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Agenda

Industry’s Gold-Standard for Validation Excellence

October 17-19, 2017
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, OCTOBER 17, 2017

11:30

Conference Registration

12:30

Chairperson’s Welcome and Opening Remarks

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

12:45

Emerging Trends in Process Validation Lifecycle Approach

Naheed Sayeed-Desta
Manager, Process Validation
Apotex, Inc.

1:30

Explore the Parallels between Process Validation and Design Verification

Roberta Goode, MSBE, CQE
President
Goode Compliance International

2:15

FDA Inspection Readiness —
Get Ready and Stay Ready to Assure Favorable Inspection Outcomes

Michael Barile
Founder and Managing Partner
Barile & Associates, Inc.

2:45

Networking and Refreshment Break

3:15

CRITICAL CONCEPT SPOTLIGHT
Cybersecurity and Computer Systems Validation — What You Need to Know

Valarie King-Bailey
CEO
OnShore Technology Group, Inc.

4:00

KEYNOTE ADDRESS
Understand and Comply with FDA Requirements and Expectations

In a continuously changing regulatory environment, it is critical to stay in tune with regulation and guidance updates as well as understand what FDA inspectors expect when they conduct an audit. In this regulatory keynote, gain new insights to FDA expectations and key strategies on how to comply with current requirements.

Karyn Campbell
Director, Investigations Branch II, Division of Pharmaceutical Quality Operations I
FDA (Invited)

4:45

Multi-Stakeholder Panel — Ask the Experts Facilitated Q&A

MODERATOR:

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

EXPERTS:

Valarie King-Bailey, MBA
CEO
OnShore Technology Group, Inc.

Karyn Campbell
Director, Investigations Branch II, Division of Pharmaceutical Quality Operations I
FDA (Invited)

Roberta Goode, MSBE, CQE
President
Goode Compliance International

Naheed Sayeed-Desta
Manager, Process Validation
Apotex, Inc.

5:30

AWARDS CEREMONY AND
COCKTAIL RECEPTION
Join us for our annual awards ceremony where we announce the winners of this year’s Author of the Year, Speaker of the Year and Kenneth G. Chapman Award.

7:00

Close of Day One

DAY TWO WEDNESDAY, OCTOBER 18, 2017

8:00

Continental Breakfast

8:10

CHOOSE BETWEEN TWO EYE-OPENER BREAKFAST DISCUSSIONS (A-B)

A MEDICAL DEVICE PERSPECTIVE Due Diligence and Remediation Resulting from Mergers & Acquisitions

The medical device industry is experiencing a surge in mergers and acquisitions. Combining cultures and policies is never simple, but in the case of mis-aligned strategies for V&V, it’s essential to have tools to assess liability and remediation costs. In this interactive session, explore scenarios for determining ROI and planning for riskbased remediation. Identifying where the V&V landmines typically hide out provides attendees with insights to mitigate the risk of unpleasant surprises. Finally, discover what “good” looks like by way of an actual M&A case study from the medical device manufacturing industry.

Roberta Goode, MSBE, CQE
President
Goode Compliance International

 
B The Quality System Maturity Matrix — A Tool for Getting the Executive Suite’s Attention

In this session, participants grade their company’s quality standpoint using a maturity matrix. The facilitator leads participants through the matrix showing how it can be used with every member of the executive suite to connect them with, and engage them in, the quality system.

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd

8:55

Coffee Refresher Break

9:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (1-4)

FUNDAMENTAL

1 Introduction to Statistics in Validation for
the Non-Statistician

I. Introduction

II. The Concept of Variance (and Why It Is Important)

III. Expressing Variance

IV. Process Capability

V. Acceptance Sampling for Validation

VI. Conclusion and Discussion

Alan Golden, MS
Principal Quality Professional, Product Quality Operations Support
Abbott Molecular

2 Establish Effective Strategies for Managing the
Validation Quality System

I. Outline, Definitions and Objectives

II. Define the Validation Function

III. Process Validations and Qualifications

IV. Other Processes

V. Department Management

VI. Positives and Negatives

VII. Interactive Exercise

Paul L. Pluta, PhD
Editor-in-Chief, IVT Network, a division of UBM Americas;
Associate Professor, Biopharmaceutics, University of Illinois at Chicago (UIC)

FUNDAMENTAL

3 Maximize Audit Trail Technical and Business Review Procedures to Comply with Requirements

The FDA has new expectations for how you handle audit trails. Don’t Panic! This presentation goes over what they are looking for and how you can make these new requirements work for you by speeding up the overall QA review process.

