Track 1: Manufacturing

Monday 14 November - Tuesday 15 November 2011

Worried About Bringing in Your Plant Automation Project on Time and on Budget?
Automation is a key element of biopharmaceutical manufacturing. Yet, for many companies, the management of an automation project can be extremely challenging. Achieving the seemingly conflicting goals of cost effectiveness and full compliance causes problems.
In this highly interactive track, be part of the solution. Participate in instructor-led workshops to understand how validation has evolved and how to achieve full compliance. Help companies and the regulators bring cost effective automation projects to market faster.

William Deckert, Senior Project Manager, Alliance Engineering Incorporated (USA)
Kevin Martin, Senior Vice President, Azzur Group LLC (USA)
Steve Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc. (USA)

Winnie Cappucci, PS Compliance IT Systems NA, Bayer Healthcare - retired (USA)
Hilary Mills Baker, WSP CEL Ltd. (UK)
Gert Moelgaard, Vice President of Strategic Development, NNE Pharmaplan (Denmark)
At the conclusion of this session, participants will be able to:
Understand the interrelationship between Commissioning and Qualification and Computerised Systems Validation from a project standpoint.

Who Should Attend?
Project Managers, Manufacturers, GAMP COP, Commissioning & Qualification COP.

Download the Registration Form for this Conference here! ( 42 KB)

Latest Agenda:

Monday 14 November 2011
9:30 10:30 Keynote Address
10:30 10:50 Refreshment Break
10:50 12:30 Keynote Address
12:30 13:30 Lunch and Networking Break
13:30 13:40 Welcome and Introduction to the Manufacturing Track Session
William Deckert, Alliance Engineering (USA)
13:40 14:30 Session 1 - How to Get a Manufacturing Project Started
Knud Ryhl, Danish Medicines Agency (Denmark)
14:30 15:00 Q&A Session
William Deckert, Alliance Engineering (USA); Knud Ryhl, Danish Medicines Agency (Denmark)
15:00 15:30 Networking Break
15:30 16:10 Session 2 - Project Controls
Developing a total manufacturing project delivery map and integrating process mapping and deliverables
Integration of C&Q and GAMP

Hilary Mills Baker, WSP CEL (UK)
16:10 17:00 Workshop 2 - Interactive Groups to Accelerate Project Interaction and Phased Approach
Tim Howard or Steve Wisniewski, Commissioning Agents (USA)
17:00   Session Adjourns
Tuesday 15 November 2011
8:00 8:10 Welcome and Agenda Review
William Deckert, Alliance Engineering (USA)
8:10 8:50 Session 3 - Design Collaboration and How to Save Money
Kevin Martin, Azzur Group (USA)
8:50 10:00 Manufacturing Systems / C&Q an Integrated Approach
Waunetka Clark, Abbott (USA)
10:00 10:30 Networking Break
10:30 11:00 Session 4 - Workshop: Identifying Waste and Cost Overruns
William Deckert, Alliance Engineering (USA)
11:00 11:30 Session 5 - Solutions for Cost Savings on Manufacturing Projects PM/C&Q/GAMP
Winnie Cappucci, Bayer - retired (USA); William Deckert, Alliance Engineering (USA)
11:30 12:00 Q&A Session
Winnie Cappucci, Bayer - retired (USA); William Deckert, Alliance Engineering (USA)
12:00 13:00 Lunch & Networking Break
13:00 14:00 Session 5 - Pre-Approval Inspection: A Regulator's Viewpoint
Doug Kovacs, FDA (USA) TBC
14:00 14:30 Q&A Session
14:30 15:00 Networking Break
15:00 17:00 ISPE GAMP Conference - Plenary Session

Conference Highlights:

Monday 14 November - Tuesday 15 November 2011

In honour of our 20th Anniversary of GAMP®, ISPE is offering 20% off all GAMP® Guidance Documents in the Guide Series to ISPE Members*.

*Guidance Documents will not be on site. You will be able to complete the order form and ISPE will ship your order to you. If you cancel registration to the conference after purchasing any GAMP Guide(s) you will be charged the full Guidance Document price. 20% discount applies to ISPE Members only.