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Agenda

Paving the Way to Validation Excellence

October 16-18, 2019
  • Las Vegas, NV

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, OCTOBER 16, 2019

3nd Annual Women in Validation Empowerment Summit

9:00

Summit Check-In and Welcome Refreshments

9:30

PANEL Paving the Way for Women in Validation and Quality

MODERATOR:

Connie Hetzler
Global Validation Head
Alcon Labs

PANEL:

Lizzandra Rivera
Assistant Director Quality – Systems,
Standards and Compliance, CSV Program Manager
Alexion

Kimberly A. Trautman, MS
Executive Vice President Medical Device International Services
NSF Medical Devices

Michelle Hickey
Director, Validation
Clovis Oncology

10:30

TABLE TALKS

11:30

Close of Summit and Lunch for Summit Participants

11:30

Main Conference Registration

12:30

Conference Chair’s Welcome and Opening Remarks

Praveen Kalluri
Director, Quality Assurance – Computer System Validation
PTC Therapeutics

REGULATORY SHOWCASE Insight from the FDA ORA Medical Devices and Pharmaceuticals — Learn from
Recent Inspections to Increase Efficiencies and Decrease Violations

12:45

FDA ORA Medical Devices Spotlight

Raymond W. Brullo, MD, DPM
Compliance Officer, Office of Medical Devices and Radiological
Health Operations Div. 3, Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration (USFDA) (Invited)

1:30

Explore the Convergence of Global Regulatory Trends Impacting Quality Management

Kimberly A. Trautman, MS
Executive Vice President Medical Device International Services
NSF Medical Devices

2:15

Game Changer! Update on FDA and Industry Collaboration on
Computer Software Assurance (CSA)

MODERATOR:

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

PANELISTS:

Ken Shitamoto
Senior Director, IT
Gilead

Francisco Vicenty
Program Manager, Case for Quality Center for Devices and Radiological Health
U.S. Food and Drug Administration

Shana Kinney
Senior Manager, Computer Systems Validation
REGENXBIO Inc.

Stephen Cook
Senior Quality Manager
Compliance Group

Harsha Chulki
Senior Validation Manager
ICU Medical

3:15

Networking and Refreshment Break

3:45

Cell Therapy Manufacturing Facility Design, Construction and Validation

William Johnson
Director Facilities & Validation
Bellicum Pharmaceuticals

4:30

Advanced Therapy Medicinal Products (ATMPs) —
A Journey into Uncharted Territory

Javier Cardenas, PhD
Senior Consultant
Azzur Group

5:15

Go Lean! Mastering the Principles and Best Practices of Lean Validation

Valarie King-Bailey, MBA
Chief Executive Officer
OnShore Technology Group, Inc.

6:00

IVT Awards Ceremony

6:30

Close of Day One

NETWORKING RECEPTION immediately following the awards ceremony

DAY TWO THURSDAY, OCTOBER 17, 2019

8:00

Continental Breakfast

8:30

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (1-4)

VALIDATION
ESSENTIALS

1 Drive Process Understanding through Optimized Process Validation and Qualification

I. Review How the Product Lifecycle Links with the Most Recent Process Validation Lifecycle as Defined by the Main Regulatory Bodies

II. Demonstrate an Understanding of the Interactions Between Process Understanding and Process Validation

III. Case Study #1 — Process Understanding in a
Bulk Biotech plant leading to a successful Process Validation

IV. Case Study #2 —
How a challenging Process Validation for a Biotechnology Drug Product influenced Process Understanding for subsequent products in the pipeline

V. Interactive Activity

Gerardo Gómez, PhD
Senior Manager Business Development
PharmaLex

QUALITY CONTROL
& COMPLIANCE

2URS & Implementation of Risk-Based Cleaning Validation Management System

Learning Goals:

