Skip navigation
Agenda

Paving the Way to Validation Excellence

October 22-24, 2018
  • San Diego, CA

Agenda

Want more agenda details? Download the brochure.

DAY ONE MONDAY, OCTOBER 22, 2018

2nd Annual Women in Validation Empowerment Summit

9:00

Summit Check-In and Welcome Refreshments

9:30

PANEL Climbing the Career Ladder — Shared Experiences from Women in Life Sciences

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

Roberta Goode, MSBE, CQE
Altrec, LLC

Valarie King-Bailey
Chief Executive Officer
OnShore Technology

10:30

TABLE TALKS

A. Building Leadership Skills Outside of Your Functional Expertise

Janine Hanson
Head of Q&R Software Management, Senior Director
Philips

B. The Importance of Having a Mentor and a Sponsor to Further Your Career

Delores Morrison
Engineering Director, Global Validation
Edwards Life Sciences

C. Strategies for Getting the Salary You Deserve

Roberta Goode, MSBE, CQE
Altrec, LLC

D. Managing Conflict in the Workplace

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

E. Setting Your Sights on the Top —
How to Advance a Late-Stage Career to a High-Level Position

Valarie King-Bailey
Chief Executive Officer
OnShore Technology

F. Achieving a Fulfilling Work/Life Balance

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

Please Note: All are welcome to attend the Women in Validation Empowerment Summit.
If you would like to attend, you must select the pre-conference summit in your registration.

11:30

Main Conference Registration

12:30

Chairperson’s Welcome and Opening Remarks

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

U.S. FDA REGULATORY SHOWCASE Insight From the FDA Office of Regulatory Affairs — Learn from Recent
Inspections to Increase Efficiencies and Decrease Violations

12:45

Part 1: FDA ORA Medical Devices

Raymond Brullo, DPM
Compliance Officer, Office of Regulatory Affairs
U.S. Food and Drug Administration

1:30

Part 2: FDA ORA Pharmaceuticals

Linda Thai
Consumer Safety Officer, Office of Regulatory Affairs
U.S. Food and Drug Administration

2:15

Mastering EU GDPR Compliance — Security and Privacy for Validated Systems

Valarie King-Bailey
Chief Executive Officer
OnShore Technology

3:00

Networking and Refreshment Break

3:30

Adapt “Current” GMP to Innovative Technologies — A Challenge for Regulators

David L. Chesney
Principal and General Manager
DL Chesney Consulting, LLC

4:15

Cross-Functional Collaboration Excellence — Enhance Alliance and Inter-Departmental Functionality between Validation, Quality, IT and Engineering

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

5:00

Fireside Chat — Innovations in Validation Systems and Quality Culture

DISCUSSION LEADER:

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

EXPERT:

Michael Loiterman
U.S. Head of Regulatory Affairs, Quality Assurance & Quality Control
Richard Wolf Medical Instruments

5:45

IVT Awards Ceremony

6:00

NETWORKING RECEPTION immediately following the awards ceremony

DAY TWO TUESDAY, OCTOBER 23, 2018

7:30

Continental Breakfast

8:00

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (1-4)

GENERAL

1 Standardize Your Validation Process Based on Product, Process and Configuration

I. Define Your Process Validation

II. Standardization of the Process Validation

Jorge A. Cordero, BSChE, MBA-GM
Principal Validation Engineer
Bausch + Lomb

MEDICAL DEVICE

2 Harmonize Growing Global Companies —
Strategies for Integrating Quality Systems in M&A

The life sciences industry is experiencing a surge in mergers and acquisitions. Combining cultures and policies is never simple, but in the case of aligning quality systems, it is essential to plan for integration. In this interactive session, explore strategies for riskbased integration of the key elements of quality systems, including risk management, post-market surveillance, supplier quality, CAPA and remediation of legacy documentation. The session concludes with a case study on the integration of quality systems due to M&A in the medical device manufacturing industry.

