management responsibility for fda quality systems
TRANSCRIPT
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Quality Systems Thinking – Management’s Responsibilities
Denise D. Dion,
Vice President Regulatory and Quality Services
EduQuest, Inc.
EduQuest Education: Quality Engineering, Science, & Technology
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EduQuestEDUcation: QUality Engineering, Science and Technology
• Global team of FDA compliance experts based near Washington, DC
• Founded by former senior officials & investigators from FDA’s Office of Regulatory Affairs (ORA) Headquarters
• Advising medical device and bio-pharmaceutical companies worldwide since 1995
• Focus on Audits and Training for Quality Systems, Risk Management, Part 11, Validation, Inspection Readiness
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Denise DionVice President,
Regulatory & Quality ServicesEduQuest
• 18 years of experience with the U.S. FDA Office of Regulatory Affairs (ORA)
• Former FDA Medical Device Expert Investigator
• Developed many of FDA’s inspection guidance and training materials
• Primary editor of the FDA Investigations Operations Manual (IOM) – the “bible” for FDA inspectors
• Lead instructor for EduQuest CAPA, QSR Basics, and Design Control classroom training courses (www.EduQuest.net)
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Basic Quality System Concepts
“Quality has to be caused, not controlled.”
From “Philip Crosby's Reflections on Quality”
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Purposes of a Quality System
• To provide a defined operational framework
– Including appropriate and clearly documented
processes and procedures
• To assure that quality is designed and built in
• To provide documented, objective evidence of what
was done during design/development and manufacture
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“Quality” and “Compliance”
• Quality and compliance are not the same
– Quality done right will result in compliance
– Compliance, on the other hand, will not necessarily
create or ensure the quality of processes or products
• Your organization must have both to succeed
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“Quality” and “Compliance”
• The quality of a product is governed by the quality
of the processes used in its design and manufacture
– If you have poor processes and procedures,
complying with your quality system will just
ensure that you consistently have poor quality
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Underlying Principles
• The quality system must be defined, documented,
implemented, and consistently followed to be
effective and compliant
• Constant self-critical and self-correcting loop
– Process and product knowledge, measurement,
control, and continuous improvement
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Underlying Principles
• A compliant quality system starts and ends with
management (or it simply doesn’t exist)
– Management will be held legally responsible for
the effectiveness or non-effectiveness of the
quality system
– Every quality system failure can and will be tied
back to management
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Underlying Principles
• Companies must implement “global” corrective and
preventive actions
– Similar changes should be made across all FDA-
regulated sites and operations
• Consistent with a systems-based approach
• Inconsistent with common industry practices
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Why Focus on Responsibility?
• An inherent concept of all FDA regulation
• Establishes the context for understanding
• Provide a realistic view of
– The consequences of non-compliance
– Actions being taken by FDA
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US Regulatory Framework
• The US law –
– Federal Food, Drug, and Cosmetic Act
– Very different from other countries’ regulatory laws
– “Strict liability” criminal law
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Strict Liability
• The FD&C Act is not like most other criminal laws
• The FD&C Act is a “strict liability” statute.– Management may be individually found
responsible for a violation of the FD&C Act – even though you did not participate in the violation, were not aware of the violation, and/or did not act with criminal intent – or even negligence.
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Strict Liability – Supreme Court Cases
• United States v. Dotterweich– “[This type of] legislation dispenses with the
conventional requirement for criminal conduct – awareness of some wrongdoing. In the interest of the larger good it puts the burden of acting at hazard upon a person otherwise innocent but standing in a responsible relationship to a public danger.”
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Strict Liability – Supreme Court Cases
• United States v. Park– “Thus Dotterweich and the cases which have followed
[hold that] the [Food and Drugs] Act imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will ensure that violations will not occur.”
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Strict Liability – Supreme Court Cases
• United States v. Park– The court held that it’s not enough to correct– Management must make sure they prevent
reoccurrence or prevent occurrence in the first place!
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US Regulatory Framework
• FDA has enforcement responsibility and powers
– Not just a gatekeeper for the US market
– FDA acts as a law enforcement agency
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Federal Food, Drug, and Cosmetic Act
• Prohibited Acts
– The refusal to permit access to or the copying of records
– Causing the introduction into interstate commerce of an adulterated product
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Federal Food, Drug, and Cosmetic Act
• Prohibited Acts
– The refusal to permit inspection
– The manufacture of any adulterated or misbranded food, drug, device, or cosmetic
Note: The FD&C Act states that products are adulterated if they are not made in compliance with cGMP
regulations!