I. Manual Systems vs. Computerized Systems

II. Benefits of Compliant Computerized Cleaning Validation Software System

III. Components of a Compliant Cleaning Validation System

IV. Cleaning Validation User Requirements Based on Inherent Risks

V. New FDA Draft Guideline “DATA Integrity”

VI. Supplier Qualification

VII. Implementation, Validation and Training

VIII. Q&A

Parsa Famili, MSc
President & CEO
Novatek International

CSV & IT

3 Pragmatic CSV —
Risk-Based Testing and Documentation

I. Background

II. Non-product Computer System Validation (NP CSV)

III. System-level Risk (SLR)

IV. Interactive Exercise

V. Leveraging Software Quality Assurance (SQA)

VI. Next Steps

Ken Shitamoto
Senior Director, IT
Gilead

Senthil Gurumoorthi
Associate Director
Gilead

MANUFACTURING
& PRODUCTION

4 Develop a Strategic Plan for Facilities Design, Qualification and Validation

I. Facilities Validations Overview

II. Types of Facilities Validations

III. Executing and Documenting Facilities Validations

IV. Q&As and Lessons Learned

Mauricio Chinchilla Romero
Senior Quality Engineer
Edwards Lifesciences

10:00

Brief Refreshment Break

10:30

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (5-8)

VALIDATION
ESSENTIALS

5 Develop a Strategic Lifecycle Approach to
Validation and Risk Management

I. Mapping the Lifecycle

II. Risk Identification in the Lifecycle

III. Integrating Your Risk Management Program into a Meaningful Strategy

IV. Interactive Activity

Connie Hetzler
Global Validation Head
Alcon Labs

QUALITY CONTROL
& COMPLIANCE

6 Integrate Quality-by-Design Lifecycle into Process Validation, Qualification and Quality Systems

Learning Goals:

I. Outline, Definitions and Objectives

II. Define QbD and Lifecycle to Process Validation

III. Apply QbD/Lifecycle to Other Pharma Processes

IV. Analyze and Apply QbD/Lifecycle to Equipment and Other Qualification

V. Apply QbD/Lifecycle to Quality System Applications

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT and Informa Connect;
Managing Director, Lifecycle Compliance Systems

CSV & IT

7 Take the Fear Out of Change Control in CSV & IT

Learning Goals:

I. Change Control — Why? Understand Change Control and
How to Ensure the Process Remains in Control

II. Understanding the Differences between Change Classification and Assessments

III. Navigate Application Changes and Security/Patch Updates

IV. Our Change Control vs. their Change Control —
On Prem Systems vs. Cloud Solutions

V. Case Study —
Evaluate Types of Changes One May Encounter and How to Deal with Them

Lizzandra Rivera, AD
Quality – Systems, Standards and Compliance
Alexion Pharmaceuticals

MANUFACTURING
& PRODUCTION

8Mastering Automated Validation Testing —
Principles and Best Practices

Learning Goals:

I. Test Automation Trends

II. Regulatory Considerations

III. IV&V Testing Principles and Best Practices

IV. Considerations for Automation — A Holistic vs. Tool Approach

V. Case Study — Applied Automated Validation Strategies for an ERP Project

Valarie King-Bailey, MBA
Chief Executive Officer
OnShore Technology Group, Inc.

12:00

Networking Luncheon

1:15

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (9-12)

VALIDATION
ESSENTIALS

9 Validation Master Planning — A Risk-Based Approach

I. ICH Q9 and Quality Risk Management and The Risk Priority Number (RPN)

II. FDA’s View of the Importance of Risk Management in GMP Compliance and Validation

III. Applying Risk Management to the Validation Process and Developing a Master Plan

Gamal Amer
Principal
Premier Compliance Services

QUALITY CONTROL
& COMPLIANCE

10 Human Error Reduction in Validation Activities —
A CAPA Approach

The cost of human error to the life sciences industry results in billions of dollars in lost revenue annually, in addition to products and services that never make it to market. Understanding the root causes of mistakes that people make through looking at the human performance model is one of the first steps that must be taken to address investigations and deviations that are associated with validation-related activities.