I. What Are the New Requirements?

II. Specifics of a Robust Data and Audit Trail Review

Ty Mew
President
Ofni Systems

ADVANCED

4 Develop a Robust Environmental Qualifications Program

I. Overview of an Environmental Qualification Program Design and Regulatory Expectations

II. Validating and Monitoring

III. Interactive Exercise

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (5-8)

FUNDAMENTAL

5 Emerge into the World of Process Validation —
A Brief Guide

I. The Evolution of the Practice of Process Validation

II. A Detailed Look at the Three Stages of Process Validation

III. Integrating Process Validation and the Pharmaceutical Quality System

IV. Interactive Exercise

Jerry Lanese, PhD
President
The Lanese Group, Inc.

ADVANCED

6 Mock Audit —
Refine Preparation Strategies for a Successful Audit

Many companies are under the assumption that their systems are fine, and that things are “in control”, when nothing could be further from the truth. The FDA has increased its focus on enforcement by hiring more investigators and has increased the number of Warning Letters issued. Since companies within the US are subject to FDA inspections without notice (even though they generally follow a rough anticipated schedule), they need to be what I call “ever ready” for an FDA inspection.

I. Validation Regulations

II. Inspection Preparation

III. Back to the Basics

IV. Mock Audits

V. Exercise

Kai Wong
Director, Quality LIMS
Kite Pharma

7 Implementation and Audit Preparation of a
Complex Computer System

I. Challenges during the Implementation of Complex Computer Systems

II. Challenges during the Audit of Complex Computer Systems

III. Strategies during the Implementation of Complex Computer Systems

IV. Audit Preparation Strategies for Complex Computer Systems

Ivan Soto
Director, Client Engagement and Product Strategy
ValGenesis Systems

ADVANCED

8 MEDICAL DEVICE THINK TANK Creative Solutions to Tricky Problems —
Brainstorm Strategic Validation Methods,
When to Use Them and How to Make Them Effective

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about creative strategies for achieving compliant validation in tricky situations (e.g., legacy processes, enforcement actions, acquisitions, etc.). The content for this think tank is driven by participants, who are surveyed ahead of time about the details of the topic. The session is open to the first 15 seniorlevel professionals who preregister for the interactive discussion group. In order to pre-register, you must have over five years of experience in validation and currently work for a medical device or diagnostics company. IVT reserves the right to qualify participants for this workshop.

Roberta Goode, MSBE, CQE
President
Goode Compliance International

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN THREE INTERACTIVE 3-HOUR WORKSHOPS (9-11)*

FUNDAMENTAL

9 Plan and Execute a Successful Test Method Validation (TMV)

I. Understand the Language of Measurement

II. Show the Importance of Measurement

III. Walk Away Knowing How to Perform a Variable and an Attribute TMV and How to Interpret Results

IV. Interactive Exercise

Mohit Malkani
Director of Engineering Services
Bioteknica Inc.

10 Least Burdensome Approach to Data Integrity —
Analyze Recent FDA Warning Letters and 483s

I. Learn the Fundamental Concepts and Principles of Data Integrity (DI)

II. Explore How the “Least Burdensome Approach” Guidance Can Be Applied to Data Integrity

III. Understand the 2-Dimensional Approach to Establishing a Data Integrity Infrastructure

IV. Establish a Criteria to Determine the Data Integrity Health of Your Company

V. Interactive Exercise

Chinmoy Roy
Retiree, Senior Systems Application Engineer
Genentech Inc.

ADVANCED

11 Create and Practice a Risk Assessment and
Establish Acceptance Criteria for Cleaning Validation

I. Understand the Regulations and Regulatory Expectations

II. Learn How to Develop Your Cleaning Validation Acceptance Criteria Risk Assessment

III. Putting Your Planned Cleaning Validation Program in Action

IV. On-Going Monitoring and Support

V. Interactive Exercise

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

*There will be a 30-minute refreshment break at 3:00pm

5:00

Close of Day Two

ALUMNI INVITATION-ONLY NETWORKING RECEPTION IVT Network is hosting an invitation-only networking receptions for previous attendees, speakers, sponsors, writers and IVT Network members to meet peers and fellow IVT Network community colleagues.

