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FDA Compliance

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					FDA Compliance
What does it mean for your business?
Enforcement Power of FDA
•  Report of Observations:
       – FDA Form 483
•  Warning Letters
•  Seizure
•  Injunction/Consent Decree
•  Criminal Prosecution
•  Fines
•  Mandatory Recalls
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Cost of Noncompliance

•  Significant Fines
•  Cannot ship product
•  No new products approved
•  No export certificates
•  Class action lawsuits
•  Negative Publicity

Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Some Notable Examples
•  Abbott Laboratories
       – $212m
•  LifeScan
       – $60m
•  Guidant
       – $94m
•  Schering-Plough
       – $500m
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Warning Letter Myths
•  The FDA will not issue a warning
   letter to us because …
       – We have a great technology that
         significantly improves quality of life
       – Our customers love us and our
         products
       – We’ve never had a recall
       – We’re too small
       – Patients NEED our product
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Warning Letter Reality
•  The FDA will issue a warning letter if they
   find …
       –  Lack of evidence that top management is
          ACTIVELY involved in the establishment &
          maintenance of the quality system
       –  Significant quality system deficiencies without
          any evidence of bad product or unhappy
          customers
       –  Lack of ability to effectively demonstrate that
          you understand the full weight of the
          regulations and how they specifically apply to
          your products and processes
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Top 5 FDA Compliance Issues

•  Management Responsibility
•  Inadequate Design Controls
•  Inadequate Complaint Handling
•  Inadequate CAPA
•  Inadequate Production & Process
   Controls
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Some Recent Trends
•  From January 2007 to March 2008 one or
   more of the Top 5 violations were cited in
   97% of the Medical Device Warning
   Letters issued for cGMP/QSR related
   problems
•  Over 80% contained at least one
   Management Responsibility violation
•  Of the companies that received
   Management Responsibility violations,
   most were small companies
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Top 5 FDA Compliance Issues

•  Management Responsibility
•  Inadequate Design Controls
•  Inadequate Complaint Handling
•  Inadequate CAPA
•  Inadequate Production & Process
   Controls
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
What is Management
Responsibility?
•  Quality Policy
•  Management with Executive
   Responsibility shall
       – Establish its policy and objectives
         for, and commitment to, quality
       – Ensure that the quality policy is
         understood, implemented, and
         maintained at all levels in the
         organization
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
What is Management
Responsibility?
•  Organization
•  The company must establish and
   maintain an adequate organizational
   structure to ensure that devices are
   designed and produced in accordance
   with the Quality System Regulation
       –  Show responsibility & authority
       –  Provide experienced & trained resources
       –  Management with Executive Responsibility
          must formally appoint a Management
          Representative
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
What is Management
Responsibility?
•  Management Review
•  Management with Executive
   Responsibility shall:
       – Review the suitability and
         effectiveness of the quality system
         at defined intervals with sufficient
         frequency to ensure that the quality
         system satisfies the regulations, the
         quality policy, and quality objectives
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
What is Management
Responsibility?
•  Quality Planning
•  The company must establish a
   quality plan that:
       – Defines the quality practices,
         resources, & activities relevant for
         the devices
       – Establishes how the requirements
         for quality will be met

Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
What is Management
Responsibility?
•  Quality System Procedures
•  The company must establish:
       – Quality system procedures
       – Work Instructions
       – An outline of the documentation
         structure used in the quality system



Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
How does the FDA enforce
Management Responsibility?

  •  A typical FDA investigation will
     begin and end with a review and
     discussion of Management
     Responsibility




Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
How does the FDA enforce
Management Responsibility?
•  Interviews with top management & the
   Management Representative
•  Review of quality policy and quality objectives
•  Review of organizational charts
•  Review of Quality Manual
•  Looks for formally designated Management
   Representative
•  Reviews education, experience, & background of
   Management Representative & other personnel
   performing quality activities

Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
How does the FDA enforce
Management Responsibility?
•  Review of the Quality Plan
•  Asks employees what the quality policy for the
   company is and how their job supports it
•  Reviews the documentation structure for the
   quality system
•  Reviews the procedures for Management
   Review and Quality Audits
•  Reviews additional quality procedures for
   adequacy
•  Reviews work instructions for adequacy &
   alignment with top level quality procedures
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
How does the FDA enforce
Management Responsibility?
•  At the end of the inspection, the
   investigator will make the following
   determination:
•  Has Management with Executive
   Responsibility assured that an
   adequate and effective quality
   system has been fully implemented
   and maintained at all levels of the
   organization?
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
What happens next?

