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Agenda

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

May 21-23, 2019
  • Amsterdam, The Netherlands

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY 21 MAY 2019

7:30

Registration and Welcome Refreshments

8:30–12:00

CHOOSE FROM THREE INTERACTIVE WORKSHOPS (A-C)

A Validation and Qualification Overview — Approach, Documentation, Management and Applications

I. Outline, Definitions and Objectives

II. Process Validation and Qualification

III. Documentation

IV. Validation Approval Committee

V. Validation Quality System Management

VI. Applications of Validation Principles

Frits Vogt
Consultant for the Life Sciences
ValserV

B A Disruptive Approach to Data Integrity —
Digital Maturity, Big Data, Scale-Out and Other
Tools for Integration of Automation

I. The Current State of Play

II. Digital Maturity

III. Integration of Automation

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

C Laboratory Analytical Method Validation — Implementing Best Practices

I. Overview

II. Process — Laboratory Analytical Method Validation

III. Implementation — Laboratory Analytical Method Validation

IV. Analytical Method Validation Report — Data Analyses and Report

V. Interactive Exercise

Lina Patel, PhD
Director, Quality Operations Technical
Merck

*There will be a 30-minute networking break at 10:00am

12:00

Networking Luncheon

13:15

Chairperson’s Welcome and Opening Remarks

Henrietta Vinnerås
Senior Manager, Microbiology & Aseptic Technique,
Global Manufacturing Pharmaceuticals
Fresenius Kabi Sweden

13:30

Focus on EudraLex Annex 1 Revision — Design and Validation of Cleanrooms and Processes throughout the Product Lifecycle

Henrietta Vinnerås
Senior Manager, Microbiology & Aseptic Technique,
Global Manufacturing Pharmaceuticals
Fresenius Kabi Sweden

14:15

Cleaning Validation in a Pharmaceutical Manufacturing Environment

Marc Vorderman
Director, Europe
Novatek

Aram Mantazami
Vice President, R&D and Co-Founder
Novatek

15:15

PIONEERING PERSPECTIVES Validation Vision for Pharma 4.0 —
Revolutionary Concepts for the Emerging Paradigm

FACILITATOR:

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

16:15

Close of Day One

Networking, Wine &
Cheese Reception
Celebrating 10 Years of Validation Week Europe!
Mingle with colleagues and make new contacts.

DAY TWO WEDNESDAY 22 MAY 2019

7:30 EYE-OPENING MORNING DISCUSSION

Sanity Check on Investigations — Correlation Is NOT Causation

Come and find out why everything you thought about investigations needs re-assessment. Using provocative questions, challenge classic approaches to conducting investigations and show why correlation is not equivalent to causation — an error which results in repeat deviations and frustration. Take away some new tools for getting to grips with and conducting more robust investigations into deviations and non-conforming events.

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

8:15

Brief Transition Break

8:30–10:00

CHOOSE FROM THREE CONCURRENT SESSIONS (1-3)

1 Effective and Efficient Data Integrity Audits

I. Before Audit

II. During Audit

III. After Audit

IV. Interactive Exercise

Morcos Loka
Training Manager and GMP Advisor
Minapharm

2 Validation Statistics for the Non-Statistician

I. Concept and Importance of Variance

II. Expressing Variance

III. Process Capability

IV. Setting up a Validation Sampling Plan

V. Acceptance Criteria for Test Method Validation

VI. Statistical Process Controls

VII. Conclusion and Discussion

Alan Golden
Principal, Design Quality Consultants;
former Principal Quality Professional,
Product Quality Operations Support, Abbott Molecular

3 Problems in Process Validation Documentation — Enhancing Protocol and Report Writing

I. Outline, Definitions and Objectives

II. FDA Lifecycle Approach to Process Validation

III. Stage 1 — Design and Development Document Problems

IV. Stage 2 — Demonstration Document Problems

V. Stage 3 — Continued Process Verification Document Problems

VI. Program Implementation

VII. Technical Writing and Report Protocol

VIII. Self-Audit Questions — Topics for Consideration to Evaluate Severity and Prioritization of Problems

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

10:00

Networking and Refreshment Break —
Mingle in the Exhibit Hall and Get Technical Questions Answered

10:30–12:00

CHOOSE FROM THREE CONCURRENT SESSIONS (4-6)

4 Implement Change Control Procedures in Validation

I. The Need for Change Control

II. What Is Change Control?

III. Establishing a Change Control System

IV. Examples of Good (and Bad) Change Control

V. Change Control and the FDA

Alan Golden
Principal, Design Quality Consultants;
former Principal Quality Professional,
Product Quality Operations Support, Abbott Molecular

5 Validation Competency—Designing a Training and Development Program to Reinforce Compliance in Validation-Related Activities

Ensuring validation professionals maintain on-the-job competency is central to the success of the quality function. If there is a lack of technical and behavioral skills, an organization may realize a significant loss in investment in human capital. This session is aimed at sustaining organizational learning for validation professionals through targeted training and development.