DAY THREE THURSDAY, OCTOBER 19, 2017

8:00

Continental Breakfast

8:10

CHOOSE BETWEEN TWO EYE-OPENER BREAKFAST DISCUSSIONS (C-D)

C Implement a Well-Defined Validation Program on a Limited Budget

The cost of validation is an ongoing topic of discussion. Typical validation costs can run upward of 25% of total project cost!

I. The Cost of Validation

II. Implement a Well-Rounded System

III. Apply Lean Concepts to Your Validation Program

Kristin Shuler
Senior Validation Engineer
Cedarburg Pharmaceuticals,
a Division of AMRI

 
D Explore Automated Cleaning Validation Techniques

The process of performing a cleaning validation with a paper-based system is labor intensive and error prone. This presentation discusses an automated approach to cleaning validation using computer software for managing the entire process.

Parsa Famili
President and CEO
Novatek International

8:55

Coffee Refresher Break

9:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (12-15)

12 Design Sampling Plans that Align with
Global Regulatory Expectations

I. What Is Sampling?

II. Validation Sampling

III. Set Up a Validation Sampling Plan

IV. Statistical Process Controls

Alan Golden, MS
Principal Quality Professional, Product Quality Operations Support
Abbott Molecular

13 Incorporate Risk-Based Change Control —
Update on ICH Q12 Implementation

I. History and Future of ICH Q12

II. Post-Approval Change Management

III. How to Implement Risk-Based Change Management

Speaker TBA

FUNDAMENTAL

14 Determine Expectations and Requirements for
Data Integrity in Paper-Based vs. Paperless Systems

I. Paper-Based System Expectations and Requirements

II. Paperless System Expectations and Requirements

III. Data Integrity

Michael Wolff
Validation Engineer
Tidi Products

ADVANCED

15 BIO/PHARMACEUTICAL THINK TANK Collaborate to Develop Valuable Strategies for
the Advanced Professional

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about challenges, experiences and strategies for efficient processes. The content for this think tank is driven by participants, who are surveyed ahead of time about the details of the topic. The session is open to the first 15 senior-level professionals who preregister for the interactive discussion group. In order to pre-register, you must have over five years of experience in validation and currently work for a pharmaceutical or biotechnology company. IVT reserves the right to qualify participants for this workshop.

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd

Lizzandra Rivera
Senior Manager, IT Quality
Alexion Pharmaceuticals, Inc.

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (16-19)

FUNDAMENTAL

16 How to Draft an Effective Validation Master Plan (VMP) — The Do’s and the Don’ts

I. Why Do We Need a VMP?

II. Developing a VMP

III. Interactive Exercise

Connie Hetzler
Global Validation Head
Alere, Inc.

ADVANCED

17 CASE STUDY Build a Quality Culture and Incorporate into
Business Strategy

I. What Is Old... Is New

II. The Quality Culture Journey — Case Study

III. Interactive Exercise

Tanya Fletcher-Scott, BS
Chemical Engineering, Director of Quality
Dendreon Pharmaceuticals

ADVANCED

18 A Practical Approach for Transitioning to an
Agile Software Development Model in a
Regulated Environment

I. Agile Software Development Model

II. Regulatory Expectations for Software Development

III. Agile vs. Waterfall

IV. Incorporate a Risk-Based Approach in Agile

V. Benefits and Challenges

Jim Gunning
Director, Quality CSV
Johnson & Johnson

FUNDAMENTAL

19 Address Global Challenges in Cleaning Validation
for 2017-2018

I. Outline, Definitions and Objectives

II. Product Problems

III. Equipment-Related Problems

IV. Cleaning Process Problems

V. Laboratory Problems

VI. Management and Staff

VII. Interactive Exercise — Self-Audit Questions

Paul L. Pluta, PhD
Editor-in-Chief, IVT Network, a division of UBM Americas;
Associate Professor, Biopharmaceutics, University of Illinois at Chicago (UIC)