Interactive Activity

Willis Thomas, PhD, PMP, CPT
Editorial Advisory Board Member
Journal of Validation Technology and Journal of GXP Compliance

CSV & IT

11 Streamlined Integrated IT Governance, to Eliminate Redundancies, Improve Quality, and Enhance Compliance

Stephen Cook
Senior Quality Manager
Compliance Group

Harsha Chulki
Senior Validation Manager
ICU Medical

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

MANUFACTURING
& PRODUCTION

12 Global Problems in Cleaning Validation — 2019

Learning Goals:

I. Outline, Definitions and Objectives

II. Discuss API and Product-Related Problems

III. Describe Equipment-Related Cleaning Problems

IV. Analyze Cleaning Process Problems

V. Discuss and Describe Analytical Laboratory Problems

VI. Management and Staff Problems

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT and Informa Connect;
Managing Director, Lifecycle Compliance Systems

2:45

Networking and Refrshment Break

3:15

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (13-16)

VALIDATION
ESSENTIALS

13 Pragmatic Approaches to Third-Party Risk Management and Validation Oversight

I. What Are Quality Agreements?

II. Developing a Quality Agreement

III. Interactive Exercise

Crystal Booth, M.M.
Regional Manager
PSC Biotech

QUALITY CONTROL
& COMPLIANCE

14 Achieve Outstanding Productivity Results in the
QC Lab with an EVLMS Approach

Practical guide with case studies to implement an efficient and compliant e-validation EVLMS solution for lab asset lifecycle management.

Lou Killian
Director Customer Education & Success
Kneat Software

CSV & IT

15 Bring Your Own Data Integrity Challenge

In recent years, data integrity has become a hot issue for regulators. The number of citations of data integrity lapses has increased worldwide as regulators focus in on this important practice. In this interactive session, attendees are encouraged to submit their own data integrity challenges, real issues they face on a regular basis in their work. Together, we will discuss these challenges and propose solutions that hopefully will help all in the vital effort of increasing data integrity levels in all areas of our profession.

Lizzandra Rivera
Associate Director IT Quality
Alexion

MANUFACTURING
& PRODUCTION

16 Cleanrooms On-Demand, a Paradigm Shift in
Early Phase Bio/Pharmaceutical Manufacturing

With increasing demands for manufacturing space and GMP capabilities, an alternate option to contract manufacturing and/or in-house manufacturing is now available to the bio/pharma and related industries. This talk details this new manufacturing option for pre-clinical or early phase clinical companies. The talk also provides Azzur’s approach to qualification/validation of this new manufacturing option.

Ravi Samavedam
General Manager
Azzur Group

3:00

Networking and Refreshment Break

4:15

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (17-20)

VALIDATION
ESSENTIALS

17 Maintenance of the Validated State for Commercial Manufacturing Processes

Learning Goals:

I. Review Lifecycle Approach for Process Validation focused on Validation Maintenance and CPV

II. Identify Applicable Global Regulations and Guidance

III. Explore Approaches to Implementation of a Validation Maintenance Program

IV. Identify Best Practices and Challenges

V. Live Benchmarking Poll (results will be compiled and shared with participants)

Michelle Hickey
Director, Validation
Clovis Oncology

QUALITY CONTROL
& COMPLIANCE

18 Develop Effective Tools and Tactics for Audit Preparation

J. Sean Osso
Quality Engineer – Expert
Agilent Technologies

CSV & IT

19 Arrival of a New Era in Validation

Learning Goals:

I. Significance of Data Integrity

II. Risk Evaluation Strategies

III. Compliance Factors for Cloud Validation

IV. Embedded Systems in Equipment Validation

V. Importance of Periodic Reviews

VI. Clear Definition of Roles and Responsibilities

VII. Systems Audit Process

VIII. Interactive Discussion

Praveen Kalluri
Director, Quality Assurance – Computer System Validation
PTC Therapeutics