I. Interactive Activity

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

6 CASE STUDY Validation and Qualification —
Risk Management Case Study

I. Risk Management

II. Application of Risk Management

III. Risk Management in Validation and Qualification

IV. Interactive Exercise

Frits Vogt
Consultant for the Life Sciences
ValserV

12:00

Networking Luncheon

13:00–14:30

CHOOSE FROM TWO CONCURRENT SESSIONS (8-9)

8 Human Error Reduction in Validation Related Activities — Corrective and Preventative Action (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.

I. Interactive Activity

Willis Thomas, PhD, PMP, CPT
Director, Learning and Development
Akorn Pharmaceuticals

9 CASE STUDY Quality Risk Management —
Case Study on the Introduction of a
New Product to an Existing Facility

I. Risk Initiation

II. GMP Guidelines and Industry Guidance

III. Risk Assessment

IV. Risk Control

V. Risk Review

VI. Risk Communication

VII. Interactive Exercise

Morcos Loka
Training Manager and GMP Advisor
Minapharm

14:30

Networking and Refreshment Break —
Mingle in the Exhibit Hall and Get Technical Questions Answered

15:00 Mock Validation Inspection —
Are You Ready to Handle the Investigator?

In these mock inspections, our team of experienced facilitators challenge the audience with typical validation inspectional scenarios and you will have a chance to see if your approach and responses work well, as well as, hearing tips from other practitioners as to how to do better.

FACILITATORS:

Willis Thomas, PhD, PMP, CPT
Director, Learning and Development
Akorn Pharmaceuticals

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

Lina Patel, PhD
Director, Quality Operations Technical
Merck

16:30

Close of Day Two

DAY THREE THURSDAY 23 MAY 2019

8:00

Morning Refreshments

8:30

11 Post-Approval CMC Changes with Matrix Approach
and GSK Experience

Post-approval CMC changes are inherent to the lifecycle management of any registered vaccine. Reduced-design validation strategies such as a matrix validation approach allow for a robust evaluation of multi-product changes, applying scientifically-based rationales. During the past decade, changes validated applying a matrix approach have been successfully implemented to register multi-product transfers to new facilities and changes in raw materials. During this session, discuss the acceptance of the matrix approach as a robust validation practice and the progress needed to fully embed the concept in global guidelines.

Abdelmoughit Kaoukab, PhD
Manager, CMC, Global Regulatory Affairs
GSK

9:15

CHOOSE BETWEEN TWO CONCURRENT SESSIONS (13-14)

13 Implement a Validation Framework for a
Corporate Data Lake in the Cloud —
Risks, Controls and Multiple Process Ownership

In times of big data and advanced analytics, it is key to implement corporate platforms that enable the handling of big amounts of data from multiple (internal or external) sources. If GxP data is involved, then such systems shall be validated. Usually for a computerized system, process ownership is well defined, but what happens if we have data from different sources, for different purposes and following different processes? For this reason, it was necessary to create a validation approach that can deal with these challenges compliantly. If this platform is implemented on a cloud infrastructure additional risks and controls shall be implemented.

Daniel Caparros
Head Global Quality Strategy, Data and Vendors
Merck KGaA

14 Integrate Quality by Design into Process Validation, Qualification and Quality Systems

I. Outline, Definitions and Objectives

II. Process Validation Lifecycles

III. QbD Definition

IV. QbD Implementation into Lifecycle

V. QbD Applications

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

10:00

Networking and Refreshment Break

10:30 BYOC — Bring Your Own Challenge Workshop

During this unique workshop, validation professionals from pharmaceutical, biotech and medical device companies share their greatest pain points and then collaborate with their industry counterparts 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.