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (20-23)

FUNDAMENTAL

20 Next Generation Validation Process Concepts —
Case Study on Application of the Process

I. Introduction to Next Generation Validation Concept

II. System and Support

III. Case Study — Application of the Process

Lou Killian
Director of Customer Success
Kneat Solutions

FUNDAMENTAL

21 Prepare for a Successful Supplier Quality Audit

I. Regulatory Overview

II. Preparing for the Audit

III. Interactive Exercise

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd

ADVANCED

22 Prepare Your Laboratory for a Data Integrity Audit

I. Brief Overview of Data Integrity and Regulatory Focus

II. Data Integrity Compliance and AIQ

III. Common Data Integrity Issues

IV. Auditors Checklist

Miguel Pagan
Senior Compliance Consultant
Agilent Technologies

23 Legacy System Risk Review

This session describes and evaluates the risk involved in equipment systems (not process related) that are legacy (systems that are not compliant to current requirements) on-site. The course also assists in mitigating the risks through data analysis and quality systems (CAPA, customer complaints, change control, etc.) to provide focus on compliancy risk.

I. Risk Evaluation

II. Data Analysis

III. Compliancy Risk Report

IV. Address Compliancy Gaps

V. Interactive Exercise

Jayme Richter
QA Validation Manager
B. Braun Medical Inc.

Michael Cole
QA Validation Specialist III
B. Braun Medical Inc.

2:45

Networking Refreshment Break

3:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (24-27)

FUNDAMENTAL

24 Incorporate Process Validation Principles to the Entire Validation Program

I. Process Validation Principles

II. Impact of the Pharmaceutical Quality System

III. The Validation Program

IV. Interactive Exercise

Jerry Lanese, PhD
President
The Lanese Group, Inc.

FUNDAMENTAL

25 Apply a Step-by-Step Implementation of Quality by Design (QbD) into Validation Processes

What is Quality by Design (QbD) and why do you care about it for validation activities? Do you experience schedule over-runs or unproductive delays? QbD leads a proactive approach to process design and development. In this session, take the fundamentals of QbD and apply them to validation projects.

I. Introduction — What Is Quality by Design?

II. Validation Opportunities

III. Challenges and Benefits to Adopting the QbD Philosophy

IV. Interactive Exercise

Kristin Shuler
Senior Validation Engineer
Cedarburg Pharmaceuticals, a Division of AMRI

ADVANCED

26 Real-Life Examples of Implementing Data Integrity Concepts into Operational Procedures

I. Data Integrity Procedural Controls

II. Writing Actionable Procedures to Support Your Data Integrity Program

III. Confirming Effectiveness

Lizzandra Rivera
Senior Manager, IT Quality
Alexion Pharmaceuticals, Inc.

27 Master Equipment Qualification to Ensure
“Fit for Intended Use”

I. Regulatory Requirements

II. Challenges with Traditional Equipment Qualification

III. Equipment User Requirements — Why Are They Important?

IV. Strategies to Implement a Robust Equipment Qualification Program

Ivan Soto
Director, Client Engagement and Product Strategy
ValGenesis Systems

4:15

CHOOSE YOUR COLLABORATIVE CLOSING POWER HOUR (28-31)

The closing power hours are an opportunity for conclusive discussions to regroup on strategies and best practices shared throughout the conference, respond to unanswered questions and exchange ideas on how to face tough problems. The discussion leaders of each topic area take notes on hot topics and frequently asked questions throughout the meeting to be prepared to facilitate and offer insight to key challenges at the power hour.

SESSION 28 Process Validation Power Hour

Paul L. Pluta, PhD
Editor-in-Chief,
IVT Network, a division of UBM Americas;
Associate Professor, Biopharmaceutics, University of Illinois at Chicago (UIC)

SESSION 29 Quality Power Hour

Alan Golden, MS
Principal Quality Professional,
Product Quality Operations Support
Abbott Molecular

SESSION 30 CSV/Data Integrity Power Hour

Lizzandra Rivera
Senior Manager, IT Quality
Alexion Pharmaceuticals, Inc.

