ISPE-DVC October Program Meeting- Tuesday 10/13

SPEAKER BIO

Track One

Ms. Francesca McBride
Jacobs Consultancy
Director, Quality Systems and Regulatory Affairs

Ms. McBride is responsible for managing all regulatory compliance activities for Jacobs Consultancy PharmaBio Practice globally. For more than 20 years she has provided regulatory compliance and validation expertise to clients seeking facility and product licensing or accreditation by domestic and international regulatory agencies, including the FDA and NIH/CDC in the United States; and the EMA and WHO, internationally. Mc. McBride was assigned to the Jacobs European Region as Manager, Regulatory Compliance from August, 1993, to January 1995. She was responsible for the start up of Regulatory Compliance and Validation in this region. As an integral part of the Jacobs EPCMV teams, she has provided cGMP compliance directions to Jacobs clients and the project team in the facility design requirements and the project planning/scheduling of the integration of construction, commissioning and validation activities to support the project schedule and obtain regulatory approval.
Francesca has a Bachelor of Science in Animal Science from the University of Delaware.

Mr. Louis Isernia
Wyeth
Project Manager

Louis has been a Project Manager for Wyeth since 2001. He has been managing projects for over 20 years primarily in the pharmaceutical and biotechnology field. Louis has led the design effort of projects in both Ireland and the US including a Vaccine Development Lab Expansion, Tableting Expansion, Vaccine Formulations & Aseptic Syringe Filling in an Isolator. His major accomplishment includes the project management of the Grange Castle Drug Product Facility design and construction. Lou is currently completing a Vaccine Formulations Expansion in Pearl River, NY. Prior to joining Wyeth Lou spent 5 years with Raytheon Engineers & Constructors as Manager of Secondary Pharmaceuticals and 15 years with American Cyanamid.

Lou is a graduate of Drexel University with a Masters in Engineering Management.

Track Two

Mr. Andrew Espejo
Wyeth
Director of Maintenance Excellence

Andrew Espejo is the Director of Maintenance Excellence at Wyeth. The Maintenance Excellence program supports all Wyeth Manufacturing and Research facilities by developing long term maintenance strategies as well as identifying predictive and proactive diagnostic systems that will improve the operation, monitoring and maintenance of equipment and facilities.
Andrew just completed a 2 year assignment in Puerto Rico leading the successful Guayama Site Maintenance Excellence Program. He is also the leader of the Reliability Centered Maintenance Community of Practice's (CoP) Planning and Scheduling Common Interest Group (CiG) for Wyeth. The CiG is a network of Maintenance professionals tasked with improving the processes related to Maintenance Planning & Scheduling.
Andrew has a Bachelors of Engineering degree in Mechanical Engineering from Manhattan College and a Masters of Science degree in Mechanical Engineering from Manhattan College. He has worked in the Pharmaceutical industry for 10 years, and has over 20 years of experience in Manufacturing, Construction Management, Engineering, Maintenance and Facilities Operations & Management.