Roberta Goode, MSBE, CQE
Altrec, LLC

PHARMA

3 Data Integrity and Validation Oversight Strategy in a Virtual Pharmaceutical Company

Data integrity has recently become a major focus by regulatory authorities. Industry is dedicating significant resources to establish data integrity programs, provide data integrity training and conduct assessments. More and more companies, particularly smaller virtual companies, are outsourcing their clinical research and manufacturing operations. Therefore, validation controls are being transferred from the pharmaceutical company to outsourced third parties, but the integrity of the data is still the responsibility of the pharmaceutical company. This presentation discusses the governance programs and controls that should be considered to ensure the integrity of data for a virtual pharmaceutical company.

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

PHARMA

4 Implement Continued Process Verification —
Insights on Managing Control Charts

The 2011 FDA Guidance on Process Validation requires pharmaceutical manufacturers to demonstrate that their validated processes continue to remain in a validated state throughout the lifecycle of the drug product. Further, there is greater emphasis on the use of statistical methods to support this. Control charts are a useful tool to monitor process data to show that the process remains stable and in a state of statistical control. They also help identify when process improvements are necessary to continue to remain in a validated state and/or meet customer requirements.

This session focuses on the use of control charts in the pharmaceutical industry and provides insights for their implementation.

Maneesha Altekar
Senior Technical Manager
AstraZeneca

8:45

Brief Refreshment Break

9:00

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (5-8)

PHARMA

5 Preparing an Effective Qualification (Validation) Master Plan

I. Process Validation and the Need for Qualification

II. How to Prepare an Effective Qualification Master Plan

III. Interactive Exercise

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

PHARMA

6 Explore the Importance of ICH Guidelines and a Lifecycle Approach in Developing and Implementing
a Quality System

I. ICH Quality Guidances

II. The Lifecycle Approach — Buzzword or Management Tool?

III. Interactive Exercise

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

GENERAL

7 Bulletproofing Your CSV Program — Where to Start and How to Build for Success

I. CSV Is an Important Business Concern — Where Are We Today?

II. Partnering with Your Stakeholders

III. Build Your CSV Program

IV. It Is All About Managing Risk

V. Interactive Exercise IQ-OQ-PQ Game

Janine Hanson
Head of Q&R Software Management, Senior Director
Philips

GENERAL

8 The Art of Technology Transfer —
Execute Cleaning Validations and Assessments for New Facilities and Equipment

I. A Risk-Based Approach for Relocation of Cleaning Processes of Multi-Product to a New Facility

II. Develop a New Cleaning Process

III. Verify and Relocate As-Is Cleaning Process

IV. How to Create a Routine Monitoring Program

Speaker TBA

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (9-12)

GENERAL

9 Practical Guide to Implement a Simplified and Automated Risk-Based Validation Qualification Process

I. Understand the Approach and Benefits of the Simplified Validation Qualification Process

II. BioPharma Tier 1 User Validation Case Study

III. Tangible Takeaways

IV. Interactive Exercise

Lou Killian
Director, Customer Education and Success
Kneat Software

GENERAL

10 CASE STUDY Back to Basics — Streamline IQ, OQ, PQ Processes

I. Develop a Field Guide for Understanding IQ, OQ, PQ

II. Optimize the Program but Stick to the Basics

III. Case Study

Rod Freeman, BS, MS
Global Process Owner, Process Validation
Beckman Coulter

GENERAL

11 Managing Computer Systems Validation in an Agile World

I. Begin with Validation in Mind

II. First Interactive Requirements Agile Style

III. Communicating Requirements

IV. Interactive Exercise — Model the Elevator Problem using Agile Techniques

Brent Gendleman
Innovation and Technology Adoption
Azzur Group

Doug Shaw
Director, CSV & IT Consulting
Azzur Group

GENERAL

12 Senior-Level Think Tank — Gain Solutions to Your Most Complex Validation Hurdles

This session convenes senior-level and experienced validation and quality professionals to discuss problems in various areas of validation and qualification. Specific content is driven by participants, who are surveyed in advance of the session. This session is limited to the first 15 registrants. Participants should have at least 5 years of pharmaceutical or medical device validation experience to register for this session. IVT reserves the right to qualify participants for this session.