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Federal Food, Drug, and Cosmetic Act
• Regulation examples
– GMPs (Quality System Regulation for
Devices)
– GLPs
– BioResearch monitoring
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FDA Regulations
• Regulations are . . .
– Quality standards
– Combination of subjective and objective requirements
– Umbrella regulations
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FDA’s QSR Requirements
• The QSR regulations establish mandatory, minimum
requirements
– Compliance is not an option or a matter of choice
– Complying with QSR is the lowest acceptable
quality standard
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Management Responsibility
• The cornerstone of quality systems and FDA’s approach
– Management cannot delegate its responsibility or just
designate someone else to be on the hook
– The old ways of corporate management (“that’s
Quality’s job”) are not going to work anymore
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Management Responsibility
• Remember – this is a strict liability law
– Ignorance has never been a valid excuse
• Going forward, ignorance and/or a lack of direct
involvement will absolutely guarantee failure
– No matter how good your Quality organization is
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Management’s Responsibilities
• Management must implement a quality system
that includes – A quality policy
– Quality objectives
– Quality plan and quality system procedures
– Identification of a management representative
– Adequate organizational structure and resources
– Appropriate responsibilities and authorities25
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Management Reviews
• Management reviews must be conducted to review the suitability and effectiveness of the quality system at defined intervals of sufficient frequency
– Written procedures and schedule
– Documented dates and results
• Focus on the health of the Quality System
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Management Reviews
• Not just how many CAPAs, or complaints or how many are late, or how many recalls or MDRs
• Why are we having problems?
– Root Cause
– What part of the Quality System isn’t working and why?
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Resources
• Money – to fund improvements, hire staff
• Time – to do it right
• People – knowledge, training, experience, sufficient number
• Facilities – space, cleanliness
• Equipment – the correct equipment, maintained, calibrated
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Quality Audits
• Quality audits to assure the quality system is in compliance with established QS requirements and to determine effectiveness
– Conducted by independent individual(s)
– Corrective actions of deficiencies
– Re-audits of deficient matters
– Reports made and reviewed by management responsible for the areas audited
– Dates and results documented
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Training
• Defined by Job Description
– Education
– Background
– Experience
• Defined in Training Matrix
– To procedures and processes and policies
– To the regulation, standards
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Training
• Background, education and experience
– Resume, CV – Diplomas, course certificates
– Certifications or licenses
• Training
– Certificates
– In-house, 3rd party, etc.
• Training Folder
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Critical Awareness and Acceptance
• Management will need to demonstrate that the company
really “gets it” and is serious about its commitments
– Needs to be done through actions and not just words
– Cannot demonstrate it to FDA without clearly and
consistently demonstrating it internally
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Common Traps and Failures
• The management “reality gap”– failure to recognize
significant gaps between senior management
perception of compliance issues and the reality of
the operations on the ground
– Often coincides with a corporate culture that does
not support or encourage the reporting of negative
information up through the chain of command
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Common Traps and Failures
• The “no observation – no problem” rationale
– Management is not willing to correct a problem
until and unless FDA cites it in a 483 observation
– Sends a clear message that defects and poor quality
are acceptable as long as FDA doesn’t detect them
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Common Traps and Failures
• A company’s view of “risk” should never include
what is commonly called “regulatory risk”
– The risk of detection of a problem by FDA
– The potential consequences of being “caught”
• FDA expects risk analyses to be documented, so
those documents are in-scope during inspections
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Inspection and Enforcement Process
• FDA inspections can occur for several reasons
– Routine GMP inspection (usually every 2-3 years)
– Routine Bioresearch Monitoring (GLP/GCP) inspection
– Pre-approval request (e.g., for a new product or process change)
– FDA concern (e.g., after a complaint or recall)
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Inspection and Enforcement Process
• FDA has regulatory authority over a broad range of products and industries including foods, drugs (human and animal), medical devices, biologic products, radiation emitting products, etc.
• Each set of regulations for these products and industries include provisions for responsibility and accountability.
