Wednesday, May 17, 2017, 5:30 pm to 9:00 p.m.
2 Forbes Road, Woburn, MA 01801
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.
Topic #1: The Role and Purpose of Data - Before, During and After Qualification
Computers and data have become ubiquitous in manufacturing technology and in the science of validation. This presentation will use controlled storage and monitoring as a primary example to discuss and examine:
- the prevalence of data and analytics in equipment design and manufacturing
- leveraging available data to make better decisions toward purchasing, qualification and operation
- how validation and maintaining compliance are reliant on data integrity and quality
- how data and qualification provide a bridge between design and implementation
- the importance of robust data management systems for data monitoring and retention.
Topic #2: Effectively Integrating the Concepts and Principles of Quality by Design (QbD) and QRM into the Life Cycle of Manufacturing Systems
This presentation will demonstrate how to implement the ASTM E2500 standard as a framework for the specification and design and verification of systems, with a focus on early involvement of the quality and validation units throughout the requirements definition and design phases of systems in order to ensure product quality and patient safety. The presentation will also show the effective use of design review and risk assessment to improve system design and formulate a verification strategy based on SME input. With this approach, true quality oversight involves much more SME level interaction than simply review and signature approval.
Sylvan Poeckh, is the Director of Validation for the Pennsylvania branch of Masy BioServices. He has worked in the pharma/biotech industry for over 22 years, with the past 15 years in a validation services role. His validation experience includes qualification and project management for numerous global Fortune 500 companies. Notable examples include Building Automation Systems, Distributed Control Systems for filling and packaging lines, data logging systems, and hundreds of environmentally controlled chambers. Sylvan is a Bachelor of Science in Information Systems degree candidate at Albright College.
Paul Stanovich, is the Managing Partner & Senior Consultant at Process Design Solutions (PDS) & PDS Sandbox. Paul has over 20 years of engineering consulting & executive management experience at multiple global Engineering & Validation companies in the pharmaceutical, biotech & medical device industries. The PDS companies provide process & automation engineering, QbD/QRM, process/product and development/design solutions for Single Use Technology. Paul is an expert in the development, execution, management of engineering/design, commissioning, qualification & validation programs. Paul also has extensive expertise in the implementation of current & new industry trends & best practices such as ASTM E2500, GAMP 5, ICH Q8, Q9 & QbD.
Register online by 12:00 Noon,
Friday, May 12th
- PDA Members: $75
- PDA Student Members: FREE
- PDA Retired Members: $10
- Unemployed Members: $10
- Non-Members: $95
Late registrations will be accepted after noon on May 12th on a space-available basis.
- Late Registration is $115 for all.
For late registration contact
Events@ne-pda.org. Late registration payment will be accepted at the door. You can now pay for late registration with your credit card.
Your Meeting Hosts
Laurie Masiello, President & CEO Masy BioServices
Henry Brush, Director, Drug Product Manufacturing, Zafgen