MANUFACTURING
& PRODUCTION

20 Practical Approaches to Supply Chain Validation
and Verification

I. Supply Chain Management

II. Verification of the Supply Chain

III. Validation of the Supply Chain

IV. The Future

Gamal Amer
Principal
Premier Compliance Services

5:15

Close of Day Two

DAY THREE FRIDAY, OCTOBER 18, 2019

7:30

Continental Breakfast

8:00

CHOOSE BETWEEN FOUR WORKSHOPS (A-D)

A Patient-Focused Statistics in Process Validation — Tips and Techniques for the A Non-Statistician

I. Statistics throughout the Process Validation Lifecycle — Overview

II. Optimal Sampling Plans to Demonstrate Performance in Stage 2 of Process Validation

III. Efficient Sampling Plans for Monitoring in Stage 3 of Process Validation

IV. Common Misconceptions about Statistics

V. The Power of Data Visualization

Katherine Giacoletti, MStat
Partner
SynoloStats LLC

B Leverage Data Integrity Audits to Eliminate 483s and Warning Letter Observations

Learning Goals:

I. Review of Typical Data Integrity Related 483s and Warning Letters

II. Discuss Route Cause of these Observations

III. Incorporating Learnings into Data Integrity Program

IV. Conducting Data Integrity Audits/Assessments

IV. Case Study — Conduct a Laboratory Data Integrity Assessment

Chris Wubbolt
Principal
QACV BioPharma Group

II. Mock Audit

Willis Thomas, PhD, PMP, CPT
Editorial Advisory Board Member
Journal of Validation Technology and Journal of GXP Compliance

C Design Control —
Fundamentals, Requirements and Practice

I. Introduction

II.Scope and Responsibilities

III. Design and Development Planning

IV. Design Input and Output

V. Design Reviews

VI. Design Verification and Validation

VII. Test Method, Process and Software Validation

VIII. Risk Management

IX. Design Transfer and Process Validation

X. Design History File

XI. Q&A

Alan Golden
Principal
Design Quality Consultants LLC

D Drive Quality and Employee Engagement Through Grateful Leadership and Acknowledgment

Learning Goals:

I. Identify the 7 principles of Acknowledgment

II.Outline the 5cs of Grateful Leadership

III. Discuss How Organizational Performance Is Linked to Leadership and Acknowledgment

IV. Learn about How People in Technical Roles Can Enhance their Leadership Presence and Acknowledge Peers to Improve Dynamics

V. Review Case Studies and Real-Life Examples of the Power of Grateful Leadership and Acknowledgment

VI. Participate in a Knock Your Socks Off Acknowledgment Interactive Exercise

VII. Provide a Path Forward with Tools and Resources to Enhance Your Grateful Leadership Skills

Judy Umlas
Senior Vice President, Author, Trainer
International Institute for Learning, Inc.

10:00

Networking and Refreshment Break for all Workshops

10:30

Workshops Resume

12:00

Close of Workshops and Networking Luncheon

1:00

Identify Key Learnings and Common Roadblocks to Ensure Successful Audits

I. Preparing for a Third-Party Audit or Inspection

II. Conducting the Audit

III. Responding to Audit Findings

Alan Golden
Principal
Design Quality Consultants LLC

2:00

INTERACTIVE DISCUSSION AND Q&AWhat’s Next for Validation and Quality —
Tangible Takeaways, Strategic Insights and Lessons Learned

MODERATOR:

Praveen Kalluri
Director, Quality Assurance – Computer System Validation
PTC Therapeutics

CONVERSATION CONTRIBUTORS:

Chris Wubbolt
Principal
QACV BioPharma Group

Willis Thomas, PhD, PMP, CPT
Editorial Advisory Board Member
Journal of Validation Technology and Journal of GXP Compliance

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, OCTOBER 16, 2019

3nd Annual Women in Validation Empowerment Summit

9:00

Summit Check-In and Welcome Refreshments

9:30

PANEL Paving the Way for Women in Validation and Quality

MODERATOR:

Connie Hetzler
Global Validation Head
Alcon Labs

PANEL:

Lizzandra Rivera
Assistant Director Quality – Systems,
Standards and Compliance, CSV Program Manager
Alexion

Kimberly A. Trautman, MS
Executive Vice President Medical Device International Services
NSF Medical Devices

Michelle Hickey
Director, Validation
Clovis Oncology

10:30

TABLE TALKS

11:30

Close of Summit and Lunch for Summit Participants

11:30

Main Conference Registration

12:30

Conference Chair’s Welcome and Opening Remarks

Praveen Kalluri
Director, Quality Assurance – Computer System Validation
PTC Therapeutics

REGULATORY SHOWCASE Insight from the FDA ORA Medical Devices and Pharmaceuticals — Learn from
Recent Inspections to Increase Efficiencies and Decrease Violations

12:45

FDA ORA Medical Devices Spotlight

Raymond W. Brullo, MD, DPM
Compliance Officer, Office of Medical Devices and Radiological
Health Operations Div. 3, Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration (USFDA) (Invited)

1:30

Explore the Convergence of Global Regulatory Trends Impacting Quality Management

Kimberly A. Trautman, MS
Executive Vice President Medical Device International Services
NSF Medical Devices

2:15

Game Changer! Update on FDA and Industry Collaboration on
Computer Software Assurance (CSA)

MODERATOR:

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

PANELISTS:

Ken Shitamoto
Senior Director, IT
Gilead

Francisco Vicenty
Program Manager, Case for Quality Center for Devices and Radiological Health
U.S. Food and Drug Administration

Shana Kinney
Senior Manager, Computer Systems Validation
REGENXBIO Inc.

Stephen Cook
Senior Quality Manager
Compliance Group

Harsha Chulki
Senior Validation Manager
ICU Medical

3:15

Networking and Refreshment Break

3:45

Cell Therapy Manufacturing Facility Design, Construction and Validation

William Johnson
Director Facilities & Validation
Bellicum Pharmaceuticals

4:30

Advanced Therapy Medicinal Products (ATMPs) —
A Journey into Uncharted Territory

Javier Cardenas, PhD
Senior Consultant
Azzur Group

5:15

Go Lean! Mastering the Principles and Best Practices of Lean Validation

Valarie King-Bailey, MBA
Chief Executive Officer
OnShore Technology Group, Inc.

6:00

IVT Awards Ceremony

6:30

Close of Day One

NETWORKING RECEPTION immediately following the awards ceremony

DAY TWO THURSDAY, OCTOBER 17, 2019

8:00

Continental Breakfast

8:30

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (1-4)

VALIDATION
ESSENTIALS

1 Drive Process Understanding through Optimized Process Validation and Qualification

I. Review How the Product Lifecycle Links with the Most Recent Process Validation Lifecycle as Defined by the Main Regulatory Bodies

II. Demonstrate an Understanding of the Interactions Between Process Understanding and Process Validation

III. Case Study #1 — Process Understanding in a
Bulk Biotech plant leading to a successful Process Validation

IV. Case Study #2 —
How a challenging Process Validation for a Biotechnology Drug Product influenced Process Understanding for subsequent products in the pipeline

V. Interactive Activity

Gerardo Gómez, PhD
Senior Manager Business Development
PharmaLex

QUALITY CONTROL
& COMPLIANCE

2URS & Implementation of Risk-Based Cleaning Validation Management System

Learning Goals:

I. Manual Systems vs. Computerized Systems

II. Benefits of Compliant Computerized Cleaning Validation Software System

III. Components of a Compliant Cleaning Validation System

IV. Cleaning Validation User Requirements Based on Inherent Risks

V. New FDA Draft Guideline “DATA Integrity”

VI. Supplier Qualification

VII. Implementation, Validation and Training

VIII. Q&A

Parsa Famili, MSc
President & CEO
Novatek International

CSV & IT

3 Pragmatic CSV —
Risk-Based Testing and Documentation

I. Background

II. Non-product Computer System Validation (NP CSV)

III. System-level Risk (SLR)

IV. Interactive Exercise

V. Leveraging Software Quality Assurance (SQA)

VI. Next Steps

Ken Shitamoto
Senior Director, IT
Gilead

Senthil Gurumoorthi
Associate Director
Gilead

MANUFACTURING
& PRODUCTION

4 Develop a Strategic Plan for Facilities Design, Qualification and Validation

I. Facilities Validations Overview

II. Types of Facilities Validations

III. Executing and Documenting Facilities Validations

IV. Q&As and Lessons Learned

Mauricio Chinchilla Romero
Senior Quality Engineer
Edwards Lifesciences

10:00

Brief Refreshment Break

10:30

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (5-8)

VALIDATION
ESSENTIALS

5 Develop a Strategic Lifecycle Approach to
Validation and Risk Management

I. Mapping the Lifecycle

II. Risk Identification in the Lifecycle

III. Integrating Your Risk Management Program into a Meaningful Strategy

IV. Interactive Activity

Connie Hetzler
Global Validation Head
Alcon Labs

QUALITY CONTROL
& COMPLIANCE

6 Integrate Quality-by-Design Lifecycle into Process Validation, Qualification and Quality Systems

Learning Goals:

I. Outline, Definitions and Objectives

II. Define QbD and Lifecycle to Process Validation

III. Apply QbD/Lifecycle to Other Pharma Processes

IV. Analyze and Apply QbD/Lifecycle to Equipment and Other Qualification

V. Apply QbD/Lifecycle to Quality System Applications

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT and Informa Connect;
Managing Director, Lifecycle Compliance Systems

CSV & IT

7 Take the Fear Out of Change Control in CSV & IT

Learning Goals:

I. Change Control — Why? Understand Change Control and
How to Ensure the Process Remains in Control

II. Understanding the Differences between Change Classification and Assessments

III. Navigate Application Changes and Security/Patch Updates

IV. Our Change Control vs. their Change Control —
On Prem Systems vs. Cloud Solutions

V. Case Study —
Evaluate Types of Changes One May Encounter and How to Deal with Them

Lizzandra Rivera, AD
Quality – Systems, Standards and Compliance
Alexion Pharmaceuticals

MANUFACTURING
& PRODUCTION

8Mastering Automated Validation Testing —
Principles and Best Practices

Learning Goals:

I. Test Automation Trends

II. Regulatory Considerations

III. IV&V Testing Principles and Best Practices

IV. Considerations for Automation — A Holistic vs. Tool Approach

V. Case Study — Applied Automated Validation Strategies for an ERP Project

Valarie King-Bailey, MBA
Chief Executive Officer
OnShore Technology Group, Inc.

12:00

Networking Luncheon

1:15

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (9-12)

VALIDATION
ESSENTIALS

9 Validation Master Planning — A Risk-Based Approach

I. ICH Q9 and Quality Risk Management and The Risk Priority Number (RPN)

II. FDA’s View of the Importance of Risk Management in GMP Compliance and Validation

III. Applying Risk Management to the Validation Process and Developing a Master Plan

Gamal Amer
Principal
Premier Compliance Services

QUALITY CONTROL
& COMPLIANCE

10 Human Error Reduction in Validation Activities —
A CAPA Approach

The cost of human error to the life sciences industry results in billions of dollars in lost revenue annually, in addition to products and services that never make it to market. Understanding the root causes of mistakes that people make through looking at the human performance model is one of the first steps that must be taken to address investigations and deviations that are associated with validation-related activities.

