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.
Leaders:
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)
Speakers:
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! (
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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:
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.