Skip navigation
Laboratory Data Integrity
14th Annual Specialty Therapies
Sponsors
STERIS
BioTechLogic
GxP Manager
Sparta Systems
Rescop
Molecular Devices
Empowerment QE

IVT’s 3rd Annual Validation Week Europe

Industry’s Most Comprehensive Event Dedicated to Validation

March 28-30, 2012

Agenda

Want more agenda details? Download the brochure.
Wednesday March 28, 2012
11:30 am

Main Conference Registration


12:45 pm

Chairperson’s Welcome and Opening Remarks

Karen S. Ginsbury B.Pharm, M.Sc, MRPharmS
President
PCI Pharmaceutical Consulting Israel Ltd.

1:00 pm

Create a Corporate Process Validation Paradigm — The Impact of FDA’s Process Validation Guidance One Year After Release

Karen S. Ginsbury B.Pharm, M.Sc, MRPharmS
President
PCI Pharmaceutical Consulting Israel Ltd.

1:40 pm

Qualification & Validation — Regulatory and Inspectional Findings — IMB Perspective

Kevin O’Donnell
Senior Inspector & Market Compliance Manager
Irish Medicines Board

2:20 pm

Taking the Next Step – From Validation to Enterprise Quality Management

Paula Gilsenan
Validation Specialist
Coloplast A/S
Charlotte Savolainen
Validation Specialist
Coloplast A/S
Bastian Scharpen
Solution Consultant
Sparta Systems

2:20 pm

Taking the Next Step – From Validation to Enterprise Quality Management

Paula Gilsenan
Validation Specialist
Coloplast A/S
Charlotte Savolainen
Validation Specialist
Coloplast A/S
Bastian Scharpen
Solution Consultant
Sparta Systems

2:20 pm

Taking the Next Step – From Validation to Enterprise Quality Management

Paula Gilsenan
Validation Specialist
Coloplast A/S
Charlotte Savolainen
Validation Specialist
Coloplast A/S
Bastian Scharpen
Solution Consultant
Sparta Systems

3:00 pm

Networking and Refreshment Break


Choose Between Three 90-minute Sessions (1-3)


3:15 pm

Session 1 • Implement Process Validation Company-wide — A Pharmaceutical Case Study


3:15 pm

Session 2 • Implement Process Validation Company-wide — A Medical Device Approach

Jacalyn Schroeder
Process Validation Engineering Specialist
3M Company

3:15 pm

Session 3 • Quality by Design (QbD) and Process Validation (PV) — Complimentary Pharmaceutical Lifecycle Approaches

Paul L. Pluta Ph.D.
Editor in Chief, Journal of Validation Technology and Journal of GXP Compliance, The Institute of Validation Technology; Adjunct Associate Professor, University of Illinois

4:45 pm

Close of Day One


4:45 pm - 5:45 pm

Networking, Wine & Cheese Reception Hosted by Sparta Systems


Thursday March 29, 2012
7:30 am

Continental Breakfast Sponsored by Steris


7:30 am

Breakfast Discussion – Understand, Reduce and Control Variation

Karen S. Ginsbury B.Pharm, M.Sc, MRPharmS
President
PCI Pharmaceutical Consulting Israel Ltd.

Choose From 3 Interactive Workshops (A-C)


8:30 am - 12:00 pm

Workshop A • Validation Documents — Plans, Protocols, Acceptance Criteria and Result

Paul L. Pluta Ph.D.
Editor in Chief, Journal of Validation Technology and Journal of GXP Compliance, The Institute of Validation Technology; Adjunct Associate Professor, University of Illinois

8:30 am - 12:00 pm

Workshop B • A Case Study on Implementing an Effective CSV Program Company-wide

Chris Brickner
Senior Software Quality Engineer
Physio-Control Inc.

8:30 am - 12:00 pm

Workshop C • Senior-Level Think Tank — Strategies for the Advanced Validation Professional

Karen S. Ginsbury B.Pharm, M.Sc, MRPharmS
President
PCI Pharmaceutical Consulting Israel Ltd.

