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Agenda

A World of Validation Knowledge — Embark on the Journey to Compliance in a Complex and Highly-Regulated Environment

March 13-15, 2018
  • Brussels, Belgium

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY 13 MARCH 2018

12:15

Main Conference Registration

13:15

Chairman’s Welcome and Opening Remarks

Willis H. Thomas, PhD, PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

13:30

KEYNOTE ADDRESS Regulatory Pulse on Emerging Enforcement Trends and Recent Warning Letters

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

14:15

Performing an Impact Assessment to Support Quality Risk Management

Willis H. Thomas, PhD, PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

15:00

Networking and Refreshment Break

15:30

DATA INTEGRITY SPOTLIGHTA New Wave of Risk — Proactive Strategies for the Prevention and
Remediation of Data Integrity Non-Compliance

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

16:15

Presentation of IVT’s 2017 Ken Chapman Award

16:20

Remembering Ken Chapman — Points to Consider for 3-Stage PV

Cliff Campbell, BE
Principal
Cliff Campbell Consulting Ltd.

17:00

Close of Day One

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

DAY TWO WEDNESDAY 14 MARCH 2018

7:30 EYE-OPENING BREAKFAST DISCUSSION
Serialisation — How are we doing? Sharing Lessons Learned for Continuous Improvement

Willis H. Thomas, PhD, PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

8:30–10:00

CHOOSE FROM THREE 90-MINUTE SESSIONS (1-3)

SESSION 1Validation Documentation—Initiation, Plan, Protocol and Results

I. Validation Documents Overview, Approach, Hierarchy and Contents

II. Lifecycle Approach to Process Validation

III. Validation Initiation

IV. Validation Plan

V. Validation Protocol

VI. Validation Results

VII. Miscellaneous Documentation Topics

VIII. Interactions — Throughout Discussion

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology
and Journal of GXP Compliance IVT/CBI/UBM
;
Associate Professor, Biopharmaceutics,
University of Illinois at Chicago (UIC) College of Pharmacy

SESSION 2Introduction to Statistics in Validation for the Non-Statisticians

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

SESSION 3Equipment Qualification — Ensure Fit for Intended Use

I. Types of Qualification

II. Validating Equipment — Keeping it Simple

III. Interactive Exercise

Mary Sexton
B.Eng, Production Validation Engineer
Servier

10:00 Networking and Refreshment Break

10:30–12:00

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

SESSION 5Validation Master Plan Development

I. Overview

II. Validation Master Plan — Site Document

III. Validation Master Plan — Function Document

IV. Validation Master Plan — Major Project

V. Validation Project Plan — All Validation and Qualification

VI. Miscellaneous Topics

VII. Interactive Discussion

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology
and Journal of GXP Compliance IVT/CBI/UBM
;
Associate Professor, Biopharmaceutics,
University of Illinois at Chicago (UIC) College of Pharmacy

SESSION 6Acceptance Criteria for Validations

I. What are Acceptance Criteria?

II. How to Think about Acceptance Criteria in Process and Test
Method Validation

III. Setting Acceptance Criteria to Meet the Needs of the Product
and/or Process

IV. Risk-Based Decisions

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

12:00 Networking Luncheon

13:00–14:30

CHOOSE FROM THREE 90-MINUTE SESSIONS (7-9)

SESSION 7Align Validation with FDA’s Quality Metrics Guidance — What You Need to Know

I. Regulations, Guidance and Current Inspectional Issues

II. Developing Metrics for Validation

III. Interactive Exercise

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

SESSION 8Integration of Risk into Change Control

I. Review of Change Control

II. Evaluate Change Control Systems

III. Develop a Consistent and Direct Method to Assess Impact of Changes

IV. Implementation of Change

V. Interactive Exercise

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

SESSION 9Proper Audit Planning to Ensure Maximum Effectiveness and Efficiency

I. Interactive Discussion — What Constitutes a Successful Audit?

II. Audit Schedules

III. Audit Planning

IV. Audit Conduct

V. Audit Reporting

VI. Follow-Up Processes

Chris Wubbolt
Principal
QACV Consulting

14:30

Networking and Refreshment Break

15:00–16:30

CHOOSE FROM THREE 90-MINUTE SESSIONS (10-12)

SESSION 10Understand, Detect and Control Variation NEW: ICH Q12 Draft, USP <1220>

I. Understanding Variation

II. Reducing and Controlling Variation

III. Interactive Exercise

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

SESSION 11Global Problems in Cleaning and Cleaning Validation—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. Self-Audit Questions

VIII. Interactive Discussion During Presentation

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology
and Journal of GXP Compliance IVT/CBI/UBM
;
Associate Professor, Biopharmaceutics,
University of Illinois at Chicago (UIC) College of Pharmacy

