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Development & Deployment of a Development & Deployment of a Risk Based Compliance Risk Based Compliance
Turnaround StrategyTurnaround Strategy
John R. Pinion IIJohn R. Pinion IIGenentech, Inc.Genentech, Inc.
Development & Deployment of a Development & Deployment of a Risk Based Compliance Risk Based Compliance
Turnaround StrategyTurnaround Strategy
John R. Pinion IIJohn R. Pinion IIGenentech, Inc.Genentech, Inc.
The FDA Regulatory and Compliance The FDA Regulatory and Compliance SymposiumSymposium
August 24 – 26, 2005August 24 – 26, 2005
The FDA Regulatory & Compliance Symposium Page 2
Development & Deployment of a Risk Based Compliance Turnaround Strategy
AgendaAgenda1. Objectives2. Keys to Success3. Risk Triggers4. Getting Started / Expectations5. Business Assessment6. Risk Assessment7. Risk Control / Mitigation8. Communication and Timing9. Execution10. Measurement / Effectiveness Review11. Questions
The FDA Regulatory & Compliance Symposium Page 3
Development & Deployment of a Risk Based Compliance Turnaround Strategy
ObjectivesObjectives• Reduce Overall Patient Risk• Reduce Compliance Risk• Improve Overall Business Performance• Focus Resources• Improve Customer Satisfaction• Improve Operating Mechanisms & Management
Visibility• Reset Performance Expectations
The FDA Regulatory & Compliance Symposium Page 4
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Keys to SuccessKeys to Success1. Senior Management Recognition/Understanding of Issues2. Comprehensive Evaluation / Assessment of Business3. Effective Analysis of the Results of the Business Evaluation
(risk / gaps)4. Review of Organization and Talent5. Development of a Risk Analysis / Risk Management6. Creation of a Progress Measurement Approach7. Senior Management Acceptance of Approach8. Broad Communication of Need for Change and Action Plan9. Adequate Resources to Execute Strategy10. Implementation of Routine Senior Management Review Process11. Effectiveness Review of Mitigation Actions
The FDA Regulatory & Compliance Symposium Page 5
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Risk TriggersRisk Triggers• Change in CEO & Other Senior Management
Changes• Restructuring / Mergers• Products
– New Area– New Molecular Entity
• RIF – Process Support Staff
• Regulatory Agency Quality Indicators– FCAs– Complaint Trends or Product Field Performance– Lack of Procedure Maintenance to Current cGMP's
The FDA Regulatory & Compliance Symposium Page 6
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Getting Started / ExpectationsGetting Started / Expectations• Define
– Inputs to Be Included in the Business Assessment– Risk Analysis / Management Model (ISO 14971)– Cross Functional Risk Management Team– Outputs of Process
• Develop and Deploy Measurement System• Identify
– Risks– Mitigation Actions
• Verify Effectiveness of Mitigations• Establish / Initiate Communication with Appropriate Agencies
The FDA Regulatory & Compliance Symposium Page 7
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Getting Started / ExpectationsGetting Started / Expectations
• Product Performance– FCAs– CAPAs– Complaints– Process Performance
• Quality Systems– 8 Key Systems
• Business Processes• Facility Design / Performance• Infrastructure• Talent / Organization• Culture• Resources
– Personnel– Capital
• Product Performance– FCAs– CAPAs– Complaints– Process Performance
• Quality Systems– 8 Key Systems
• Business Processes• Facility Design / Performance• Infrastructure• Talent / Organization• Culture• Resources
– Personnel– Capital
• Product Decisions• Process Improvement Review• Quality System Performance• Business Process
Performance• Facility / Capital Decisions• Organization / Talent Review
Results / Decisions• Legacy Issue CA/PA• Operating Mechanism
Decisions• Progress (Score Card)
Measurement• Results of Effectiveness
Review
• Product Decisions• Process Improvement Review• Quality System Performance• Business Process
Performance• Facility / Capital Decisions• Organization / Talent Review
Results / Decisions• Legacy Issue CA/PA• Operating Mechanism
Decisions• Progress (Score Card)
Measurement• Results of Effectiveness
Review
InputsInputs OutputsOutputs
Input Process Output Model (Example) Input Process Output Model (Example)
Risk Analysis Process
Risk Analysis Process
The FDA Regulatory & Compliance Symposium Page 8
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Getting Started/ ExpectationsOverview – Risk ManagementProcess
Getting Started/ ExpectationsOverview – Risk ManagementProcess
The FDA Regulatory & Compliance Symposium Page 9
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Getting Started / ExpectationsResource CommitmentGetting Started / ExpectationsResource Commitment
Time
Res
ou
rce
Co
mm
ittm
ent
Time
Res
ou
rce
Co
mm
ittm
ent
Long Term EfficiencyGain Following Implementation of Mitigations
Resources Required Short Term to Execute Mitigations
The FDA Regulatory & Compliance Symposium Page 10
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Business AssessmentElements to ConsiderBusiness AssessmentElements to Consider
• Compliance History / Regulatory Commitments• License Status• Product Performance• Facility Condition / Performance (Manufacturing)• Business Infrastructure• Quality Systems• Capital / Resource Commitment• Leadership / Management Responsibility• Organization Structure• Talent• Internal Improvement Processes• Documentation Status
The FDA Regulatory & Compliance Symposium Page 11
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Risk AssessmentRisk Assessment Matrix (example)Risk AssessmentRisk Assessment Matrix (example)
Product, Process,
System, etc.
