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FDA Quality System Regulations ISO 13485 Regulatory Inspections

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Title: FDA Quality System Regulations ISO 13485 Regulatory Inspections


1
FDA Quality System RegulationsISO
13485Regulatory Inspections
  • Copenhagen, Denmark
  • November 4, 2009
  • John Wilson, Jr., PhD, MPH
  • Senior Vice President, Clinical Trial Monitoring
    Services

2
First Principles
  • Several full-length seminar topics
  • Quality System Regulations (QSR)/ISO 13485
  • Quality System Inspection Technique (QSIT)
  • FDA Inspection Preparation
  • Necessarily brief and introductory version

3
Overview
  • Overview of the FDA QSR/GMPs
  • ISO 13485 as point of reference
  • FDA QSIT Guide
  • General Pointers for Managing FDA Inspections

3
4
Not Starting from Scratch
  • European community has a good understanding of
    ISO requirements, including ISO 13485
  • Many requirements of ISO 13485 and QSR are
    similar.

5
What is ISO 13485?
  • A standard, published in 2003, that represents
    the requirements for a comprehensive management
    system for the design and manufacture of medical
    devices.
  • Stand-alone document, harmonized with ISO 9001. A
    fundamental difference, however, is that ISO 9001
    requires the organization to demonstrate
    continuous improvement, whereas ISO 13485
    requires only that they demonstrate the quality
    system is implemented and maintained.

6
ISO 13485
  • Other specific differences include
  • Promotion and awareness of regulatory
    requirements as a management responsibility.
    Example of a market specific regulatory
    requirement is 21 CFR 820 Quality System
    Regulation for Medical Devices sold in the United
    States.
  • Focus on risk management activities
  • Specific requirements for inspection and
    traceability for implantable devices
  • Specific requirements for documentation and
    validation of processes for sterile medical
    devices
  • Specific requirements for verification of the
    effectiveness of corrective and preventive
    actions

7
What is QSR?
  • Quality System requirements for medical devices
    have been internationally recognized as a way to
    assure product safety and efficacy and customer
    satisfaction since at least 1983, and were
    instituted as requirements in a final rule
    published in 1996. The rule is promulgated at 21
    CFR 820.

8
QSR
  • The FDA has identified in the QS regulation the
    essential elements that a quality system shall
    embody for design, production and distribution,
    without prescribing specific ways to establish
    these elements. These elements include, but are
    not limited to
  • Quality System
  • personnel training and qualification
  • product design
  • documentation
  • purchasing
  • product identification and traceability at all
    stages of production
  • controlling and defining production and process

9
QSR (continued)
  • Quality System (continued)
  • defining and controlling inspection, measuring
    and test equipment
  • validating processes
  • product acceptance
  • controlling nonconforming product
  • instituting corrective and preventive action when
    errors occur
  • labeling and packaging controls
  • handling, storage, distribution and installation
  • records
  • statistical techniques
  • all overseen by Management Responsibility and
    Quality Audits.

10
QSR (continued)
  • QSR allows some leeway in the details of quality
    system elements.
  • It is left to manufacturers to determine the
    necessity for, or extent of, some quality
    elements and to develop and implement procedures
    tailored to their particular processes and
    devices.
  • For example, if it is impossible to mix up labels
    at a manufacturer because there is only one label
    to each product, then there is no necessity for
    the manufacturer to comply with all of the GMP
    requirements under device labeling.

11
21 CFR 820Applicability
  • Any finished device that is
  • Intended for human use
  • Manufactured
  • Imported
  • Or offered for import in all states and
    territories of the United States, D.C. and Puerto
    Rico.