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT Network/UBM Americas

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (13-16)

PHARMA

13 Stage 3 in Process Validation —
How to Maintain the Validated State

I. Process Validation and the Validation Lifecycle

II. How to Ensure the Validated State Is Maintained

III. The Importance of Change Control and Post-Change Monitoring

IV. Interactive Exercise

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

GENERAL

14 Risk Part I — Evaluate Different Types of Risk Assessments to Perform the Job

I. What Is a Risk Assessment

II. Types of Risk Assessments

III. Interactive Exercise — Create a Risk Assessment

IV. What to Do With the Results

Joe Cagnassola
Principal Validation Engineer
Novartis

GENERAL

15 CASE STUDY Implement Essential Practices to Transition to an Electronic Validation System

I. Prepare Your Company for the Transition

II. Make the Transition Successful

III. Case Study

IV. Interactive Exercise

Steve Thompson
Senior Manager, Professional Services
ValGenesis, Inc.

Laurent Saugrin
Computer Validation Specialist IV, IT Compliance
Dexcom

PHARMA

16 Recent Changes in GMPs, Focus on EU Annex 1 and How the Validation of Cleanrooms Is Evolving

I. GMP Scan — A Rapid Update on a Lot of Activity

II. EU Annex 1 — Sterile Products, Aseptic Processing, Aseptic Preparation

III. Interactive Exercise

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel

3:00

Networking and Refreshment Break

3:30

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (17-20)

MEDICAL DEVICE

17 CASE STUDY Optimize Cost Reduction in Process Validation Using a Risk-Based Approach

I. Make a Case for a Risk-Based Approach

II. Performing a Risk-Based Approach during PPQ

III. Conclusion

Jorge A. Cordero, BSChE, MBA-GM
Principal Validation Engineer
Bausch + Lomb

GENERAL

18 Risk Part II —
Practical Application of Risk Management Tools to Develop Effective Process Validation

I. The End Game — Process Control

II. Back to the Beginning — Design Control

III. Putting It All Together

IV. Interactive Exercise

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

GENERAL

19 CASE STUDY Establish a Global Change Control Process

I. Out with the Old...

II. ...And In with the New

III. Interactive Exercise — Let’s Go Global!

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

GENERAL

20 Navigate USP <1058> and GAMP 5 —
The Differences and Similarities

I. Review of 2017 USP <1058>

II. Review of GAMP 5

III. USP <1058> and GAMP 5 — Comparison

IV. Interactive Exercise

Michael C. Korbel, BS Biology
Senior Compliance Consultant
Agilent Technologies Inc.

5:00

Close of Day Two

DAY THREE WEDNESDAY, OCTOBER 24, 2018

7:30

Continental Breakfast

8:00

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (21-24)

MEDICAL DEVICE

21 CASE STUDY Build a Strategic Plan for Facilities Validation

I. Facilities Validations Overview

II. Types of Facilities Validations

III. Executing and Documenting Facilities Validations

IV. Q&A and Lessons Learned

Speaker TBA

GENERAL

22 From the Trenches — How to Develop a Transfer Plan for a Site Move and Lessons Learned from Managing Validation Processes During an Acquisition

I. Regulations and Standards and Their Expectations

II. Validation Procedures and Methodologies of the Manufacturing Sites

III. Risk Assessments of the Equipment and Processes before Transfer

IV. Equipment Qualification and Process Validation Review

V. Transfer and Validation Plans

VI. Interactive Exercise

J. Sean Osso
Consulting Engineer/Quality Engineer
Osso2 Consulting Group and TMJ Concepts

GENERAL

23 Ditch the Document —
Using a Data-Centric Approach to CSV to Improve Efficiency and Facilitate a Move to Agile

I. The Paradigm Shift from Documents to Data

II. Agile Transformation

III. Return on Investment

Jason Tepfenhardt
Co-Founder and Managing Partner
Tx3 Services LLC

GENERAL

24 Cutting Costs While Improving Quality in Validation Using Robotic Process Automation (RPA)

I. Introduction to Robotic Process Automation (RPA)

II. Automated Software Testing Using RPA Tools

III. Accelerating and Error-Proofing Repetitive Tasks Using RPA Tools

IV. Using RPA in a Regulated Environment

V. Interactive Exercise

Raymond McKinney, BEng, MBA
Director
NNIT Inc.

