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Joint Program - Del.Val. & NJ Chapters

Tuesday, July 15, 2014 from 5:00 PM to 8:00 PM (EDT)

Ticket Information

Ticket Type Sales End Price Fee Quantity
Members Ended $65.00 $0.00
Young Professionals Ended $35.00 $0.00
Non - Member Ended $75.00 $0.00
Retired, Unemployed, Student, Faculty Ended Free $0.00
Platinum Sponsorship Ended $500.00 $0.00
Gold Sponsorship Ended $250.00 $0.00

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Event Details

Joint Program

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. 


Presenter

Jenn Walsh 
Bristol-Myers Squibb  

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.


Location 

The Westin Princeton at Forrestal Village

201 Village Boulevard • Princeton, NJ 08540 

 

Price & Registration

Members:  $65 

Young Professionals:  $35 

Non-Member:  $75/$80 

Retired, Unemployed, Student, Faculty:  $0



Sponsorships

 

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.


Schedule


5:00 pm - Registration

6:00 pm - Dinner

7:00 pm - Presentation


Thank you to our Event Sponsor:


Platinum Sponsor:
 


Gold Sponosr:


 

Have questions about Joint Program - Del.Val. & NJ Chapters? Contact the organizer

When & Where


The Westin Princeton at Forrestal Village
201 Village Boulevard
Princeton, NJ 08540

Tuesday, July 15, 2014 from 5:00 PM to 8:00 PM (EDT)


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