12:00 pm

Networking Luncheon


Choose Between Three 90-minute Session (4-6)


1:15 pm

Session 4 • A Risk-Based Approach to Cleaning Validation

Michael Gietl
Technical Service Specialist
STERIS Corporation Life Sciences

1:15 pm

Session 5 • Construction of an Effective Validation Master Plan (VMP)

Karen S. Ginsbury B.Pharm, M.Sc, MRPharmS
President
PCI Pharmaceutical Consulting Israel Ltd.

1:15 pm

Session 6 • Use Statistics throughout the Validation Lifecycle — An Applied Approach

Jacalyn Schroeder
Process Validation Engineering Specialist
3M Company

2:45 pm

Networking and Refreshment Break


Choose Between Three 90-minute Session (7-9)


3:15 pm - 4:45 pm

Session 7 • Transition from Process Qualification to Continued Process Verification (CPV)

Kurtis Epp
Manufacturing Manager
BioTechLogic, Inc.

3:15 pm

Session 8 • Understand, Reduce and Control Variation — Reduce Quality Costs by Improving the Reproducibility of a Process

Karen S. Ginsbury B.Pharm, M.Sc, MRPharmS
President
PCI Pharmaceutical Consulting Israel Ltd.

3:15 pm

Session 9 • Computer Systems Change Control — Maintain the Validated State

Barbara Nollau
Director, Supplier & Alliances Quality
Abbott Vascular

4:45 pm

Close of Day Two


Friday March 30, 2012
7:30 am

Continental Breakfast


7:30 am - 8:30 am

Roundtable Breakfast • Analytical Method Validation


Choose Between Three 90-minute Session (10-12)


8:30 am

Session 10 • Establish Acceptance Criteria for Process Validation

Peter Amanatides
Vice President, QA and QC
Noven Pharmaceuticals Inc

8:30 am

Session 11 • The Role of Organisational Change Management in a Validation Project

Barbara Nollau
Director, Supplier & Alliances Quality
Abbott Vascular

8:30 am

Session 12 • Effectively Conduct a Gap Analysis of Your Validation Program

Stephen Galvin
B.Sc. (Hons), M.Sc., Process Validation Lead
Eli Lilly S.A – Irish Branch

10:00 am

Networking Refreshment Break


Choose Between Four 90-minute Session (13-15)


10:30 am

Session 13 • Qualification of Critical Utilities in Drug Manufacturing

Gamal Amer Ph.D.
Gamal Amer, Principal, Premier Compliance; Adjunct Professor, Chemical Engineering
Widener University

10:30 am

Session 14 • Equipment Qualification — Fit for Intended Use

Paul L. Pluta Ph.D.
Editor in Chief, Journal of Validation Technology and Journal of GXP Compliance, The Institute of Validation Technology; Adjunct Associate Professor, University of Illinois

10:30 am

Session 15 • Transition from a V Model to a Risk-Based Approach for Validation

Frits Vogt
Manager Validation Services
Fresenius Kabi

12:00 pm

Networking Luncheon


Choose Between Three 90-minute Session (16-18)


1:00 pm

Session 16 • Streamline the Validation Process

Elaine Kelleher
Validation Lead
Merck, Sharp and Dohme

1:00 pm

Session 17 • Apply FDA’s New Guidance to Cleaning Validation

Paul L. Pluta Ph.D.
Editor in Chief, Journal of Validation Technology and Journal of GXP Compliance, The Institute of Validation Technology; Adjunct Associate Professor, University of Illinois

1:00 pm

Session 18 • Avoid CSV Pitfalls by Knowing Warnings from FDA — A Review of Recent Enforcement Actions, 483s and Warning Letters

Chris Brickner
Senior Software Quality Engineer
Physio-Control Inc.

2:30 pm

Networking Refreshment Break


Choose Between Three 90-minute Session (19-21)


2:45 pm

Session 19 • Audit Vendors on Validation Practice

Gamal Amer Ph.D.
Gamal Amer, Principal, Premier Compliance; Adjunct Professor, Chemical Engineering
Widener University

2:45 pm

Session 20 • Go Global and Standardise Validation Practice in a Global Organisation

Frits Vogt
Manager Validation Services
Fresenius Kabi

2:45 pm

Session 21 • Utilise Risk Management Techniques in Validation


4:15 pm

Close of Conference


Agenda

Want more agenda details? Download the brochure.