february 23 24, 2015 cape canaveral, fl · february 23–24, 2015 • cape canaveral, fl mhra warns...
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![Page 1: February 23 24, 2015 Cape Canaveral, FL · February 23–24, 2015 • Cape Canaveral, FL MHRA Warns Diabetics About Counterfeit Insulin Pen Needles Counterfeit batch of insulin pen](https://reader035.vdocument.in/reader035/viewer/2022071301/60a1ed439955993ed6549043/html5/thumbnails/1.jpg)
22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
Manufacturing in the
Healthcare Industry:
Quality Challenges
and Tools
Gerard J. Pearce Executive Vice President
SQA Services, Inc.
22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
Forces impacting
Quality in healthcare
manufacturing
New Technology
Internal Change
External Threat
Tools and Techniques
for Quality
Adaptation
Prioritization
Optimization
TODAY
Objective Focus
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
HEALTHCARE QUALITY PLAYING FIELD
• Highly regulated, and focused on patient safety
• Conservative, risk-averse
• Relatively long development cycle
• Innovation emphasis on R&D
N Engl J Med 2013; 368:2043-2045
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
ANTICIPATING
QUALITY
NEEDS
• FDA working to respond
to, anticipate, and help drive
scientific developments
• FDA defining and clarifying
regulatory pathways and
policies
• Establishing a basis for
Quality professionals to
anticipate and prepare for
the changes to come with
new technologies
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
HEALTHCARE QUALITY INFLUENCERS
Parenteral Drug Association
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
QUALITY FOCUS
• Best patient and business outcome
• Regulatory, in conjunction with FDA goal that
“products consistently meet applicable
requirements and specifications”
• Environmental (Internal)
• Environmental (External) Regulatory
External Internal
Quality
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
Finished Product Raw Materials
API
Excipient
Packaging
Distribution Delivery Use
GMP GIP GDP
GPP Pharmacovigilance
QUALITY IN THE PRODUCT CHAIN
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
REGULATORY INITIATIVES
• FDA Safety and Innovation Act 2012 (risk
management, global focus, enhanced tools)
• FDA Drug Quality and Security Act 2013
(Track and Trace)
• EMA Falsified Medicines Directive 2013
(authenticity, controls, documentation)
• FDA Unique Device Identification Guidance
2014 (safety, surveillance)
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
COMMERCIAL CHANGES
• Actavis – Allergan
• Pfizer – Wyeth
• Glaxo Wellcome – SmithKline Beecham
• Teva – Barr
• Merck – Schering-Plough
• Abbott – Solvay
• etc.
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
SAFE SUPPLY
FOCUS
• Extended supply
chains
• Growth in
outsourcing
• Decentralized
controls
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
COST OF POOR QUALITY
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
QUALITY FAKES
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
MHRA Warns Diabetics About
Counterfeit Insulin Pen Needles Counterfeit batch of insulin pen needles found
circulating in UK supply system The Medicines and Healthcare products Regulatory
Agency (MHRA) is today warning diabetics about a
counterfeit batch of insulin pen needles that are
circulating in the UK.
14
May 7, 2007
80 children die in Haiti due to contaminated
glycerin in acetaminophen syrup
COST OF POOR QUALITY
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
QUALITY CONCERNS
• Fast changes, slow industry
• Interpretation of standards
– Client-specific needs
– Controlling quality at contract
manufacturers
• Supply Chain globalization
• Other:
– Security
– Managing ‘end-of-cycle’
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
SUPPLIER EVALUATION
• Supply chain is a moving target
• Distance, language, culture and local
knowledge
• CAR Sickness
• ‘Standard’ Tools and Systems
• Quality-Supply Management disconnect
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
Forces impacting
Quality in healthcare
manufacturing
New Technology
Internal Change
External Threat
Tools and Techniques
for Quality
Adaptation
Prioritization
Optimization
TODAY
Objective Focus
![Page 18: February 23 24, 2015 Cape Canaveral, FL · February 23–24, 2015 • Cape Canaveral, FL MHRA Warns Diabetics About Counterfeit Insulin Pen Needles Counterfeit batch of insulin pen](https://reader035.vdocument.in/reader035/viewer/2022071301/60a1ed439955993ed6549043/html5/thumbnails/18.jpg)
22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
ADAPTING TO CONDITIONS
• Risk-based approach
• Harnessing best practice and technology
• Social Media and Industry Collaboration
• Structure for Success
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