SESSION 12Manufacturing Execution Systems

I. Introduction

II. MES Operation

III. Benefits of MES

Mary Sexton
B.Eng, Production Validation Engineer
Servier

16:30

Close of Day Two

DAY THREE THURSDAY 15 MARCH 2018

8:00

Continental Breakfast

8:30

Validation Efficiency Improvements and Cost Reduction

I. Challenges in Validation that Impact Efficiency and Cost

II. Cost Effective Streamlined Efficient Strategies

III. Innovative Approach that Enable Efficiency and Cost Reduction

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

10:00

Networking and Refreshment Break

10:30–12:00

CHOOSE BETWEEN TWO IN-DEPTH WORKSHOPS (II-III)

WORKSHOP II: Develop and Implement Risk-Based Approaches
for Data Integrity

I. Examples of Data Integrity Issues

II. Measures to Detect Data Integrity Issues

III. Interactive Exercise

Workshop Leader:

Chris Wubbolt
Principal
QACV Consulting

WORKSHOP III: An Innovative Approach to C&Q — Practical Guide to Establish a Simplified and Automated Risk-Based Commissioning and Qualification (C&Q) Process

I. Discussion of Improved C&Q Business Process

II. BioPharma User Case Study Reporting Use of Improved C&Q Process

III. Review of Automated C&Q Process with Q&A

Workshop Leaders:

Lou Killian
Director Customer Success
Kneat Solutions Inc.

Rick Mineo
Founder and President
Encova Consulting

12:00

Networking Luncheon and Vendor Prize Card Drawing

13:00–14:30

CHOOSE BETWEEN TWO 90-MINUTE SUMMITS (A-B)

SUMMIT APurified Water Design

I. Introduction

II. Typical Purified Water System Design

III. Routine Operation

Mary Sexton
B.Eng, Production Validation Engineer
Servier

SUMMIT B Think Tank on Criticality as a Continuum

Cliff Campbell, BE
Principal
Cliff Campbell Consulting Ltd.

14:30

Networking Luncheon

15:00–16:30

CHOOSE BETWEEN TWO 90-MINUTE SUMMITS (C-D)

SUMMIT C Safeguard Data — Risk-Based Cyber Security

I. Risk Assessment — Vulnerability

II. Information Security

III. Environmental Security

IV. Cybersecurity

V. Physical Security

Willis H. Thomas, PhD, PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

SUMMIT D 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

16:30

Close of Conference

Agenda

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

DAY ONE TUESDAY 13 MARCH 2018

12:15

Main Conference Registration

13:15

Chairman’s Welcome and Opening Remarks

Willis H. Thomas, PhD, PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

13:30

KEYNOTE ADDRESS Regulatory Pulse on Emerging Enforcement Trends and Recent Warning Letters

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

14:15

Performing an Impact Assessment to Support Quality Risk Management

Willis H. Thomas, PhD, PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

15:00

Networking and Refreshment Break

15:30

DATA INTEGRITY SPOTLIGHTA New Wave of Risk — Proactive Strategies for the Prevention and
Remediation of Data Integrity Non-Compliance

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

16:15

Presentation of IVT’s 2017 Ken Chapman Award

16:20

Remembering Ken Chapman — Points to Consider for 3-Stage PV

Cliff Campbell, BE
Principal
Cliff Campbell Consulting Ltd.

17:00

Close of Day One

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

DAY TWO WEDNESDAY 14 MARCH 2018

7:30 EYE-OPENING BREAKFAST DISCUSSION
Serialisation — How are we doing? Sharing Lessons Learned for Continuous Improvement

Willis H. Thomas, PhD, PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

8:30–10:00

CHOOSE FROM THREE 90-MINUTE SESSIONS (1-3)

SESSION 1Validation Documentation—Initiation, Plan, Protocol and Results

I. Validation Documents Overview, Approach, Hierarchy and Contents

II. Lifecycle Approach to Process Validation

III. Validation Initiation

IV. Validation Plan

V. Validation Protocol

VI. Validation Results

VII. Miscellaneous Documentation Topics

VIII. Interactions — Throughout Discussion

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology
and Journal of GXP Compliance IVT/CBI/UBM
;
Associate Professor, Biopharmaceutics,
University of Illinois at Chicago (UIC) College of Pharmacy

SESSION 2Introduction to Statistics in Validation for the Non-Statisticians

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

SESSION 3Equipment Qualification — Ensure Fit for Intended Use

I. Types of Qualification

II. Validating Equipment — Keeping it Simple

III. Interactive Exercise

Mary Sexton
B.Eng, Production Validation Engineer
Servier

10:00 Networking and Refreshment Break

10:30–12:00

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

SESSION 5Validation Master Plan Development

I. Overview

II. Validation Master Plan — Site Document

III. Validation Master Plan — Function Document

IV. Validation Master Plan — Major Project

V. Validation Project Plan — All Validation and Qualification

VI. Miscellaneous Topics

VII. Interactive Discussion

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology
and Journal of GXP Compliance IVT/CBI/UBM
;
Associate Professor, Biopharmaceutics,
University of Illinois at Chicago (UIC) College of Pharmacy