Kai Wong
Director, Quality LIMS
Kite Pharma

SESSION 31 Cleaning Validation Power Hour

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

5:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE TUESDAY, OCTOBER 17, 2017

11:30

Conference Registration

12:30

Chairperson’s Welcome and Opening Remarks

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

12:45

Emerging Trends in Process Validation Lifecycle Approach

Naheed Sayeed-Desta
Manager, Process Validation
Apotex, Inc.

1:30

Explore the Parallels between Process Validation and Design Verification

Roberta Goode, MSBE, CQE
President
Goode Compliance International

2:15

FDA Inspection Readiness —
Get Ready and Stay Ready to Assure Favorable Inspection Outcomes

Michael Barile
Founder and Managing Partner
Barile & Associates, Inc.

2:45

Networking and Refreshment Break

3:15

CRITICAL CONCEPT SPOTLIGHT
Cybersecurity and Computer Systems Validation — What You Need to Know

Valarie King-Bailey
CEO
OnShore Technology Group, Inc.

4:00

KEYNOTE ADDRESS
Understand and Comply with FDA Requirements and Expectations

In a continuously changing regulatory environment, it is critical to stay in tune with regulation and guidance updates as well as understand what FDA inspectors expect when they conduct an audit. In this regulatory keynote, gain new insights to FDA expectations and key strategies on how to comply with current requirements.

Karyn Campbell
Director, Investigations Branch II, Division of Pharmaceutical Quality Operations I
FDA (Invited)

4:45

Multi-Stakeholder Panel — Ask the Experts Facilitated Q&A

MODERATOR:

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

EXPERTS:

Valarie King-Bailey, MBA
CEO
OnShore Technology Group, Inc.

Karyn Campbell
Director, Investigations Branch II, Division of Pharmaceutical Quality Operations I
FDA (Invited)

Roberta Goode, MSBE, CQE
President
Goode Compliance International

Naheed Sayeed-Desta
Manager, Process Validation
Apotex, Inc.

5:30

AWARDS CEREMONY AND
COCKTAIL RECEPTION
Join us for our annual awards ceremony where we announce the winners of this year’s Author of the Year, Speaker of the Year and Kenneth G. Chapman Award.

7:00

Close of Day One

DAY TWO WEDNESDAY, OCTOBER 18, 2017

8:00

Continental Breakfast

8:10

CHOOSE BETWEEN TWO EYE-OPENER BREAKFAST DISCUSSIONS (A-B)

A MEDICAL DEVICE PERSPECTIVE Due Diligence and Remediation Resulting from Mergers & Acquisitions

The medical device industry is experiencing a surge in mergers and acquisitions. Combining cultures and policies is never simple, but in the case of mis-aligned strategies for V&V, it’s essential to have tools to assess liability and remediation costs. In this interactive session, explore scenarios for determining ROI and planning for riskbased remediation. Identifying where the V&V landmines typically hide out provides attendees with insights to mitigate the risk of unpleasant surprises. Finally, discover what “good” looks like by way of an actual M&A case study from the medical device manufacturing industry.

Roberta Goode, MSBE, CQE
President
Goode Compliance International

 
B The Quality System Maturity Matrix — A Tool for Getting the Executive Suite’s Attention

In this session, participants grade their company’s quality standpoint using a maturity matrix. The facilitator leads participants through the matrix showing how it can be used with every member of the executive suite to connect them with, and engage them in, the quality system.

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd

8:55

Coffee Refresher Break

9:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (1-4)

FUNDAMENTAL

1 Introduction to Statistics in Validation for
the Non-Statistician

I. Introduction

II. The Concept of Variance (and Why It Is Important)

III. Expressing Variance

IV. Process Capability

V. Acceptance Sampling for Validation

VI. Conclusion and Discussion

Alan Golden, MS
Principal Quality Professional, Product Quality Operations Support
Abbott Molecular

2 Establish Effective Strategies for Managing the
Validation Quality System

I. Outline, Definitions and Objectives

II. Define the Validation Function

III. Process Validations and Qualifications

IV. Other Processes

V. Department Management

VI. Positives and Negatives

VII. Interactive Exercise

Paul L. Pluta, PhD
Editor-in-Chief, IVT Network, a division of UBM Americas;
Associate Professor, Biopharmaceutics, University of Illinois at Chicago (UIC)

FUNDAMENTAL

3 Maximize Audit Trail Technical and Business Review Procedures to Comply with Requirements

The FDA has new expectations for how you handle audit trails. Don’t Panic! This presentation goes over what they are looking for and how you can make these new requirements work for you by speeding up the overall QA review process.