Gap Identified
Impact
of Gap
Impact On
Severity of Impact
Probability of
Occurrence
Overall Risk
Mitigation or Decision
Mitigation Verification
Overall Risk Post
Mitigation
Define Rating / Scoring Criteria to Help Prioritize Mitigation Actions
Define Rating / Scoring Criteria to Help Prioritize Mitigation Actions
The FDA Regulatory & Compliance Symposium Page 12
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Risk Control / MitigationsDecisions / Actions to be ConsideredRisk Control / MitigationsDecisions / Actions to be Considered
• System Redesign• Management Changes• Organization Changes• FCAs• Process Improvements• Facility Capital Improvements• Retirement of Product• Facility Closure /
Simplification
• Validation• Improved Documentation• Improved Operating
Mechanisms• Employee Education• CAPA• Labeling Enhancements • Product Improvements• Regulatory Submission
Updates
The FDA Regulatory & Compliance Symposium Page 13
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Communication / TimingCommunication / Timing
Audience Frequency Objective
Senior Management MonthlyReview / Discuss Overall Level of Risk, Key Decisions
Risk Management Team WeeklyProcess / Progress / Issue Review
Quality Organization WeeklyProcess / Progress / Issue Review
Broad Organization Monthly Awareness
Regulatory AgenciesEstablish in Conjunction
With AgencyUpdate on Progress, Gain Feedback
Customers / PatientsAs Necessary Based on
DecisionsEnsure Patient Safety
Business StakeholdersAs Necessary
(Material Decisions)Meet Fiscal Requirements
The FDA Regulatory & Compliance Symposium Page 14
Development & Deployment of a Risk Based Compliance Turnaround Strategy
Communication / TimingCommunication / Timing
Time (days - example)Time (days - example)
Def
ine
Inpu
ts to
Be
Incl
uded
As
a P
art o
f the
Bus
ines
s A
sses
smen
tC
ondu
ct /
Com
plet
e In
itial
Bus
ines
s A
sses
smen
tD
evel
op M
easu
rem
ent
Sys
tem
Com
plet
e R
isk
Ana
lysi
sP
riorit
ize
Miti
gatio
n
Act
ions
Impl
emen
t Act
ions
Ver
ify E
ffect
iven
ess
Rea
sses
smen
t
Start 30 90 180 730 (Dependant of Gaps and Mitigations Needed)
CommunicationCommunication
Development & Deployment of a Risk Based Compliance Turnaround Strategy
The FDA Regulatory & Compliance Symposium Page 15
Development & Deployment of a Risk Based Compliance Turnaround Strategy
ExecutionKey ConsiderationsExecutionKey Considerations
• Well Developed Plan• Communication / Alignment of Organization• Objective / Fact Based Measurement• Employee Training & Development• Prioritization• Visible Management Commitment• Dedicated Resources• Third Party Review of Approach / Progress• Forecast of Activity• Commitment to Make the Difficult Decisions• Verification of Effectiveness
The FDA Regulatory & Compliance Symposium Page 16
Development & Deployment of a Risk Based Compliance Turnaround Strategy
MeasurementMeasurement
Measurement Approach Objective
Risk Reduction Tracking Risk Analysis Document Verify Reduction of Risk
Mitigation Action Progress Tracking
Score CardEnsure Timely Implementation of Mitigation Actions
Product / Process Trend Data Management ReviewConfirm Effectiveness of Mitigation Actions
Internal Assessment Trends Management ReviewConfirm Effectiveness of Mitigation Actions
Third Party Assessment Results
AD Hoc ReviewConfirm Effectiveness of Mitigation Actions
The FDA Regulatory & Compliance Symposium Page 17
Development & Deployment of a Risk Based Compliance Turnaround Strategy
MeasurementMitigation Action Score CardMeasurementMitigation Action Score Card
Mitigation Person Responsible
Initial StatusCurrent Status
Verification of Effectiveness
Forecast
Mitigation 1
Action 1
Action 2
Action 3
Mitigation 2
Action 1
Action 2
Action 3
The FDA Regulatory & Compliance Symposium Page 18
Development & Deployment of a Risk Based Compliance Turnaround Strategy
• Business AssessmentBusiness Assessment• Risk AnalysisRisk Analysis• Mitigation PlanMitigation Plan• Effectiveness ReviewEffectiveness Review
• Business DecisionsBusiness Decisions• Measurement Feedback Measurement Feedback • 33rdrd Party Feedback Party Feedback• Prioritization Prioritization • Compliance EventsCompliance Events
• Risk Management TeamRisk Management Team• Dedicated ResourcesDedicated Resources• CommunicationCommunication• Execution and ReviewExecution and Review
• Risk Reduction TrackingRisk Reduction Tracking• Mitigation Score CardMitigation Score Card• Management Review (Trend Data)Management Review (Trend Data)• Assessment TrendsAssessment Trends• Third Party Assessment ReviewThird Party Assessment Review
StrategyStrategy
DeploymentDeployment
MeasurementMeasurement
AdjustmentAdjustment
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Questions??Questions??