Skip navigation

Day One | Tuesday, June 20, 2017

12:00

Conference Registration

1:15

Co-Chairs Welcome and Opening Remarks

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis, Inc.

Marzena Ingram
Manager, Continued Process Verification GSO —
Technical Operations Process Validation
Apotex, Inc.

1:30

FDA Quality Metrics, Data Integrity and Application of Statistics Throughout Process Validation in a Global Economy

Jerry Lanese, PhD
President
The Lanese Group, Inc.

2:15

Understand the Process Validation Lifecycle and the Need for “Fit for Purpose” Statistics

I. Stage I Process Design (ICH Q8(R2) Pharmaceutical Development)

II. Stage II Process Performance Qualification (PPQ)

III. Stage III Continued Process Verification (CPV/OPV)

Marzena Ingram
Manager, Continued Process Verification GSO —
Technical Operations Process Validation
Apotex, Inc.

3:00

Networking and Refreshment Break

3:30 – 5:00

CHOOSE FROM TWO 90-MINUTE SESSIONS (1-2)

SESSION 1 Statistics Bootcamp for the Non-Statistician

I. Know the Statistical Basic Concepts

II. Process Stability and Capability

III. Fundamentals of Design of Experiments (DOE)

IV. Acceptance Sampling Overview

V. Enhance the Power of Communication of Statistical Analysis

Mauricio Chinchilla, M.Eng.
Senior Validation Engineer
Abbott Vascular

SESSION 2 Senior-Level Think Tank — Effective Methods for the Advanced Professional

In this closed-door summit, senior-level computer validation and quality managers from pharmaceutical, biotech and medical device companies engage in open discussions with their colleagues about strategies for managing statistics in validation.

The content for the summit is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss. This session is open to the first twenty senior-level professionals who pre-register for the interactive discussion group.

*To pre-register, you must have over 5 years of experience in CSV execution and currently work for a pharmaceutical, medical device or biotech company. IVT reserves the right to qualify participants for this workshop.

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis, Inc.

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

Day Two | Wednesday, June 21, 2017

7:30

EYE-OPENER BREAKFAST DISCUSSION The Right Statistical Tools and Methods — Solutions to Solve Your Problems in Process Validation

“What statistical tools should I use in process validation?” is an often asked question. A more informative approach is to first identify the problem at hand, then select the appropriate statistical tools and methods to solve the problem. The fundamental principle is that the problem identifies the appropriate statistical tools and methods not the other way around. Using this principle, this presentation examines some of the critical problems addressed in the different stages of process validation and then identifies the various statistical tools that can be used to create the solution.

Ronald D. Snee, PhD
President
Snee Associates, LLC

8:15

Co-Chairs Review of Day One

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis, Inc.

Marzena Ingram
Manager, Continued Process Verification GSO —
Technical Operations Process Validation
Apotex, Inc.

8:30

Improper Use of Statistics — Misuses, Misinterpretation and Bias

Douglas B. Brown, PhD
Research Scientist, Methods Development, Biologics Testing Solutions
Charles River Laboratories, Inc.

9:15

Evolving Trends in the Use of Statistics for Process Validation

Katherine Giacoletti, M.Stat
Partner
SynoloStats

10:00

Networking and Refreshment Break

90-MINUTE SESSION

10:30

Using Statistics that Support Quality by Design (QbD)

I. Define the Goals of QbD

II. Design of Experiments

III. Modelling: Build, Test, Refine, Evaluate

IV. Statistical Quality/Process Control

V. Interactive Exercise

Jordan Collins, PhD
Manager, Statistical Support – Global Research and Development
Apotex, Inc.

12:00

Networking Luncheon

90-MINUTE SESSION

1:15

Determination of Sampling Plans Utilizing Risk Analysis

This session focuses on how to determine sampling plans for validation studies, as well as, how to perform comparative studies to ensure multiple processes are equivalent. The method that will be presented will utilize a combined statistical and risk-based approach that varies the statistical confidence based on the risk components of the system or process being qualified. This approach gives a justification for each sampling plan and will give a high assurance that highly capable processes will meet the criteria.

Jeffrey S. Hanson
Certified Quality Engineer from ASQ,
Manager – Technical Services
Upsher-Smith Laboratories, Inc.

2:45

Networking and Refreshment Break

3:15 – 4:45

CHOOSE FROM TWO 90-MINUTE SESSIONS (3-4)

SESSION 3 Biologics — A Case Study in Non-Normal Data

I. Introduction to Simple Stats with Normal Data

II. Discuss Non-Normal Processing Data

III. Learn How to Perform Simple Non-Normal Process Capability Analysis

IV. Interactive Activity

Edward (Ned) Wyman
Principal Scientist, MS&T/ Validation – Biologics
AstraZeneca – Global Operations

SESSION 4 Understand the Benefit and Danger of Statistical Acceptance Criteria for PPQ

I. Statistical Confidence

II. Use of Statistical Intervals as Acceptance Criteria

III. Interactive Activity

Tara Scherder, MS Statistics, BS Chem E
Partner
SynoloStats

5:00

Close of Day Two

Day Three | Thursday, June 22, 2017

8:00

Continental Breakfast

8:30 – 10:00

CHOOSE FROM TWO 90-MINUTE SESSIONS (5-6)

SESSION 5 Data Science and Ensuring Data Integrity

I. Data Integrity, Data Lifecycle and its Impact to Statistics

II. ALCOA: What Does This Mean to Data Integrity, Data Lifecycle and Statistics

III. Data Integrity’s Impact on Data Mining, Business Intelligence, Data Warehousing and Statistics

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis, Inc.