I. What Are the New Requirements?

II. Specifics of a Robust Data and Audit Trail Review

Ty Mew
President
Ofni Systems

ADVANCED

4 Develop a Robust Environmental Qualifications Program

I. Overview of an Environmental Qualification Program Design and Regulatory Expectations

II. Validating and Monitoring

III. Interactive Exercise

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (5-8)

FUNDAMENTAL

5 Emerge into the World of Process Validation —
A Brief Guide

I. The Evolution of the Practice of Process Validation

II. A Detailed Look at the Three Stages of Process Validation

III. Integrating Process Validation and the Pharmaceutical Quality System

IV. Interactive Exercise

Jerry Lanese, PhD
President
The Lanese Group, Inc.

ADVANCED

6 Mock Audit —
Refine Preparation Strategies for a Successful Audit

Many companies are under the assumption that their systems are fine, and that things are “in control”, when nothing could be further from the truth. The FDA has increased its focus on enforcement by hiring more investigators and has increased the number of Warning Letters issued. Since companies within the US are subject to FDA inspections without notice (even though they generally follow a rough anticipated schedule), they need to be what I call “ever ready” for an FDA inspection.

I. Validation Regulations

II. Inspection Preparation

III. Back to the Basics

IV. Mock Audits

V. Exercise

Kai Wong
Director, Quality LIMS
Kite Pharma

7 Implementation and Audit Preparation of a
Complex Computer System

I. Challenges during the Implementation of Complex Computer Systems

II. Challenges during the Audit of Complex Computer Systems

III. Strategies during the Implementation of Complex Computer Systems

IV. Audit Preparation Strategies for Complex Computer Systems

Ivan Soto
Director, Client Engagement and Product Strategy
ValGenesis Systems

ADVANCED

8 MEDICAL DEVICE THINK TANK Creative Solutions to Tricky Problems —
Brainstorm Strategic Validation Methods,
When to Use Them and How to Make Them Effective

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about creative strategies for achieving compliant validation in tricky situations (e.g., legacy processes, enforcement actions, acquisitions, etc.). The content for this think tank is driven by participants, who are surveyed ahead of time about the details of the topic. The session is open to the first 15 seniorlevel professionals who preregister for the interactive discussion group. In order to pre-register, you must have over five years of experience in validation and currently work for a medical device or diagnostics company. IVT reserves the right to qualify participants for this workshop.

Roberta Goode, MSBE, CQE
President
Goode Compliance International

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN THREE INTERACTIVE 3-HOUR WORKSHOPS (9-11)*

FUNDAMENTAL

9 Plan and Execute a Successful Test Method Validation (TMV)

I. Understand the Language of Measurement

II. Show the Importance of Measurement

III. Walk Away Knowing How to Perform a Variable and an Attribute TMV and How to Interpret Results

IV. Interactive Exercise

Mohit Malkani
Director of Engineering Services
Bioteknica Inc.

10 Least Burdensome Approach to Data Integrity —
Analyze Recent FDA Warning Letters and 483s

I. Learn the Fundamental Concepts and Principles of Data Integrity (DI)

II. Explore How the “Least Burdensome Approach” Guidance Can Be Applied to Data Integrity

III. Understand the 2-Dimensional Approach to Establishing a Data Integrity Infrastructure

IV. Establish a Criteria to Determine the Data Integrity Health of Your Company

V. Interactive Exercise

Chinmoy Roy
Retiree, Senior Systems Application Engineer
Genentech Inc.

ADVANCED

11 Create and Practice a Risk Assessment and
Establish Acceptance Criteria for Cleaning Validation

I. Understand the Regulations and Regulatory Expectations

II. Learn How to Develop Your Cleaning Validation Acceptance Criteria Risk Assessment

III. Putting Your Planned Cleaning Validation Program in Action

IV. On-Going Monitoring and Support

V. Interactive Exercise

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

*There will be a 30-minute refreshment break at 3:00pm

5:00

Close of Day Two

ALUMNI INVITATION-ONLY NETWORKING RECEPTION IVT Network is hosting an invitation-only networking receptions for previous attendees, speakers, sponsors, writers and IVT Network members to meet peers and fellow IVT Network community colleagues.