9:00

Brief Refreshment Break

9:15

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (25-28)

MEDICAL DEVICE

25 Implement a Successful Test Method Validation (TMV) Program

I. TMV Overview

II. Plan and Execute TMV

III. Interactive Exercise — Case Study

Speaker TBA

MEDICAL DEVICE

26 Statistics for the Non-Statistician Part 1 —
Prepare Statistical Sampling Plans and Integrate Hypothesis Testing

The practical and compliant use of statistical techniques in validation and verification is among the leading challenges cited by life sciences professionals. What sample sizes are adequate? How do we incorporate risk into validation practices? What are auditors looking for? In this interactive session, explore strategies for risk-based selection of sampling plans for verification and validation, including attributes and variables sampling, reliability estimates and balancing consumer and producer risk.

Roberta Goode, MSBE, CQE
Altrec, LLC

GENERAL

27 Bring Your Own CSV Challenge Workshop

During this unique workshop, CSV professionals share their greatest pain points and then collaborate with peers to develop strategies for managing their most pressing challenges. The content for the workshop is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

We encourage you to bring any unique challenges you are currently facing to be worked through during this real-life, discussion-driven session to brainstorm take-home solutions.

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

MEDICAL DEVICE

28 PQ Forum —
Problems in Process Validation Documentation

I. Outline, Definitions and Objectives

II. Stage 1 — Design/Development Document Problems

III. Stage 2 — Demonstration of Document Problems

IV. Stage 3 — Continued Process Verification Document Problems

V. Program Implementation

VI. Technical Writing and Self-Audit Questions

VII. Interactive Exercise

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT Network/UBM Americas

10:45

Networking and Refreshment Break

11:15

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (29-32)

GENERAL

29 Use a Lifecycle Approach to Equipment, Facilities and Utilities Validation

I. Equipment Qualification Requirements

II. Qualification Plan, Protocols and Reports

III. Execution of the Qualification Effort

IV. What to Do with Requalification

Jeff Hanson
Manager, Validation
Upsher-Smith

MEDICAL DEVICE

30 Statistics for the Non-Statistician Part 2 —
Process Characterization in Validation

The key to effective validation is thorough characterization of the manufacturing process during operational qualification. In Part 2 of the statistics workshop, learn the Taguchi fractional factorial technique for experimental design, and master the art and science of factor interactions, screening studies and hypothesis testing that fully meet the requirements of 21 CFR 820 Subpart O Statistical Techniques.

Roberta Goode, MSBE, CQE
Altrec, LLC

GENERAL

31 Establish a Site-Wide or Enterprise-Wide Data Governance Program to Ensure Your Data Integrity

I. Data Governance Programs

II. Implement Data Governance Programs

III. Interactive Exercise

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

GENERAL

32 Understand the Value of a Validation Center of Excellence and Build a Business Case for Your Organization

I. What Is a Center of Excellence (CoE) and Associated Value Proposition?

II. How to Build a Business Case for a Validation CoE

III. Validation CoE Organizational Considerations

IV. Interactive Exercise

Delores Morrison
Engineering Director, Global Validation
Edwards Life Sciences

12:30

Networking Luncheon & Vendor Prize Drawing

1:30

FDA Center for Devices and Radiological Health (CDRH) Address —
Understand How the Regulator and Industry Can Collaborate More Effectively

Francisco Vicenty
Program Manager, Case for Quality, CDRH
U.S. Food and Drug Administration (invited)

