Development & Deployment of a Risk Based Compliance Turnaround Strategy John R. Pinion II Genentech, Inc. The FDA Regulatory and Compliance Symposium August.

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



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



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



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



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



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




Getting Started/ ExpectationsOverview – Risk ManagementProcess

Getting Started/ ExpectationsOverview – Risk ManagementProcess



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



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



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



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



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



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




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



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



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



• 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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i m a g i n a t i o ni m a g i n a t i o ni m a g i n a t i o ni m a g i n a t i o ni m a g i n a t i o ni m a g i n a t i o n

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c r e a t i v e n e s sc r e a t i v e n e s sc r e a t i v e n e s sc r e a t i v e n e s sc r e a t i v e n e s sc r e a t i v e n e s s

p r e s e n t a t i o n sp r e s e n t a t i o n sp r e s e n t a t i o n sp r e s e n t a t i o n sp r e s e n t a t i o n sp r e s e n t a t i o n s

Questions??Questions??

Development & Deployment of a Risk Based Compliance Turnaround Strategy John R. Pinion II Genentech, Inc. The FDA Regulatory and Compliance Symposium August.

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