DAY THREE THURSDAY, OCTOBER 19, 2017

8:00

Continental Breakfast

8:10

CHOOSE BETWEEN TWO EYE-OPENER BREAKFAST DISCUSSIONS (C-D)

C Implement a Well-Defined Validation Program on a Limited Budget

The cost of validation is an ongoing topic of discussion. Typical validation costs can run upward of 25% of total project cost!

I. The Cost of Validation

II. Implement a Well-Rounded System

III. Apply Lean Concepts to Your Validation Program

Kristin Shuler
Senior Validation Engineer
Cedarburg Pharmaceuticals,
a Division of AMRI

 
D Explore Automated Cleaning Validation Techniques

The process of performing a cleaning validation with a paper-based system is labor intensive and error prone. This presentation discusses an automated approach to cleaning validation using computer software for managing the entire process.

Parsa Famili
President and CEO
Novatek International

8:55

Coffee Refresher Break

9:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (12-15)

12 Design Sampling Plans that Align with
Global Regulatory Expectations

I. What Is Sampling?

II. Validation Sampling

III. Set Up a Validation Sampling Plan

IV. Statistical Process Controls

Alan Golden, MS
Principal Quality Professional, Product Quality Operations Support
Abbott Molecular

13 Incorporate Risk-Based Change Control —
Update on ICH Q12 Implementation

I. History and Future of ICH Q12

II. Post-Approval Change Management

III. How to Implement Risk-Based Change Management

Speaker TBA

FUNDAMENTAL

14 Determine Expectations and Requirements for
Data Integrity in Paper-Based vs. Paperless Systems

I. Paper-Based System Expectations and Requirements

II. Paperless System Expectations and Requirements

III. Data Integrity

Michael Wolff
Validation Engineer
Tidi Products

ADVANCED

15 BIO/PHARMACEUTICAL THINK TANK Collaborate to Develop Valuable Strategies for
the Advanced Professional

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about challenges, experiences and strategies for efficient processes. The content for this think tank is driven by participants, who are surveyed ahead of time about the details of the topic. The session is open to the first 15 senior-level professionals who preregister for the interactive discussion group. In order to pre-register, you must have over five years of experience in validation and currently work for a pharmaceutical or biotechnology company. IVT reserves the right to qualify participants for this workshop.

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd

Lizzandra Rivera
Senior Manager, IT Quality
Alexion Pharmaceuticals, Inc.

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (16-19)

FUNDAMENTAL

16 How to Draft an Effective Validation Master Plan (VMP) — The Do’s and the Don’ts

I. Why Do We Need a VMP?

II. Developing a VMP

III. Interactive Exercise

Connie Hetzler
Global Validation Head
Alere, Inc.

ADVANCED

17 CASE STUDY Build a Quality Culture and Incorporate into
Business Strategy

I. What Is Old... Is New

II. The Quality Culture Journey — Case Study

III. Interactive Exercise

Tanya Fletcher-Scott, BS
Chemical Engineering, Director of Quality
Dendreon Pharmaceuticals

ADVANCED

18 A Practical Approach for Transitioning to an
Agile Software Development Model in a
Regulated Environment

I. Agile Software Development Model

II. Regulatory Expectations for Software Development

III. Agile vs. Waterfall

IV. Incorporate a Risk-Based Approach in Agile

V. Benefits and Challenges

Jim Gunning
Director, Quality CSV
Johnson & Johnson

FUNDAMENTAL

19 Address Global Challenges in Cleaning Validation
for 2017-2018

I. Outline, Definitions and Objectives

II. Product Problems

III. Equipment-Related Problems

IV. Cleaning Process Problems

V. Laboratory Problems

VI. Management and Staff

VII. Interactive Exercise — Self-Audit Questions

Paul L. Pluta, PhD
Editor-in-Chief, IVT Network, a division of UBM Americas;
Associate Professor, Biopharmaceutics, University of Illinois at Chicago (UIC)

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (20-23)