Interactive Activity

Willis Thomas, PhD, PMP, CPT
Editorial Advisory Board Member
Journal of Validation Technology and Journal of GXP Compliance

CSV & IT

11 Streamlined Integrated IT Governance, to Eliminate Redundancies, Improve Quality, and Enhance Compliance

Stephen Cook
Senior Quality Manager
Compliance Group

Harsha Chulki
Senior Validation Manager
ICU Medical

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

MANUFACTURING
& PRODUCTION

12 Global Problems in Cleaning Validation — 2019

Learning Goals:

I. Outline, Definitions and Objectives

II. Discuss API and Product-Related Problems

III. Describe Equipment-Related Cleaning Problems

IV. Analyze Cleaning Process Problems

V. Discuss and Describe Analytical Laboratory Problems

VI. Management and Staff Problems

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT and Informa Connect;
Managing Director, Lifecycle Compliance Systems

2:45

Networking and Refrshment Break

3:15

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (13-16)

VALIDATION
ESSENTIALS

13 Pragmatic Approaches to Third-Party Risk Management and Validation Oversight

I. What Are Quality Agreements?

II. Developing a Quality Agreement

III. Interactive Exercise

Crystal Booth, M.M.
Regional Manager
PSC Biotech

QUALITY CONTROL
& COMPLIANCE

14 Achieve Outstanding Productivity Results in the
QC Lab with an EVLMS Approach

Practical guide with case studies to implement an efficient and compliant e-validation EVLMS solution for lab asset lifecycle management.

Lou Killian
Director Customer Education & Success
Kneat Software

CSV & IT

15 Bring Your Own Data Integrity Challenge

In recent years, data integrity has become a hot issue for regulators. The number of citations of data integrity lapses has increased worldwide as regulators focus in on this important practice. In this interactive session, attendees are encouraged to submit their own data integrity challenges, real issues they face on a regular basis in their work. Together, we will discuss these challenges and propose solutions that hopefully will help all in the vital effort of increasing data integrity levels in all areas of our profession.

Lizzandra Rivera
Associate Director IT Quality
Alexion

MANUFACTURING
& PRODUCTION

16 Cleanrooms On-Demand, a Paradigm Shift in
Early Phase Bio/Pharmaceutical Manufacturing

With increasing demands for manufacturing space and GMP capabilities, an alternate option to contract manufacturing and/or in-house manufacturing is now available to the bio/pharma and related industries. This talk details this new manufacturing option for pre-clinical or early phase clinical companies. The talk also provides Azzur’s approach to qualification/validation of this new manufacturing option.

Ravi Samavedam
General Manager
Azzur Group

3:00

Networking and Refreshment Break

4:15

CHOOSE BETWEEN FOUR BREAKOUT SESSIONS (17-20)

VALIDATION
ESSENTIALS

17 Maintenance of the Validated State for Commercial Manufacturing Processes

Learning Goals:

I. Review Lifecycle Approach for Process Validation focused on Validation Maintenance and CPV

II. Identify Applicable Global Regulations and Guidance

III. Explore Approaches to Implementation of a Validation Maintenance Program

IV. Identify Best Practices and Challenges

V. Live Benchmarking Poll (results will be compiled and shared with participants)

Michelle Hickey
Director, Validation
Clovis Oncology

QUALITY CONTROL
& COMPLIANCE

18 Develop Effective Tools and Tactics for Audit Preparation

J. Sean Osso
Quality Engineer – Expert
Agilent Technologies

CSV & IT

19 Arrival of a New Era in Validation

Learning Goals:

I. Significance of Data Integrity

II. Risk Evaluation Strategies

III. Compliance Factors for Cloud Validation

IV. Embedded Systems in Equipment Validation

V. Importance of Periodic Reviews

VI. Clear Definition of Roles and Responsibilities

VII. Systems Audit Process

VIII. Interactive Discussion

Praveen Kalluri
Director, Quality Assurance – Computer System Validation
PTC Therapeutics