2:15

Journey Reflections — Share Challenges and Answer Final Questions

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

2:45

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE MONDAY, OCTOBER 22, 2018

2nd Annual Women in Validation Empowerment Summit

9:00

Summit Check-In and Welcome Refreshments

9:30

PANEL Climbing the Career Ladder — Shared Experiences from Women in Life Sciences

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

Roberta Goode, MSBE, CQE
Altrec, LLC

Valarie King-Bailey
Chief Executive Officer
OnShore Technology

10:30

TABLE TALKS

A. Building Leadership Skills Outside of Your Functional Expertise

Janine Hanson
Head of Q&R Software Management, Senior Director
Philips

B. The Importance of Having a Mentor and a Sponsor to Further Your Career

Delores Morrison
Engineering Director, Global Validation
Edwards Life Sciences

C. Strategies for Getting the Salary You Deserve

Roberta Goode, MSBE, CQE
Altrec, LLC

D. Managing Conflict in the Workplace

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

E. Setting Your Sights on the Top —
How to Advance a Late-Stage Career to a High-Level Position

Valarie King-Bailey
Chief Executive Officer
OnShore Technology

F. Achieving a Fulfilling Work/Life Balance

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

Please Note: All are welcome to attend the Women in Validation Empowerment Summit.
If you would like to attend, you must select the pre-conference summit in your registration.

11:30

Main Conference Registration

12:30

Chairperson’s Welcome and Opening Remarks

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

U.S. FDA REGULATORY SHOWCASE Insight From the FDA Office of Regulatory Affairs — Learn from Recent
Inspections to Increase Efficiencies and Decrease Violations

12:45

Part 1: FDA ORA Medical Devices

Raymond Brullo, DPM
Compliance Officer, Office of Regulatory Affairs
U.S. Food and Drug Administration

1:30

Part 2: FDA ORA Pharmaceuticals

Linda Thai
Consumer Safety Officer, Office of Regulatory Affairs
U.S. Food and Drug Administration

2:15

Mastering EU GDPR Compliance — Security and Privacy for Validated Systems

Valarie King-Bailey
Chief Executive Officer
OnShore Technology

3:00

Networking and Refreshment Break

3:30

Adapt “Current” GMP to Innovative Technologies — A Challenge for Regulators

David L. Chesney
Principal and General Manager
DL Chesney Consulting, LLC

4:15

Cross-Functional Collaboration Excellence — Enhance Alliance and Inter-Departmental Functionality between Validation, Quality, IT and Engineering

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

5:00

Fireside Chat — Innovations in Validation Systems and Quality Culture

DISCUSSION LEADER:

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

EXPERT:

Michael Loiterman
U.S. Head of Regulatory Affairs, Quality Assurance & Quality Control
Richard Wolf Medical Instruments

5:45

IVT Awards Ceremony

6:00

NETWORKING RECEPTION immediately following the awards ceremony

DAY TWO TUESDAY, OCTOBER 23, 2018

7:30

Continental Breakfast

8:00

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (1-4)

GENERAL

1 Standardize Your Validation Process Based on Product, Process and Configuration

I. Define Your Process Validation

II. Standardization of the Process Validation

Jorge A. Cordero, BSChE, MBA-GM
Principal Validation Engineer
Bausch + Lomb

MEDICAL DEVICE

2 Harmonize Growing Global Companies —
Strategies for Integrating Quality Systems in M&A

The life sciences industry is experiencing a surge in mergers and acquisitions. Combining cultures and policies is never simple, but in the case of aligning quality systems, it is essential to plan for integration. In this interactive session, explore strategies for riskbased integration of the key elements of quality systems, including risk management, post-market surveillance, supplier quality, CAPA and remediation of legacy documentation. The session concludes with a case study on the integration of quality systems due to M&A in the medical device manufacturing industry.