FUNDAMENTAL

20 Next Generation Validation Process Concepts —
Case Study on Application of the Process

I. Introduction to Next Generation Validation Concept

II. System and Support

III. Case Study — Application of the Process

Lou Killian
Director of Customer Success
Kneat Solutions

FUNDAMENTAL

21 Prepare for a Successful Supplier Quality Audit

I. Regulatory Overview

II. Preparing for the Audit

III. Interactive Exercise

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd

ADVANCED

22 Prepare Your Laboratory for a Data Integrity Audit

I. Brief Overview of Data Integrity and Regulatory Focus

II. Data Integrity Compliance and AIQ

III. Common Data Integrity Issues

IV. Auditors Checklist

Miguel Pagan
Senior Compliance Consultant
Agilent Technologies

23 Legacy System Risk Review

This session describes and evaluates the risk involved in equipment systems (not process related) that are legacy (systems that are not compliant to current requirements) on-site. The course also assists in mitigating the risks through data analysis and quality systems (CAPA, customer complaints, change control, etc.) to provide focus on compliancy risk.

I. Risk Evaluation

II. Data Analysis

III. Compliancy Risk Report

IV. Address Compliancy Gaps

V. Interactive Exercise

Jayme Richter
QA Validation Manager
B. Braun Medical Inc.

Michael Cole
QA Validation Specialist III
B. Braun Medical Inc.

2:45

Networking Refreshment Break

3:00

CHOOSE BETWEEN FOUR 90-MINUTE SESSIONS (24-27)

FUNDAMENTAL

24 Incorporate Process Validation Principles to the Entire Validation Program

I. Process Validation Principles

II. Impact of the Pharmaceutical Quality System

III. The Validation Program

IV. Interactive Exercise

Jerry Lanese, PhD
President
The Lanese Group, Inc.

FUNDAMENTAL

25 Apply a Step-by-Step Implementation of Quality by Design (QbD) into Validation Processes

What is Quality by Design (QbD) and why do you care about it for validation activities? Do you experience schedule over-runs or unproductive delays? QbD leads a proactive approach to process design and development. In this session, take the fundamentals of QbD and apply them to validation projects.

I. Introduction — What Is Quality by Design?

II. Validation Opportunities

III. Challenges and Benefits to Adopting the QbD Philosophy

IV. Interactive Exercise

Kristin Shuler
Senior Validation Engineer
Cedarburg Pharmaceuticals, a Division of AMRI

ADVANCED

26 Real-Life Examples of Implementing Data Integrity Concepts into Operational Procedures

I. Data Integrity Procedural Controls

II. Writing Actionable Procedures to Support Your Data Integrity Program

III. Confirming Effectiveness

Lizzandra Rivera
Senior Manager, IT Quality
Alexion Pharmaceuticals, Inc.

27 Master Equipment Qualification to Ensure
“Fit for Intended Use”

I. Regulatory Requirements

II. Challenges with Traditional Equipment Qualification

III. Equipment User Requirements — Why Are They Important?

IV. Strategies to Implement a Robust Equipment Qualification Program

Ivan Soto
Director, Client Engagement and Product Strategy
ValGenesis Systems

4:15

CHOOSE YOUR COLLABORATIVE CLOSING POWER HOUR (28-31)

The closing power hours are an opportunity for conclusive discussions to regroup on strategies and best practices shared throughout the conference, respond to unanswered questions and exchange ideas on how to face tough problems. The discussion leaders of each topic area take notes on hot topics and frequently asked questions throughout the meeting to be prepared to facilitate and offer insight to key challenges at the power hour.

SESSION 28 Process Validation Power Hour

Paul L. Pluta, PhD
Editor-in-Chief,
IVT Network, a division of UBM Americas;
Associate Professor, Biopharmaceutics, University of Illinois at Chicago (UIC)

SESSION 29 Quality Power Hour

Alan Golden, MS
Principal Quality Professional,
Product Quality Operations Support
Abbott Molecular

SESSION 30 CSV/Data Integrity Power Hour

Lizzandra Rivera
Senior Manager, IT Quality
Alexion Pharmaceuticals, Inc.

Kai Wong
Director, Quality LIMS
Kite Pharma

SESSION 31 Cleaning Validation Power Hour

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

5:15

Close of Conference