Identity
– quality
– durability
– reliability
– safety
– effectiveness
– or performance
of a device after it is released for distribution."
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World of Complaints
US
MDR
EU
Incidents
and near
incidents
Some Definitions:
Complaint: An expression of dissatisfaction concerning a product or
services
Quality Complaint: Any report that a product failed to meet its
specifications for intended use, safety, performance or reliability; caused
or contributed to a patient’s death; malfunctioned and could have caused
or contributed to a death, or that the labeling was misleading or
misbranding the product.
Reportable Quality Complaints
US- Medical Device Reports- Report required if a death or serious
injury occurred or could occur in similar circumstances due to
a malfunction or improper labeling.
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Sources of Complaints
Complaints that shall be processed according to
the GMP requirements may be received from:
• Customers by letter, credit memo, returned
goods form, or phone;
• A manufacturer's representative, or other
employees;
• The MedWatch voluntary reporting program;
• A service or repair request;
• Journal articles; or
• The FDA
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What to do
1. Remain Calm
2. Gather details of the complaint:
a. Date complaint received, recipient’s name, recipient’s
department, phone and extension number, if applicable.
b. Complainant’s information: name, address, telephone, and fax
number if applicable.
c. Customer information: customer name, contact person,
customer address, telephone, and fax number if applicable.
d. Patient information: patient name, date product placed in
service, date of problem/event.
e. Device information: device name, model number, serial/lot
number.
f. The form of communication of complaint: written, electronic,
oral.
g. Details of complaint: Verify that enough information has been
given in order that an analysis can be made of the type of
complaint, specific malfunction or deficiency of product or
service, or problem which has occurred.
h. If product has been returned, verify that an authorized RA
number has been assigned
i. If the product has not been returned, try to have the product
placed in Quarantine by the hospital, and arrange for return
j. Follow Up on Complaints
k. Link to CAPA system
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Complaints-MDR
• Medical Device Report (MDR)-The MDR
regulation requires that all manufacturers
of medical devices notify FDA when they
become aware of a death or serious injury
that may have been caused or
contributed to by one of their marketed
devices and/or any malfunction of one of
their devices which, if it were to recur,
would be likely to cause or contribute to a
death or serious injury.
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Class Exercise
Sandy Bright is Dr. Bright’s daughter. One day
she was at a neighbor’s house (Ms. Consumer)
when the machine Dr. Bright’s company made
stopped working while Ms. Consumer was using
it and Ms. Consumer had to go to the hospital.
Ms. Consumer told Sandy to tell her Dad about
the problem. Sandy told her Dad the next
morning.
What Should Dr. Bright do and when?
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FDA Audits
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FDA Audits
• Career Opportunities
– FDA Compliance
Officer
– FDA Consumer Safety
Officer
– Internal Auditor
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FDA Audits of a Device
Manufacturer
• Types
– QSR-Risk Based Approach
– Targeted- Based on a Complaint/Recall
•
•
•
•
Establishment must be registered
May Be Unannounced
FDA issues a Form 482-Notice of Inspection
If problems- FDA issues a form 483-Notice of
Observations
• Possible Warning Letter if not corrected.
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Manufacturer’s Responsibilities
•
•
•
•
•
•
•
Have Written Policy for FDA or other External Audits
Have Records Organized
Have an Escort at all Times
Have a Separate Room for the Auditor
Bring Information to Auditor
Be Courteous
Don’t offer any “bribes”
–
–
–
–
Lunch
Trips to Hawaii
Baseball Game Tickets
Company Party
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Employee Responsibility
•
•
•
•
•
Remain Calm
Answer Questions Truthfully
Don’t Volunteer Information
Refer to Procedures
If in Doubt, Refer to Supervisor/Escort
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Questions
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Test
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