ISPE Milan Conferences - Kereon AG

Update on the Draft ISPE Maintenance Baseline ® Guide
28-29 November 2005
Conference Leaders
Bob Lennon, Commissioning Agents, USA
Pietro Orombelli, Foster Wheeler, Italy
Conference Description
This Conference will provide an understanding of ISPE’s
Maintenance Baseline ® Guide that is currently in
development. The authors will present the philosophy
and outline of the draft chapters of the Guide developed
to date.
Who Should Attend
• Pharmaceutical maintenance professionals
• Operating departments served by maintenance providers
• Production personnel
• Research and development staff
• QA and compliance personnel
Programme
8
The Guide is a much awaited addition to the Baseline
Pharmaceutical Engineering Series as maintenance
operations are becoming more critical to the operations
that they support from a cost and regulatory
perspective. In particular maintenance departments are
being asked to control costs whilst compliance
requirements are increasing.
Experiences will be shared through case studies by
maintenance professionals from major pharmaceutical
companies and suppliers.
The Maintenance Baseline Guide is currently in
development and is scheduled to be published in 2006.
Learning Objectives
At the conclusion of this conference, delegates will be
able to:
• Understand the philosophy and content of the
Baseline Guide (currently in development)
• Apply techniques to develop maintenance talent and
understand how maintenance organisations are
structured and when to outsource
• Describe experiences of maintenance issues from
regulatory inspections
• Explain how to use a risk-based approach to
maintenance and how to schedule maintenance in
production facilities with high utilisation
• Describe effective parts management
• Understand programmes for production and
maintenance staff – making operators aware of
routine and extraordinary situations
• Understand records management and archiving,
implementing a robust corrective action trail
• Compare preventative maintenance to corrective
maintenance, and understand costs of maintenance
and reducing production downtimes - selling
preventive maintenance to management
Agenda
Monday, 28 November
10.00 - 10.15 Welcome and Introduction
Pietro Orombelli, Foster Wheeler, Italy
10.15 - 10.45 ISPE Maintenance Baseline Guide
Philosophy, Contents, and Status
Pietro Orombelli, Foster Wheeler, Italy
• Guide objectives
• Strategy for guide preparation
• Outline of guide
• Schedule for guide release
• Discussion on approach and content of the guide
10.45 - 11.30 Authority Inspection on Maintenance:
Typical Situations – What You Should Avoid in a
Simulated Audit
Bob Lennon, Commissioning Agents, USA
Pietro Orombelli, Foster Wheeler, Italy
• Typical weak points in maintenance management
• Questions we could expect
• Answers we should avoid
• What could be interesting for a regulatory inspector on
maintenance
11.30 - 12.15 Maintenance Approach: Baseline Practices,
Good Practices and Best Practices
Dennis Clark, Eli Lilly & Company, USA
• Meaning of baseline practices, good practices and best
practices
• Examples of baseline good and best practices in
maintenance
• Risks and opportunities of choosing one approach
12.15 - 13.45 Lunch
ST
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