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Inspection and Enforcement Process
• Understanding the FDA mindset
– Require objective evidence
– Not primarily focused on intent
– “If it isn’t documented, it didn’t happen”
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Consequences of Non-Compliance
• Possible regulatory enforcement actions
– Disqualification of a nonclinical laboratory
– Clinical hold or termination
– Delay in approval of new products or facilities
– Rejection of application data (e.g., clinical trials)
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Consequences of Non-Compliance
• Possible regulatory enforcement actions
– Disqualification of clinical investigators
– Initiation of the Application Integrity Policy
– Warning Letter (including sanctions)
– Product seizure
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Consequences of Non-Compliance
• Possible regulatory enforcement actions
– Import restrictions
– Consent Decree
– Criminal prosecution
– Debarment
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Consequences of Non-Compliance
• Other (non-regulatory) consequences
– Can be very significant
• Media coverage
• Competitors’ responses
• Litigation risks and costs
• Financial market reactions
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What is a Consent Decree?
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Recent Enforcement Developments
• Consent Decrees
– Schering Plough $500,000,000 +
– Abbott Laboratories $100,000,000 +
– Wyeth-Ayerst $30,000,000 +
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Recent Enforcement Developments
• Criminal Plea Agreements
– Johnson & Johnson $60,000,000
– Roussel Uclaf $33,000,000
– Endovascular Technologies $92,400,000
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Recent Consent Decrees
• Initial “fines” of 30 to 500 million dollars
• Ongoing forfeiting (“disgorgement”) of profits
• Additional penalties for missing deadlines
• Very heavy FDA involvement and review
• Corporate executives signed as individual defendants
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FDA Press Release
• “Manufacturers who choose to wait until FDA
investigators find violations rather than policing
themselves will find that they have made a poor and
costly mistake.”
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Developing Trends
• FDA expects companies to implement “global” corrective actions
– Similar corrective changes should be made across all FDA-regulated sites and operations
– Consistent with a quality system approach
– Inconsistent with common industry practices
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Developing Trends
• The expectations and approach are growing
beyond FDA and the US
– United Kingdom, European Community,
Australia, Germany, Japan, Brazil, China, India
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Recommendations for Success
• Understand the US regulatory framework
– Scope of FDA’s inspectional authority and enforcement powers
– Expectations regarding basic good practices, effective management, and control
– Changing regulatory environment
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Recommendations for Success
• Be realistic and accurate
– Common industry perception that FDA and its approach are “over the top”
– Most inspectional observations focus on very basic compliance issues and operational controls
– Understand your current practices and challenge your assumptions
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Recommendations for Success
• Much less costly to be proactive and protective
– Once detected, it may cost over 100 times more to resolve the problems to FDA’s satisfaction
– In this area, an ounce of prevention is worth much more than a pound of cure
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Recommendations for Success
• Focus first on sound logic and good scientific practices
– This is what the regulators are usually looking for
• Companies fail because they continue to apply poor
practices that cannot be justified or defended
• “Do it right, and compliance will follow”
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Quality System
• The Quality System is the responsibility of everyone. It is not owned by quality assurance!
• Quality must be built into the process• Quality is not tested into the product• Assurance of Quality comes from
– Design of robust products and processes based on thorough knowledge of those products and processes and the sources of variability
– Effective Quality System in place
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Questions or Comments?
Contact: [email protected]; 240-449-5852
EduQuest, Inc.1896 Urbana Pike, Suite 14
Hyattstown, MD 20871+1 (301) [email protected]
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EduQuestEDUcation: QUality Engineering, Science and Technology
Additional Opportunity for Staff Training from EduQuest:
The CAPA Confidence Clinic: Effective CAPA Systems, Failure Investigations & Complaint Management
• September 27-28, 2012 – Frederick, MD (near Baltimore and Washington, DC)
QSR Compliance Basics: Complying with FDA’s Medical Device 21 CFR 820 Quality System Regulation
• October 16-17, 2012 – Frederick, MD (near Baltimore and Washington, DC)
Design Control for Medical Devices: Meeting FDA’s 21 CFR 820.30 Rules for Quality Design and Manufacturing
• October 17-19, 2012 – Frederick, MD (near Baltimore and Washington, DC)
Details at www.EduQuest.net Or Email: [email protected]
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