RISK-BASED APPROACH
• Focus based on status and risk
• Strategic Partners
• Strategic Stinkers
• Regional Coverage
low medium high
high
medium
low
Criticality
Fai
lure
s
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
RISK-BASED APPROACH
Spend/Leverage
Criticality Low High
Quality Performance
Environment
Good Poor
Little Much
Stable Unstable
less
fre
quent
more
fre
quent
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
RISK-BASED APPROACH
High-level look to low-level look:
1. ‘D&B-style’ check
2. Self- or desk-audit
3. ISO-style audit
4. Specialized audit
5. Assessment
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
Qualification
& Validation
Lead
ers
hip
Policy and
Strategy for
GMPs
Resources
GMP
Compliance
Personnel
Orientation
Current Auditing
Coverage moving towards broader scope
RISK-BASED APPROACH
Investigation System & Improvement
Ris
k M
anag
em
ent
Pro
cess
es
Contr
ols
and A
ctual
Cap
abili
ty
Busi
ness
Resu
lts
(KPIs
)
Enablers Results
General
System
Inputs
and
Outputs
Elements needed
for full PDCA
Closure
Total Quality Management
Supplier Evaluation Evolution:
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
RISK-BASED APPROACH
Supplier
Impact
Evaluation
Investment
Supplier Impact-Investment Map
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
BEST PRACTICE AND TECHNOLOGY
• Supplier review and rationalization
• Deeper supplier scrutiny
• Quality Agreements
• Common-sense controls
• Tracking and Screening Methods
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
XY RSA
BC Plan.pdf
BEST PRACTICE AND TECHNOLOGY
• ‘Virtual’ replaces ‘Desktop’
• True ‘Remote’ Audits
• Both quantitative and
qualitative
• Results trigger next steps
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
BEST PRACTICE AND TECHNOLOGY
Helping answer two key questions:
• Is the program on track?
• What is the program telling us?
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
BEST PRACTICE AND TECHNOLOGY
Data Analytics aim to create
‘Supply Chain Intelligence’
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
BEST PRACTICE AND TECHNOLOGY
Quality / Performance Are they succeeding?
External
factors - Are they
impacted by the
environment?
Compliance - Are they set up to
succeed?
Criticality
- how important are they?
Overall Risk
Supplier Scorecard
Supplier Dashboard
Supplier Quality Profile
…others?
Integrating supply chain data:
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
SOCIAL MEDIA & INDUSTRY COLLABORATION
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
STRUCTURE FOR SUCCESS
Balance between:
Inspections
Non-conforming product
Supplier Corrective Action
Material returns
Quality Agreements
Supplier Scorecards
Supplier Consolidation
Supplier Qualification
Supplier Audits & Assessments
Supplier Remediation
Quality
Control and Quality
Development
![Page 31: February 23 24, 2015 Cape Canaveral, FL · February 23–24, 2015 • Cape Canaveral, FL MHRA Warns Diabetics About Counterfeit Insulin Pen Needles Counterfeit batch of insulin pen](https://reader035.vdocument.in/reader035/viewer/2022071301/60a1ed439955993ed6549043/html5/thumbnails/31.jpg)
22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
Finished Product Raw Materials
API
Excipient
Packaging
Distribution Delivery Use
GMP GIP GDP
GPP Pharmacovigilance
QUALITY IN THE PRODUCT CHAIN
![Page 32: February 23 24, 2015 Cape Canaveral, FL · February 23–24, 2015 • Cape Canaveral, FL MHRA Warns Diabetics About Counterfeit Insulin Pen Needles Counterfeit batch of insulin pen](https://reader035.vdocument.in/reader035/viewer/2022071301/60a1ed439955993ed6549043/html5/thumbnails/32.jpg)
22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
TODAY
Forces impacting
Quality in healthcare
manufacturing
New Technology
Internal Change
External Threat
Tools and Techniques
for Quality
Adaptation
Prioritization
Optimization
Objective Focus
![Page 33: February 23 24, 2015 Cape Canaveral, FL · February 23–24, 2015 • Cape Canaveral, FL MHRA Warns Diabetics About Counterfeit Insulin Pen Needles Counterfeit batch of insulin pen](https://reader035.vdocument.in/reader035/viewer/2022071301/60a1ed439955993ed6549043/html5/thumbnails/33.jpg)
22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
RECOMMENDED READING
• Dangerous Doses – Katherine Eban
• The Signal and the Noise – Nate Silver
• Single Point of Failure – Gary Lynch
• Reinventing Discovery – Michael Nielsen
• Phake – Roger Bate
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
Questions and further information:
Gerard Pearce
310-802-4448
THANK YOU!
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22nd Annual Conference on Quality in the Space and Defense Industries
February 23–24, 2015 • Cape Canaveral, FL
GBP • Complex environment
• Detailed requirements
• Simple trigger
• Action