SESSION 6 Using Statistics to Identify and Understand Process Capability and Control — Statistical Process Control and the Use of Control Charts

This session introduces and discusses the concept and need for process capability and continued process verification using statistics as a tool for quality control. The development of a system to monitor and control processes and procedures assists with enhancing product conformity, reducing waste and identifying product drift and potential loss of system control. A primary focus for process control is to ensure that the behavior of validated processes and procedures has not changed and is continuing to perform as previously described.

I. Process Capability Approach and Process Improvements

II. Statistical Process Control (SPC)

III. Control Charting Basics Using Microsoft Excel

Douglas B. Brown, PhD
Research Scientist, Methods Development, Biologics Testing Solutions
Charles River Laboratories, Inc.

10:00

Networking and Refreshment Break

90-MINUTE SESSION

10:30

Continued Process Verification (CPV) — Statistical Tools for Process Control and Process Improvement

I. Important Questions Addressed in Continued Process Verification (Stage 3)

II. Statistical Tools and Methods Used to Answer CPV Questions

III. A Systems Approach to the Design and Implementation of Continued Process Verification

IV. Guiding Principles, Tips and Traps for Effective Process Verification Systems

V. Important Questions Addressed in Continued Process Verification (Stage 3)

Ronald D. Snee, PhD
President
Snee Associates, LLC

12:00

Networking Luncheon

90-MINUTE SESSION

1:00

Solo Validation — Applied Lessons in Automation for Statistical Data Collection

Share in the wisdom gained and lessons learned in collecting statistical data for product validation and test using automated or semi-automated methods. Discover new ways of approaching test design and automation to get you to your statistical data more efficiently.

I. Introduction & Understanding the Challenge Driving Automation

II. Determine What Level of Automation for Data Collection to Apply

III. Collect, Clean, Understand & Presenting the Data

IV. Scrappy Results Design: Combining Tools of the trade

V. Fixturing — Do’s & Don’ts

VI. Interactive Exercise

Carl Myhre
Software Engineer
Minnetronix, Inc.

2:30

Close of Conference

Want more agenda details? Download the brochure.

Day One | Tuesday, June 20, 2017

12:00

Conference Registration

1:15

Co-Chairs Welcome and Opening Remarks

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis, Inc.

Marzena Ingram
Manager, Continued Process Verification GSO —
Technical Operations Process Validation
Apotex, Inc.

1:30

FDA Quality Metrics, Data Integrity and Application of Statistics Throughout Process Validation in a Global Economy

Jerry Lanese, PhD
President
The Lanese Group, Inc.

2:15

Understand the Process Validation Lifecycle and the Need for “Fit for Purpose” Statistics

I. Stage I Process Design (ICH Q8(R2) Pharmaceutical Development)

II. Stage II Process Performance Qualification (PPQ)

III. Stage III Continued Process Verification (CPV/OPV)

Marzena Ingram
Manager, Continued Process Verification GSO —
Technical Operations Process Validation
Apotex, Inc.

3:00

Networking and Refreshment Break

3:30 – 5:00

CHOOSE FROM TWO 90-MINUTE SESSIONS (1-2)

SESSION 1 Statistics Bootcamp for the Non-Statistician

I. Know the Statistical Basic Concepts

II. Process Stability and Capability

III. Fundamentals of Design of Experiments (DOE)

IV. Acceptance Sampling Overview

V. Enhance the Power of Communication of Statistical Analysis

Mauricio Chinchilla, M.Eng.
Senior Validation Engineer
Abbott Vascular

SESSION 2 Senior-Level Think Tank — Effective Methods for the Advanced Professional

In this closed-door summit, senior-level computer validation and quality managers from pharmaceutical, biotech and medical device companies engage in open discussions with their colleagues about strategies for managing statistics in validation.

The content for the summit is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss. This session is open to the first twenty senior-level professionals who pre-register for the interactive discussion group.

*To pre-register, you must have over 5 years of experience in CSV execution and currently work for a pharmaceutical, medical device or biotech company. IVT reserves the right to qualify participants for this workshop.

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis, Inc.

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

Day Two | Wednesday, June 21, 2017

7:30

EYE-OPENER BREAKFAST DISCUSSION The Right Statistical Tools and Methods — Solutions to Solve Your Problems in Process Validation

“What statistical tools should I use in process validation?” is an often asked question. A more informative approach is to first identify the problem at hand, then select the appropriate statistical tools and methods to solve the problem. The fundamental principle is that the problem identifies the appropriate statistical tools and methods not the other way around. Using this principle, this presentation examines some of the critical problems addressed in the different stages of process validation and then identifies the various statistical tools that can be used to create the solution.