Roberta Goode, MSBE, CQE
Altrec, LLC

PHARMA

3 Data Integrity and Validation Oversight Strategy in a Virtual Pharmaceutical Company

Data integrity has recently become a major focus by regulatory authorities. Industry is dedicating significant resources to establish data integrity programs, provide data integrity training and conduct assessments. More and more companies, particularly smaller virtual companies, are outsourcing their clinical research and manufacturing operations. Therefore, validation controls are being transferred from the pharmaceutical company to outsourced third parties, but the integrity of the data is still the responsibility of the pharmaceutical company. This presentation discusses the governance programs and controls that should be considered to ensure the integrity of data for a virtual pharmaceutical company.

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

PHARMA

4 Implement Continued Process Verification —
Insights on Managing Control Charts

The 2011 FDA Guidance on Process Validation requires pharmaceutical manufacturers to demonstrate that their validated processes continue to remain in a validated state throughout the lifecycle of the drug product. Further, there is greater emphasis on the use of statistical methods to support this. Control charts are a useful tool to monitor process data to show that the process remains stable and in a state of statistical control. They also help identify when process improvements are necessary to continue to remain in a validated state and/or meet customer requirements.

This session focuses on the use of control charts in the pharmaceutical industry and provides insights for their implementation.

Maneesha Altekar
Senior Technical Manager
AstraZeneca

8:45

Brief Refreshment Break

9:00

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (5-8)

PHARMA

5 Preparing an Effective Qualification (Validation) Master Plan

I. Process Validation and the Need for Qualification

II. How to Prepare an Effective Qualification Master Plan

III. Interactive Exercise

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

PHARMA

6 Explore the Importance of ICH Guidelines and a Lifecycle Approach in Developing and Implementing
a Quality System

I. ICH Quality Guidances

II. The Lifecycle Approach — Buzzword or Management Tool?

III. Interactive Exercise

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

GENERAL

7 Bulletproofing Your CSV Program — Where to Start and How to Build for Success

I. CSV Is an Important Business Concern — Where Are We Today?

II. Partnering with Your Stakeholders

III. Build Your CSV Program

IV. It Is All About Managing Risk

V. Interactive Exercise IQ-OQ-PQ Game

Janine Hanson
Head of Q&R Software Management, Senior Director
Philips

GENERAL

8 The Art of Technology Transfer —
Execute Cleaning Validations and Assessments for New Facilities and Equipment

I. A Risk-Based Approach for Relocation of Cleaning Processes of Multi-Product to a New Facility

II. Develop a New Cleaning Process

III. Verify and Relocate As-Is Cleaning Process

IV. How to Create a Routine Monitoring Program

Speaker TBA

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (9-12)

GENERAL

9 Practical Guide to Implement a Simplified and Automated Risk-Based Validation Qualification Process

I. Understand the Approach and Benefits of the Simplified Validation Qualification Process

II. BioPharma Tier 1 User Validation Case Study

III. Tangible Takeaways

IV. Interactive Exercise

Lou Killian
Director, Customer Education and Success
Kneat Software

GENERAL

10 CASE STUDY Back to Basics — Streamline IQ, OQ, PQ Processes

I. Develop a Field Guide for Understanding IQ, OQ, PQ

II. Optimize the Program but Stick to the Basics

III. Case Study

Rod Freeman, BS, MS
Global Process Owner, Process Validation
Beckman Coulter

GENERAL

11 Managing Computer Systems Validation in an Agile World

I. Begin with Validation in Mind

II. First Interactive Requirements Agile Style

III. Communicating Requirements

IV. Interactive Exercise — Model the Elevator Problem using Agile Techniques

Brent Gendleman
Innovation and Technology Adoption
Azzur Group

Doug Shaw
Director, CSV & IT Consulting
Azzur Group

GENERAL

12 Senior-Level Think Tank — Gain Solutions to Your Most Complex Validation Hurdles

This session convenes senior-level and experienced validation and quality professionals to discuss problems in various areas of validation and qualification. Specific content is driven by participants, who are surveyed in advance of the session. This session is limited to the first 15 registrants. Participants should have at least 5 years of pharmaceutical or medical device validation experience to register for this session. IVT reserves the right to qualify participants for this session.

