Seminar – Teal 0226

The Leader in Quality Life Science Training

TALKFDA SIGNATURE SEMINARS

AI in Drug Discovery

Aligning with FDA’s Latest Risk-Based Framework

Capability indices like Cp and Cpk can influence validation, release, and quality decisions — but only when the underlying data assumptions are correctly evaluated. This session focuses on structuring those statistical decisions with clarity, so capability results genuinely reflect process performance and support confident operational conclusions.

Designed for professionals working with process capability, validation, or quality decisions shaped by statistical data.

How This Session Is Structured

This session brings structured clarity to selecting appropriate capability indices for attribute and variable data, verifying distribution assumptions before calculation, and applying transformations only when statistically justified. It focuses on aligning statistical methods with manufacturing and regulatory expectations so capability results support sound validation and quality decisions.

DAY 1: Blah Blah Blah Blah Blah Blah Blah

Build the regulatory mindset behind inspection outcomes. Build the regulatory mindset behind inspection outcomes.

Regulatory requirements influencing capability and reliability evaluations
Theory and terminology behind capability indices
Application of Cp, Cpk, and related measures
Attribute versus variable data selection decisions
Evaluating data for normality before index calculation
Transforming data appropriately when assumptions are not met

DAY 2: Blah Blah Blah Blah Blah Blah Blah

Build the regulatory mindset behind inspection outcomes. Build the regulatory mindset behind inspection outcomes.

Regulatory requirements influencing capability and reliability evaluations
Theory and terminology behind capability indices
Application of Cp, Cpk, and related measures
Attribute versus variable data selection decisions
Evaluating data for normality before index calculation
Transforming data appropriately when assumptions are not met

Course Led By

John E. Lincoln

John E. Lincoln brings over four decades of hands-on experience across FDA-regulated industries, advising organizations on inspections, QMS remediation, and global regulatory alignment. Known for translating regulatory shifts into practical inspection strategy, he helps teams prepare for FDA expectations as they actually unfold—not as theory.

What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

A confirmation email outlines onboarding details and next steps
Access credentials are shared in advance so you are prepared before the session
Handouts (where applicable) are provided ahead of time
The training is delivered live via Webex with interactive participation and Q&A
Certificates of completion are issued following the session
For live + recording access, post-session availability is provided through TalkFDA
Event support remains available for any access or logistics assistance

Access is provided in a structured and professionally supported format.

A confirmation email outlines onboarding and next steps
The complete session recording is delivered through TalkFDA
Access is granted shortly after purchase so you can begin without delay
Recording includes the full presentation and instructor-led discussion
Certificates of completion are issued upon course completion
Support remains available for any technical or access assistance

For Teams Seeking Deeper Implementation Support

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

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MD1983

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