Ronald D. Snee, PhD
President
Snee Associates, LLC

8:15

Co-Chairs Review of Day One

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis, Inc.

Marzena Ingram
Manager, Continued Process Verification GSO —
Technical Operations Process Validation
Apotex, Inc.

8:30

Improper Use of Statistics — Misuses, Misinterpretation and Bias

Douglas B. Brown, PhD
Research Scientist, Methods Development, Biologics Testing Solutions
Charles River Laboratories, Inc.

9:15

Evolving Trends in the Use of Statistics for Process Validation

Katherine Giacoletti, M.Stat
Partner
SynoloStats

10:00

Networking and Refreshment Break

90-MINUTE SESSION

10:30

Using Statistics that Support Quality by Design (QbD)

I. Define the Goals of QbD

II. Design of Experiments

III. Modelling: Build, Test, Refine, Evaluate

IV. Statistical Quality/Process Control

V. Interactive Exercise

Jordan Collins, PhD
Manager, Statistical Support – Global Research and Development
Apotex, Inc.

12:00

Networking Luncheon

90-MINUTE SESSION

1:15

Determination of Sampling Plans Utilizing Risk Analysis

This session focuses on how to determine sampling plans for validation studies, as well as, how to perform comparative studies to ensure multiple processes are equivalent. The method that will be presented will utilize a combined statistical and risk-based approach that varies the statistical confidence based on the risk components of the system or process being qualified. This approach gives a justification for each sampling plan and will give a high assurance that highly capable processes will meet the criteria.

Jeffrey S. Hanson
Certified Quality Engineer from ASQ,
Manager – Technical Services
Upsher-Smith Laboratories, Inc.

2:45

Networking and Refreshment Break

3:15 – 4:45

CHOOSE FROM TWO 90-MINUTE SESSIONS (3-4)

SESSION 3 Biologics — A Case Study in Non-Normal Data

I. Introduction to Simple Stats with Normal Data

II. Discuss Non-Normal Processing Data

III. Learn How to Perform Simple Non-Normal Process Capability Analysis

IV. Interactive Activity

Edward (Ned) Wyman
Principal Scientist, MS&T/ Validation – Biologics
AstraZeneca – Global Operations

SESSION 4 Understand the Benefit and Danger of Statistical Acceptance Criteria for PPQ

I. Statistical Confidence

II. Use of Statistical Intervals as Acceptance Criteria

III. Interactive Activity

Tara Scherder, MS Statistics, BS Chem E
Partner
SynoloStats

5:00

Close of Day Two

Day Three | Thursday, June 22, 2017

8:00

Continental Breakfast

8:30 – 10:00

CHOOSE FROM TWO 90-MINUTE SESSIONS (5-6)

SESSION 5 Data Science and Ensuring Data Integrity

I. Data Integrity, Data Lifecycle and its Impact to Statistics

II. ALCOA: What Does This Mean to Data Integrity, Data Lifecycle and Statistics

III. Data Integrity’s Impact on Data Mining, Business Intelligence, Data Warehousing and Statistics

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis, Inc.

SESSION 6 Using Statistics to Identify and Understand Process Capability and Control — Statistical Process Control and the Use of Control Charts

This session introduces and discusses the concept and need for process capability and continued process verification using statistics as a tool for quality control. The development of a system to monitor and control processes and procedures assists with enhancing product conformity, reducing waste and identifying product drift and potential loss of system control. A primary focus for process control is to ensure that the behavior of validated processes and procedures has not changed and is continuing to perform as previously described.

I. Process Capability Approach and Process Improvements

II. Statistical Process Control (SPC)

III. Control Charting Basics Using Microsoft Excel

Douglas B. Brown, PhD
Research Scientist, Methods Development, Biologics Testing Solutions
Charles River Laboratories, Inc.

10:00

Networking and Refreshment Break

90-MINUTE SESSION

10:30

Continued Process Verification (CPV) — Statistical Tools for Process Control and Process Improvement

I. Important Questions Addressed in Continued Process Verification (Stage 3)

II. Statistical Tools and Methods Used to Answer CPV Questions

III. A Systems Approach to the Design and Implementation of Continued Process Verification

IV. Guiding Principles, Tips and Traps for Effective Process Verification Systems

V. Important Questions Addressed in Continued Process Verification (Stage 3)

Ronald D. Snee, PhD
President
Snee Associates, LLC

12:00

Networking Luncheon

90-MINUTE SESSION

1:00

Solo Validation — Applied Lessons in Automation for Statistical Data Collection

Share in the wisdom gained and lessons learned in collecting statistical data for product validation and test using automated or semi-automated methods. Discover new ways of approaching test design and automation to get you to your statistical data more efficiently.

I. Introduction & Understanding the Challenge Driving Automation

II. Determine What Level of Automation for Data Collection to Apply

III. Collect, Clean, Understand & Presenting the Data

IV. Scrappy Results Design: Combining Tools of the trade

V. Fixturing — Do’s & Don’ts

VI. Interactive Exercise

Carl Myhre
Software Engineer
Minnetronix, Inc.

2:30

Close of Conference