Joint Program - Del.Val. & NJ Chapters
Tuesday, July 15, 2014 from 5:00 PM to 8:00 PM (EDT)
San Francisco, California
London, United Kingdom
Del.Val. & NJ Chapters
July 15, 2014
Topic: Business Benefits of Using a PV Lifecycle
Approach - Return on Investment Model
In January 2011, the FDA issued a Guidance for Industry on "Process Validation: General Principles
and Practices". EMA and ASEAN authorities have also issued similar guidance in the area of
lifecycle validation. This presentation will discuss how BMS has implemented a lifecycle approach to
validation and how organizations can benefit from the expectations set forth in current regulatory
guidance in the area of lifecycle validation.
Who Should Attend?
As the regulatory and technical aspects of the Life Science industry blend across Biotechnology, Pharmaceuticals & Medical Device: Engineers and managers from the Facility, Technical, Process, Validation, Process Design, Project Management, Facility Design, and Automation Design groups; Regulatory, scientists, specialists and managers from Quality Control, and Quality Assurance.
Jenn Walsh is an Associate Director within the Manufacturing Science and Technology group at Bristol-Myers Squibb. Her expertise is in Validation and Technology Transfer of drug product processes (non-sterile/bio-sterile). Jenn is a trained Lean Six Sigma black belt and leads the BMS Product Robustness program for US/PR sites, seeking to ensure reliable process performance and on-time product delivery. Previous experiences include roles within both Merck and Schering Plough. Jenn is currently co-chair of the ISPE Lifecycle Approach to PV Implementation team and a co-author for the ISPE Stage 3 Continued Process Verification (2012) and Evaluation of Impact of Statistical Tools on Process Performance Qualification Outcomes (2014) Discussion Papers. Jenn holds an engineering degree from Drexel University.
The Westin Princeton at Forrestal Village
201 Village Boulevard • Princeton, NJ 08540
Price & Registration
Young Professionals: $35
Retired, Unemployed, Student, Faculty: $0
Platinum - $500
Includes - Name recognition on all event announcements, ISPE NJ Newsletter and 2 free entries.
Gold - $250
Includes - Name recognition on all event announcements & ISPE NJ Newsletter.
5:00 pm - Registration
6:00 pm - Dinner
7:00 pm - Presentation
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