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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA New England Chapter Quality Management Systems Dinner Meeting

Sep 20 - Sep 20, 2017 |
Sep 20, 2017 |
Westford Regency Inn | Westford, MA
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Invest in your education! Join The PDA New England Chapter on Wednesday, September 20 at the Westford Regency Inn in Westford, MA.

General Meeting Format

Sponsors can begin setting up at 4:45 p.m.
Registration/cocktails/social hour with sponsors: 5:30 - 6:30 p.m.
Dinner starts approximately 6:30 p.m.
Introductions and presentations begin at approx. 7:00 p.m.


Transforming Change Management with Modern Systems, Mike Jovanis from Veeva
Assessing impact and creating and executing a change plan are difficult with global stakeholders and multitude of systems. Extensive coordination is often needed between functional areas such as quality, manufacturing and regulatory. Join us and hear how modern systems break down organizational silos - transforming change management. In this session we will discuss providing a framework to systematically assess global operational and regulatory impact; how to gain greater visibility between quality and regulatory departments and how to work together; structuring change releases and putting them into effect in a global environment; and gaining better intelligence and efficient changes for greater agility and better decision making.

Results and Discussion on SOLABS' 2017 Quality Metrics Data Survey, Philippe Gaudreau from SOLABS
In November 2016, the FDA issued a Draft Guidance on the Submission of Quality Metrics Data. SOLABS' 2017 Quality Metric Data Survey aims at understanding how Life Science companies have responded to these requirements. SOLABS completed the survey in July with respondents from about 50 Life Science companies. The results of the survey will be shared and commented on September 20th. The discussion will also include a reporting model to consistently review and publish quality metrics on a periodic basis.


As Vice President of the Vault Quality product suite, Mike Jovanis is responsible for product strategy, customer engagement and business development. He has over 15+ years in life sciences working with customers developing and designing leading quality solutions. Before Veeva, Mike served as Vice President of Product Management and Strategy for Sparta Systems.

As CEO of SOLABS, and almost 18 years after co-founding the company, Philippe Gaudreau continues to grow an avid interest in quality management and compliance practices in the Life Sciences. He is passionate about finding best in class solutions, with the goal of helping SOLABS' Life Sciences clients automate their quality operations without losing the flexibility they have with their manual systems. He offers his expertise through his devotion to software development, his deep knowledge of business process management and optimization, and his expertise in document life cycle management.


  • PDA Members: $75
  • PDA Student Members: Free
  • PDA Retired Members: $10
  • Unemployed Members: $10
  • Non-Members: $95

Not yet a member of PDA? Join today and attend this meeting for free!

Register online by 12:00 Noon, Friday, Sept. 15th
Late registrations will be accepted after noon on September 15th on a space-available basis.

Late Registration is $115 for all. For late registration contact Late registration payment will be accepted at the door. You can now pay for late registration with your credit card.  

Meeting Hosts

Laurie Masiello
Masy BioServices

Henry Brush
Director, Drug Product Manufacturing
Zafgen, Inc.