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT Network/UBM Americas

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (13-16)

PHARMA

13 Stage 3 in Process Validation —
How to Maintain the Validated State

I. Process Validation and the Validation Lifecycle

II. How to Ensure the Validated State Is Maintained

III. The Importance of Change Control and Post-Change Monitoring

IV. Interactive Exercise

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

GENERAL

14 Risk Part I — Evaluate Different Types of Risk Assessments to Perform the Job

I. What Is a Risk Assessment

II. Types of Risk Assessments

III. Interactive Exercise — Create a Risk Assessment

IV. What to Do With the Results

Joe Cagnassola
Principal Validation Engineer
Novartis

GENERAL

15 CASE STUDY Implement Essential Practices to Transition to an Electronic Validation System

I. Prepare Your Company for the Transition

II. Make the Transition Successful

III. Case Study

IV. Interactive Exercise

Steve Thompson
Senior Manager, Professional Services
ValGenesis, Inc.

Laurent Saugrin
Computer Validation Specialist IV, IT Compliance
Dexcom

PHARMA

16 Recent Changes in GMPs, Focus on EU Annex 1 and How the Validation of Cleanrooms Is Evolving

I. GMP Scan — A Rapid Update on a Lot of Activity

II. EU Annex 1 — Sterile Products, Aseptic Processing, Aseptic Preparation

III. Interactive Exercise

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel

3:00

Networking and Refreshment Break

3:30

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (17-20)

MEDICAL DEVICE

17 CASE STUDY Optimize Cost Reduction in Process Validation Using a Risk-Based Approach

I. Make a Case for a Risk-Based Approach

II. Performing a Risk-Based Approach during PPQ

III. Conclusion

Jorge A. Cordero, BSChE, MBA-GM
Principal Validation Engineer
Bausch + Lomb

GENERAL

18 Risk Part II —
Practical Application of Risk Management Tools to Develop Effective Process Validation

I. The End Game — Process Control

II. Back to the Beginning — Design Control

III. Putting It All Together

IV. Interactive Exercise

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

GENERAL

19 CASE STUDY Establish a Global Change Control Process

I. Out with the Old...

II. ...And In with the New

III. Interactive Exercise — Let’s Go Global!

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

GENERAL

20 Navigate USP <1058> and GAMP 5 —
The Differences and Similarities

I. Review of 2017 USP <1058>

II. Review of GAMP 5

III. USP <1058> and GAMP 5 — Comparison

IV. Interactive Exercise

Michael C. Korbel, BS Biology
Senior Compliance Consultant
Agilent Technologies Inc.

5:00

Close of Day Two

DAY THREE WEDNESDAY, OCTOBER 24, 2018

7:30

Continental Breakfast

8:00

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (21-24)

MEDICAL DEVICE

21 CASE STUDY Build a Strategic Plan for Facilities Validation

I. Facilities Validations Overview

II. Types of Facilities Validations

III. Executing and Documenting Facilities Validations

IV. Q&A and Lessons Learned

Speaker TBA

GENERAL

22 From the Trenches — How to Develop a Transfer Plan for a Site Move and Lessons Learned from Managing Validation Processes During an Acquisition

I. Regulations and Standards and Their Expectations

II. Validation Procedures and Methodologies of the Manufacturing Sites

III. Risk Assessments of the Equipment and Processes before Transfer

IV. Equipment Qualification and Process Validation Review

V. Transfer and Validation Plans

VI. Interactive Exercise

J. Sean Osso
Consulting Engineer/Quality Engineer
Osso2 Consulting Group and TMJ Concepts

GENERAL

23 Ditch the Document —
Using a Data-Centric Approach to CSV to Improve Efficiency and Facilitate a Move to Agile

I. The Paradigm Shift from Documents to Data

II. Agile Transformation

III. Return on Investment

Jason Tepfenhardt
Co-Founder and Managing Partner
Tx3 Services LLC

GENERAL

24 Cutting Costs While Improving Quality in Validation Using Robotic Process Automation (RPA)

I. Introduction to Robotic Process Automation (RPA)

II. Automated Software Testing Using RPA Tools

III. Accelerating and Error-Proofing Repetitive Tasks Using RPA Tools

IV. Using RPA in a Regulated Environment

V. Interactive Exercise

Raymond McKinney, BEng, MBA
Director
NNIT Inc.