Lina Patel, PhD
Director, Quality Operations Technical
Merck

12:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY 21 MAY 2019

7:30

Registration and Welcome Refreshments

8:30–12:00

CHOOSE FROM THREE INTERACTIVE WORKSHOPS (A-C)

A Validation and Qualification Overview — Approach, Documentation, Management and Applications

I. Outline, Definitions and Objectives

II. Process Validation and Qualification

III. Documentation

IV. Validation Approval Committee

V. Validation Quality System Management

VI. Applications of Validation Principles

Frits Vogt
Consultant for the Life Sciences
ValserV

B A Disruptive Approach to Data Integrity —
Digital Maturity, Big Data, Scale-Out and Other
Tools for Integration of Automation

I. The Current State of Play

II. Digital Maturity

III. Integration of Automation

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

C Laboratory Analytical Method Validation — Implementing Best Practices

I. Overview

II. Process — Laboratory Analytical Method Validation

III. Implementation — Laboratory Analytical Method Validation

IV. Analytical Method Validation Report — Data Analyses and Report

V. Interactive Exercise

Lina Patel, PhD
Director, Quality Operations Technical
Merck

*There will be a 30-minute networking break at 10:00am

12:00

Networking Luncheon

13:15

Chairperson’s Welcome and Opening Remarks

Henrietta Vinnerås
Senior Manager, Microbiology & Aseptic Technique,
Global Manufacturing Pharmaceuticals
Fresenius Kabi Sweden

13:30

Focus on EudraLex Annex 1 Revision — Design and Validation of Cleanrooms and Processes throughout the Product Lifecycle

Henrietta Vinnerås
Senior Manager, Microbiology & Aseptic Technique,
Global Manufacturing Pharmaceuticals
Fresenius Kabi Sweden

14:15

Cleaning Validation in a Pharmaceutical Manufacturing Environment

Marc Vorderman
Director, Europe
Novatek

Aram Mantazami
Vice President, R&D and Co-Founder
Novatek

15:15

PIONEERING PERSPECTIVES Validation Vision for Pharma 4.0 —
Revolutionary Concepts for the Emerging Paradigm

FACILITATOR:

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

16:15

Close of Day One

Networking, Wine &
Cheese Reception
Celebrating 10 Years of Validation Week Europe!
Mingle with colleagues and make new contacts.

DAY TWO WEDNESDAY 22 MAY 2019

7:30 EYE-OPENING MORNING DISCUSSION

Sanity Check on Investigations — Correlation Is NOT Causation

Come and find out why everything you thought about investigations needs re-assessment. Using provocative questions, challenge classic approaches to conducting investigations and show why correlation is not equivalent to causation — an error which results in repeat deviations and frustration. Take away some new tools for getting to grips with and conducting more robust investigations into deviations and non-conforming events.

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

8:15

Brief Transition Break

8:30–10:00

CHOOSE FROM THREE CONCURRENT SESSIONS (1-3)

1 Effective and Efficient Data Integrity Audits

I. Before Audit

II. During Audit

III. After Audit

IV. Interactive Exercise

Morcos Loka
Training Manager and GMP Advisor
Minapharm

2 Validation Statistics for the Non-Statistician

I. Concept and Importance of Variance

II. Expressing Variance

III. Process Capability

IV. Setting up a Validation Sampling Plan

V. Acceptance Criteria for Test Method Validation

VI. Statistical Process Controls

VII. Conclusion and Discussion

Alan Golden
Principal, Design Quality Consultants;
former Principal Quality Professional,
Product Quality Operations Support, Abbott Molecular

3 Problems in Process Validation Documentation — Enhancing Protocol and Report Writing

I. Outline, Definitions and Objectives

II. FDA Lifecycle Approach to Process Validation

III. Stage 1 — Design and Development Document Problems

IV. Stage 2 — Demonstration Document Problems

V. Stage 3 — Continued Process Verification Document Problems

VI. Program Implementation

VII. Technical Writing and Report Protocol

VIII. Self-Audit Questions — Topics for Consideration to Evaluate Severity and Prioritization of Problems

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

10:00

Networking and Refreshment Break —
Mingle in the Exhibit Hall and Get Technical Questions Answered

10:30–12:00

CHOOSE FROM THREE CONCURRENT SESSIONS (4-6)

4 Implement Change Control Procedures in Validation

I. The Need for Change Control

II. What Is Change Control?

III. Establishing a Change Control System

IV. Examples of Good (and Bad) Change Control

V. Change Control and the FDA

Alan Golden
Principal, Design Quality Consultants;
former Principal Quality Professional,
Product Quality Operations Support, Abbott Molecular

5 Validation Competency—Designing a Training and Development Program to Reinforce Compliance in Validation-Related Activities

Ensuring validation professionals maintain on-the-job competency is central to the success of the quality function. If there is a lack of technical and behavioral skills, an organization may realize a significant loss in investment in human capital. This session is aimed at sustaining organizational learning for validation professionals through targeted training and development.