•  If the answer is No, most of the time
   a Warning Letter will be issued at
   some point after the inspection




Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL March 23, 2007
•  Sigma International General Medical Apparatus,
   LLC
•  Failure to provide adequate resources, including
   the assignment of trained personnel, for
   performing management, performance of work,
   and assessment activities, including internal
   quality audits, as required by 21 CFR 820 .20(b)
   (2)
•  Failure of management with executive
   responsibility to ensure that the established
   quality policy is understood, implemented, and
   maintained at all levels of the organization, as
   required by 21 CFR 820.20(a)
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL April 18, 2007
•  TMED, Inc.
•  Failure to adequately establish
   procedures for quality audits and conduct
   such audits to assure the quality system
   is in compliance with the established
   quality system requirements and to
   determine the effectiveness of the quality
   system, as required by 21 CFR 820.22

Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Aug 23, 2007
•  Potty MD, LLC
       –  bedwetting alarm system for children
•  You failed to implement quality system
   procedures [21 CFR 820.20(e)] prior to the
   preannouncement of the inspection on June 11,
   2007. No devices should have been
   manufactured or distributed without a quality
   system in place
•  You failed to appoint a management
   representative to ensure quality system
   requirements are met, and to report to
   management the performance of the quality
   system [21 CFR 820.20(b)(3)]
Melita Ball                    Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant     Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Sept 7, 2007
•  North Coast Medical Inc.
•  Failure to assure that management with
   executive responsibility reviews the suitability
   and effectiveness of the quality system at
   defined intervals and with sufficient
   frequency according to established
   procedures to ensure that the quality system
   satisfies the requirements of this part and the
   manufacturer’s established quality policy and
   objectives as required by 21 C.F.R. 820.20(e)


Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Sept 24, 2007
•  Chiu Technical Corporation
•  Failure to establish and maintain the Quality
   System procedures and instructions, as required
   by 21 CFR 820.20(e)
•  Failure to establish and maintain procedures for
   management review, as required by 21 CFR
   820.20(c). For example, your firm has not
   established and maintained procedures for
   management review to ensure that the quality
   system is maintained

Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Sept. 24, 2007
•  SCM True Air Technologies, LLC
•  Failure of management with executive
   responsibility to assure that an adequate
   and effective quality system has been
   fully implemented and maintained at all
   levels of the organization [21CFR 820.20]



Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Oct 5, 2007
•  EM Probe Inc.
•  Failure to establish a quality plan which
   defines the quality practices, resources, and
   activities relevant to the device, as required
   by 21 CFR 820 .20(d)
•  Failure to establish policy and objectives for,
   and commitment to quality by management
   with executive responsibility, as required by
   21 CFR 820 .20(a)
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Oct 2, 2007
•  Dialysis Dimensions, Inc.
•  Failure to have management with
   executive responsibility ensure that the
   quality policy has been fully implemented
   and maintained [21 CFR 820 .20(a)]



Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Oct 18, 2007
•  Unipower Corporation
•  Failure of management with executive
   responsibility to ensure that an adequate
   and effective quality system has been
   fully implemented and maintained at all
   levels of the organization as required by
   21 CFR 820.20
•  Failure to establish procedures for
   conducting quality audits as required by
   21 CFR 820.22
Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Nov 16, 2007
•  Custom Assemblies, Inc.
•  Failure of management with executive
   responsibility to ensure that an adequate
   and effective quality system has been
   fully implemented and maintained at all
   levels of the organization, as required by
   21 CFR 820.20


Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Nov 16, 2007
•  Danmar Products, Inc.
•  Management with executive responsibility
   has failed to ensure that an adequate
   quality system, has been fully
   implemented and maintained at all levels
   of your organization, as required by
   21CFR § 820.20

Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Recent Warning Letters
•  WL Jan 18, 2008
•  Omron Healthcare, Inc.
•  Failure of management with executive
   responsibility to appoint and document such
   appointment of, a member of management
   who, irrespective of other responsibilities,
   shall have established authority over and
   responsibility for ensuring that quality system
   requirements are effectively established, as
   required by 21 CFR 820.20(b)(3)

Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com
Summary & Final Thoughts
•  My topic today was compliance so we learned
   about all the bad things that can happen when
   companies are not compliant with the regulations
•  My final message, however, is:
     Don’t make all your decisions based on
     compliance alone or you will most likely end up
     with a Warning Letter anyway (or worse)
•  And remember … regulations are here today
   because someone died yesterday without them
•  Make the effort to find the real reason compliance
   IS good business

Melita Ball                  Tel: 520.665.9081   Email: mball@mbcaconsulting.com
Owner/Principal Consultant   Fax: 480.247.5169   Website: www.mbcaconsulting.com