SESSION 6Acceptance Criteria for Validations

I. What are Acceptance Criteria?

II. How to Think about Acceptance Criteria in Process and Test
Method Validation

III. Setting Acceptance Criteria to Meet the Needs of the Product
and/or Process

IV. Risk-Based Decisions

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

12:00 Networking Luncheon

13:00–14:30

CHOOSE FROM THREE 90-MINUTE SESSIONS (7-9)

SESSION 7Align Validation with FDA’s Quality Metrics Guidance — What You Need to Know

I. Regulations, Guidance and Current Inspectional Issues

II. Developing Metrics for Validation

III. Interactive Exercise

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

SESSION 8Integration of Risk into Change Control

I. Review of Change Control

II. Evaluate Change Control Systems

III. Develop a Consistent and Direct Method to Assess Impact of Changes

IV. Implementation of Change

V. Interactive Exercise

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

SESSION 9Proper Audit Planning to Ensure Maximum Effectiveness and Efficiency

I. Interactive Discussion — What Constitutes a Successful Audit?

II. Audit Schedules

III. Audit Planning

IV. Audit Conduct

V. Audit Reporting

VI. Follow-Up Processes

Chris Wubbolt
Principal
QACV Consulting

14:30

Networking and Refreshment Break

15:00–16:30

CHOOSE FROM THREE 90-MINUTE SESSIONS (10-12)

SESSION 10Understand, Detect and Control Variation NEW: ICH Q12 Draft, USP <1220>

I. Understanding Variation

II. Reducing and Controlling Variation

III. Interactive Exercise

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

SESSION 11Global Problems in Cleaning and Cleaning Validation—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. Self-Audit Questions

VIII. Interactive Discussion During Presentation

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology
and Journal of GXP Compliance IVT/CBI/UBM
;
Associate Professor, Biopharmaceutics,
University of Illinois at Chicago (UIC) College of Pharmacy

SESSION 12Manufacturing Execution Systems

I. Introduction

II. MES Operation

III. Benefits of MES

Mary Sexton
B.Eng, Production Validation Engineer
Servier

16:30

Close of Day Two

DAY THREE THURSDAY 15 MARCH 2018

8:00

Continental Breakfast

8:30

Validation Efficiency Improvements and Cost Reduction

I. Challenges in Validation that Impact Efficiency and Cost

II. Cost Effective Streamlined Efficient Strategies

III. Innovative Approach that Enable Efficiency and Cost Reduction

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

10:00

Networking and Refreshment Break

10:30–12:00

CHOOSE BETWEEN TWO IN-DEPTH WORKSHOPS (II-III)

WORKSHOP II: Develop and Implement Risk-Based Approaches
for Data Integrity

I. Examples of Data Integrity Issues

II. Measures to Detect Data Integrity Issues

III. Interactive Exercise

Workshop Leader:

Chris Wubbolt
Principal
QACV Consulting

WORKSHOP III: An Innovative Approach to C&Q — Practical Guide to Establish a Simplified and Automated Risk-Based Commissioning and Qualification (C&Q) Process

I. Discussion of Improved C&Q Business Process

II. BioPharma User Case Study Reporting Use of Improved C&Q Process

III. Review of Automated C&Q Process with Q&A

Workshop Leaders:

Lou Killian
Director Customer Success
Kneat Solutions Inc.

Rick Mineo
Founder and President
Encova Consulting

12:00

Networking Luncheon and Vendor Prize Card Drawing

13:00–14:30

CHOOSE BETWEEN TWO 90-MINUTE SUMMITS (A-B)

SUMMIT APurified Water Design

I. Introduction

II. Typical Purified Water System Design

III. Routine Operation

Mary Sexton
B.Eng, Production Validation Engineer
Servier

SUMMIT B Think Tank on Criticality as a Continuum

Cliff Campbell, BE
Principal
Cliff Campbell Consulting Ltd.

14:30

Networking Luncheon

15:00–16:30

CHOOSE BETWEEN TWO 90-MINUTE SUMMITS (C-D)

SUMMIT C Safeguard Data — Risk-Based Cyber Security

I. Risk Assessment — Vulnerability

II. Information Security

III. Environmental Security

IV. Cybersecurity

V. Physical Security

Willis H. Thomas, PhD, PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

SUMMIT D 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

16:30

Close of Conference