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Intro to Data Integrity
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Integrity/Governance - Dublin
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Peter Baker 4/8/26 Peter Baker 4/8/26

Risk Approximation

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Peter Baker 4/8/26 Peter Baker 4/8/26

“all sources of variability”

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Peter Baker 4/8/26 Peter Baker 4/8/26

Draft Guidance 211.110 (Process Validation & Control)

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Peter Baker 4/8/26 Peter Baker 4/8/26

Doc Control: when is enough, enough?

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Peter Baker 4/8/26 Peter Baker 4/8/26

Original Records

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Peter Baker 4/8/26 Peter Baker 4/8/26

Thoughts on RCA

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Peter Baker 4/8/26 Peter Baker 4/8/26

“Reliability”

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Peter Baker 4/8/26 Peter Baker 4/8/26

“It is what it is”

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Peter Baker 4/8/26 Peter Baker 4/8/26

“Level of Risk”

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Peter Baker 4/8/26 Peter Baker 4/8/26

Supplement the Swag

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Peter Baker 4/8/26 Peter Baker 4/8/26

“One Wing and a Prayer”

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Peter Baker 4/8/26 Peter Baker 4/8/26

Compliance?

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Peter Baker 4/8/26 Peter Baker 4/8/26

A Quality Framework: AI/ML

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Peter Baker 4/8/26 Peter Baker 4/8/26

Validation

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Peter Baker 4/8/26 Peter Baker 4/8/26

Knowledge Management

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Peter Baker 4/8/26 Peter Baker 4/8/26

QMM Updates

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Peter Baker 4/8/26 Peter Baker 4/8/26

15 Years!

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Peter Baker 4/8/26 Peter Baker 4/8/26

Objective 4

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Peter Baker 4/8/26 Peter Baker 4/8/26

Formality

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Peter Baker 4/8/26 Peter Baker 4/8/26

Artificial Assistance

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