12
Key Areas of Difference (QSR/ISO13485)
  • Customer Focus
  • Complaint Handling
  • CAPA
  • Records
  • Documentation
  • Labeling

13
Management Responsibility
13
14
Management Responsibility
14
15
Management Responsibility
15
16
Management Responsibility
16
17
Management Responsibility
17
18
A Look at Two Specific Areas
  • Individual approvals
  • Change procedures

18
19
Individual Approvals
  • There are numerous activities described in the
    QSR that require an approval by a designated
    individual, including
  • Design Master Records
  • Design Control Activities
  • Maintenance, Inspection, Validation and
    Calibration of Equipment
  • Process Validation and Performance
  • Acceptance Activities
  • Authorization for Non-conforming product
  • Decisions not to Investigate Complaints
  • Certification made by Management for records
    exempt from FDA inspection.
  • Labeling

19
20
Change Procedures
  • FDA places major emphasis on change management
  • Specs, method, process, procedural
  • Changes must be verified or validated as
    appropriate, and adequately documented
  • Frequent nonconformity if only following ISO
    13485

20
21
A Word about FDA Inspections
  • If I dont bring it up now
  • Plus, its important!

21
22
Consequences of Noncompliance
  • Product can be considered adulterated or
    misbranded
  • Various administrative and enforcement actions
  • CAPA
  • Warning Letter for serious violations
  • Failure to obtain approval to import into USA
  • Market withdrawal/recall

22
23
QSIT
  • Quality System Inspection Technique (QSIT)
  • Top Down versus Bottom Up
  • Top Down
  • Are procedures that address the QSR defined and
    documented?
  • Are the procedures being followed?
  • Bottom Up
  • Examine quality problems
  • Determine if deviations from QSR exist

24
QSIT
25
Systems Based Inspection
  • Four major subsystems
  • Management
  • Design Controls
  • CAPA
  • Production and Process Controls
  • Three other sub-systems are linked through review
    of the major ones listed above
  • Facility and Equipment Controls
  • Material Controls
  • Records/Documents/Change Controls

26
Management
  • Documented of the Quality Plan/Policy
  • Procedures for Quality System and Quality audits
  • Management Representative identified
  • Confirmation of Management Review
  • Confirmation that Quality audits are conducted as
    required

27
Design Control
  • Documented Design procedures and plans
  • Documentation of Design inputs or requirements
  • Documentation of Design outputs or specifications
  • Documentation of Design verification
  • Documentation of Design validation
  • Validation of software
  • Documentation of Risk Analysis at appropriate
    intervals
  • Documentation of Design Reviews
  • Documentation and verification of Design Transfer

28
Corrective and Preventive Action
  • Written CAPA Procedure
  • Investigation of root causes
  • Review of appropriate sources of data
  • Application of statistical analysis
  • Control of Non-conforming product
  • Documentation of CAPA
  • Communication with individuals involved in CAPA
  • Management review of CAPA

29
Production and Process Control
  • Control and monitoring of Processes
  • Handling of rejected or non-conforming products
  • Documentation that equipment is adjusted,
    calibrated and maintained appropriately.
  • Documented verification/validated of
    manufacturing processes.
  • Documented verification/ validation of Software
    (product and non-product).
  • Documentation that employees are qualified and
    trained.

30
FDA Inspections
  • Focus on
  • Class III devices
  • Implantable/ life supporting/ life sustaining
    devices
  • New device
  • History of significant violations in the past
  • Foreign manufacturers are typically contacted 2 -
    3 months in advance to schedule an inspection.
  • Its recommended that the Manufacturer forward
    the Quality System Manual for pre-inspection
    review.

31
Focus of Inspection Readiness
  • Inspection Team Established and Documented
  • Logistics Established
  • Program (Opening Meeting, Overview of Quality
    System, Key Issues)
  • Training
  • Mock Inspection (Facility Tour, Audit, etc.)
  • Review of Facilities

32
Maintaining Inspection Readiness
  • Conduct periodic facility inspections
  • Perform Mock Reviews, as appropriate
  • Maintain current documentation/ data/ information
    related to past inspections.

33
Inspection Readiness
  • Know how to interpret the regulations and apply
    them.
  • Conduct training for personnel.
  • Conduct regular mock inspections.
  • Review logistics
  • Identify and Coordinate Team
  • Perform Mock Interviews
  • Review Quality Policy and Supporting
    Documentation

34
John R. Wilson, Ph.D. Senior Vice
President jwlison_at_beaufortadvisors.com
Beaufort, LLC 500 East Main Street Suite
1301 Norfolk, Virginia 23510 1 (757)
383-6000 www.beaufortCRO.com
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