MANUFACTURING
& PRODUCTION

20 Practical Approaches to Supply Chain Validation
and Verification

I. Supply Chain Management

II. Verification of the Supply Chain

III. Validation of the Supply Chain

IV. The Future

Gamal Amer
Principal
Premier Compliance Services

5:15

Close of Day Two

DAY THREE FRIDAY, OCTOBER 18, 2019

7:30

Continental Breakfast

8:00

CHOOSE BETWEEN FOUR WORKSHOPS (A-D)

A Patient-Focused Statistics in Process Validation — Tips and Techniques for the A Non-Statistician

I. Statistics throughout the Process Validation Lifecycle — Overview

II. Optimal Sampling Plans to Demonstrate Performance in Stage 2 of Process Validation

III. Efficient Sampling Plans for Monitoring in Stage 3 of Process Validation

IV. Common Misconceptions about Statistics

V. The Power of Data Visualization

Katherine Giacoletti, MStat
Partner
SynoloStats LLC

B Leverage Data Integrity Audits to Eliminate 483s and Warning Letter Observations

Learning Goals:

I. Review of Typical Data Integrity Related 483s and Warning Letters

II. Discuss Route Cause of these Observations

III. Incorporating Learnings into Data Integrity Program

IV. Conducting Data Integrity Audits/Assessments

IV. Case Study — Conduct a Laboratory Data Integrity Assessment

Chris Wubbolt
Principal
QACV BioPharma Group

II. Mock Audit

Willis Thomas, PhD, PMP, CPT
Editorial Advisory Board Member
Journal of Validation Technology and Journal of GXP Compliance

C Design Control —
Fundamentals, Requirements and Practice

I. Introduction

II.Scope and Responsibilities

III. Design and Development Planning

IV. Design Input and Output

V. Design Reviews

VI. Design Verification and Validation

VII. Test Method, Process and Software Validation

VIII. Risk Management

IX. Design Transfer and Process Validation

X. Design History File

XI. Q&A

Alan Golden
Principal
Design Quality Consultants LLC

D Drive Quality and Employee Engagement Through Grateful Leadership and Acknowledgment

Learning Goals:

I. Identify the 7 principles of Acknowledgment

II.Outline the 5cs of Grateful Leadership

III. Discuss How Organizational Performance Is Linked to Leadership and Acknowledgment

IV. Learn about How People in Technical Roles Can Enhance their Leadership Presence and Acknowledge Peers to Improve Dynamics

V. Review Case Studies and Real-Life Examples of the Power of Grateful Leadership and Acknowledgment

VI. Participate in a Knock Your Socks Off Acknowledgment Interactive Exercise

VII. Provide a Path Forward with Tools and Resources to Enhance Your Grateful Leadership Skills

Judy Umlas
Senior Vice President, Author, Trainer
International Institute for Learning, Inc.

10:00

Networking and Refreshment Break for all Workshops

10:30

Workshops Resume

12:00

Close of Workshops and Networking Luncheon

1:00

Identify Key Learnings and Common Roadblocks to Ensure Successful Audits

I. Preparing for a Third-Party Audit or Inspection

II. Conducting the Audit

III. Responding to Audit Findings

Alan Golden
Principal
Design Quality Consultants LLC

2:00

INTERACTIVE DISCUSSION AND Q&AWhat’s Next for Validation and Quality —
Tangible Takeaways, Strategic Insights and Lessons Learned

MODERATOR:

Praveen Kalluri
Director, Quality Assurance – Computer System Validation
PTC Therapeutics

CONVERSATION CONTRIBUTORS:

Chris Wubbolt
Principal
QACV BioPharma Group

Willis Thomas, PhD, PMP, CPT
Editorial Advisory Board Member
Journal of Validation Technology and Journal of GXP Compliance

3:00

Close of Conference