Case Study of a Greenfield Site’s Positive FDA-PAI Experience with Maintenance and Reliability

Session 101
Facilities and Equipment Track

The Pharmaceutical and Biotech Industry has been so focused on Regulatory Compliance that it has become the core strategy. This topic introduces many tools, techniques, programs and strategies which are deployed across Manufacturing to improve upon utilization rates.

Session Description

Learn about what the FDA is looking at with respect to Maintenance and Reliability. Several examples highlighting the triggers for FDA 483’s and Warning Letters due to poor Maintenance Practices will be shared. The maintenance and reliability thought processes required to ensure compliance while leading good and best practices will be explored and encouraged. Understanding the challenge maintenance and reliability faces to meet regulatory requirements while leading innovative, efficient, effective, on-condition monitoring and world-class maintenance and reliability practices is the highlight of this session. Come prepared to revolutionize your thought processes around maintenance and reliability. The workshop will provide you with personalized guidance on how to accomplish this challenge.

At the conclusion of this session, participants will be able to:

Analyze the aspects of a Maintenance and Reliability program by using a SWOT (Strengths,
Apply the insights from the SWOT and Maintenance and Reliability tools, techniques, programs
Converse and debate the application of many Manufacturing approaches to Maintenance and
Understand the supporting core thought processes behind these Maintenance and Reliability

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom