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IVT’s 3rd Annual Validation Week Europe

Industry’s Most Comprehensive Event Dedicated to Validation

March 28-30, 2012
  • Ireland, Dublin

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.