9:00

Brief Refreshment Break

9:15

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (25-28)

MEDICAL DEVICE

25 Implement a Successful Test Method Validation (TMV) Program

I. TMV Overview

II. Plan and Execute TMV

III. Interactive Exercise — Case Study

Speaker TBA

MEDICAL DEVICE

26 Statistics for the Non-Statistician Part 1 —
Prepare Statistical Sampling Plans and Integrate Hypothesis Testing

The practical and compliant use of statistical techniques in validation and verification is among the leading challenges cited by life sciences professionals. What sample sizes are adequate? How do we incorporate risk into validation practices? What are auditors looking for? In this interactive session, explore strategies for risk-based selection of sampling plans for verification and validation, including attributes and variables sampling, reliability estimates and balancing consumer and producer risk.

Roberta Goode, MSBE, CQE
Altrec, LLC

GENERAL

27 Bring Your Own CSV Challenge Workshop

During this unique workshop, CSV professionals share their greatest pain points and then collaborate with peers to develop strategies for managing their most pressing challenges. The content for the workshop is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

We encourage you to bring any unique challenges you are currently facing to be worked through during this real-life, discussion-driven session to brainstorm take-home solutions.

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

MEDICAL DEVICE

28 PQ Forum —
Problems in Process Validation Documentation

I. Outline, Definitions and Objectives

II. Stage 1 — Design/Development Document Problems

III. Stage 2 — Demonstration of Document Problems

IV. Stage 3 — Continued Process Verification Document Problems

V. Program Implementation

VI. Technical Writing and Self-Audit Questions

VII. Interactive Exercise

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT Network/UBM Americas

10:45

Networking and Refreshment Break

11:15

CHOOSE BETWEEN FOUR EDUCATIONAL BREAKOUT SESSIONS (29-32)

GENERAL

29 Use a Lifecycle Approach to Equipment, Facilities and Utilities Validation

I. Equipment Qualification Requirements

II. Qualification Plan, Protocols and Reports

III. Execution of the Qualification Effort

IV. What to Do with Requalification

Jeff Hanson
Manager, Validation
Upsher-Smith

MEDICAL DEVICE

30 Statistics for the Non-Statistician Part 2 —
Process Characterization in Validation

The key to effective validation is thorough characterization of the manufacturing process during operational qualification. In Part 2 of the statistics workshop, learn the Taguchi fractional factorial technique for experimental design, and master the art and science of factor interactions, screening studies and hypothesis testing that fully meet the requirements of 21 CFR 820 Subpart O Statistical Techniques.

Roberta Goode, MSBE, CQE
Altrec, LLC

GENERAL

31 Establish a Site-Wide or Enterprise-Wide Data Governance Program to Ensure Your Data Integrity

I. Data Governance Programs

II. Implement Data Governance Programs

III. Interactive Exercise

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

GENERAL

32 Understand the Value of a Validation Center of Excellence and Build a Business Case for Your Organization

I. What Is a Center of Excellence (CoE) and Associated Value Proposition?

II. How to Build a Business Case for a Validation CoE

III. Validation CoE Organizational Considerations

IV. Interactive Exercise

Delores Morrison
Engineering Director, Global Validation
Edwards Life Sciences

12:30

Networking Luncheon & Vendor Prize Drawing

1:30

FDA Center for Devices and Radiological Health (CDRH) Address —
Understand How the Regulator and Industry Can Collaborate More Effectively

Francisco Vicenty
Program Manager, Case for Quality, CDRH
U.S. Food and Drug Administration (invited)

2:15

Journey Reflections — Share Challenges and Answer Final Questions

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

2:45

Close of Conference