I. Interactive Activity

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

6 CASE STUDY Validation and Qualification —
Risk Management Case Study

I. Risk Management

II. Application of Risk Management

III. Risk Management in Validation and Qualification

IV. Interactive Exercise

Frits Vogt
Consultant for the Life Sciences
ValserV

12:00

Networking Luncheon

13:00–14:30

CHOOSE FROM TWO CONCURRENT SESSIONS (8-9)

8 Human Error Reduction in Validation Related Activities — Corrective and Preventative Action (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.

I. Interactive Activity

Willis Thomas, PhD, PMP, CPT
Director, Learning and Development
Akorn Pharmaceuticals

9 CASE STUDY Quality Risk Management —
Case Study on the Introduction of a
New Product to an Existing Facility

I. Risk Initiation

II. GMP Guidelines and Industry Guidance

III. Risk Assessment

IV. Risk Control

V. Risk Review

VI. Risk Communication

VII. Interactive Exercise

Morcos Loka
Training Manager and GMP Advisor
Minapharm

14:30

Networking and Refreshment Break —
Mingle in the Exhibit Hall and Get Technical Questions Answered

15:00 Mock Validation Inspection —
Are You Ready to Handle the Investigator?

In these mock inspections, our team of experienced facilitators challenge the audience with typical validation inspectional scenarios and you will have a chance to see if your approach and responses work well, as well as, hearing tips from other practitioners as to how to do better.

FACILITATORS:

Willis Thomas, PhD, PMP, CPT
Director, Learning and Development
Akorn Pharmaceuticals

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

Lina Patel, PhD
Director, Quality Operations Technical
Merck

16:30

Close of Day Two

DAY THREE THURSDAY 23 MAY 2019

8:00

Morning Refreshments

8:30

11 Post-Approval CMC Changes with Matrix Approach
and GSK Experience

Post-approval CMC changes are inherent to the lifecycle management of any registered vaccine. Reduced-design validation strategies such as a matrix validation approach allow for a robust evaluation of multi-product changes, applying scientifically-based rationales. During the past decade, changes validated applying a matrix approach have been successfully implemented to register multi-product transfers to new facilities and changes in raw materials. During this session, discuss the acceptance of the matrix approach as a robust validation practice and the progress needed to fully embed the concept in global guidelines.

Abdelmoughit Kaoukab, PhD
Manager, CMC, Global Regulatory Affairs
GSK

9:15

CHOOSE BETWEEN TWO CONCURRENT SESSIONS (13-14)

13 Implement a Validation Framework for a
Corporate Data Lake in the Cloud —
Risks, Controls and Multiple Process Ownership

In times of big data and advanced analytics, it is key to implement corporate platforms that enable the handling of big amounts of data from multiple (internal or external) sources. If GxP data is involved, then such systems shall be validated. Usually for a computerized system, process ownership is well defined, but what happens if we have data from different sources, for different purposes and following different processes? For this reason, it was necessary to create a validation approach that can deal with these challenges compliantly. If this platform is implemented on a cloud infrastructure additional risks and controls shall be implemented.

Daniel Caparros
Head Global Quality Strategy, Data and Vendors
Merck KGaA

14 Integrate Quality by Design into Process Validation, Qualification and Quality Systems

I. Outline, Definitions and Objectives

II. Process Validation Lifecycles

III. QbD Definition

IV. QbD Implementation into Lifecycle

V. QbD Applications

Karen Ginsbury, BPharm, MSc
CEO
PCI Pharmaceutical Consulting Ltd.

10:00

Networking and Refreshment Break

10:30 BYOC — Bring Your Own Challenge Workshop

During this unique workshop, validation professionals from pharmaceutical, biotech and medical device companies share their greatest pain points and then collaborate with their industry counterparts 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.

Lina Patel, PhD
Director, Quality Operations Technical
Merck

12:00

Close of Conference