ISPE and PDA Talk Shop with Validation Experts at Joint Meeting

The ISPE Boston Area Chapter and the PDA New England Chapter are joining forces to present “Validation: The Bridge Between Engineering & Quality Assurance” on May 17. Don’t miss this unique opportunity to exchange ideas with an expanded industry cross section and hear from industry experts Sylvan Poeckh and Paul Stanovich on “The Role and Purpose of Data – Before, During and After Qualification” and “Effectively Integrating the Concepts and Principles of QbD and QRM into the Life Cycle of Manufacturing Systems.”

Computers and data have become ubiquitous in manufacturing technology and in the science of validation. Sylvan Poeckh will use controlled storage and monitoring as a primary example to discuss the prevalence of data and analytics in equipment design and manufacture. Paul Stanovich will demonstrate how to implement the ASTM E2500 standard as a framework for the specification, design and verification of systems and will focus on the early involvement of quality and validation groups to ensure product quality and patient safety.

Sylvan Poeckh 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. Paul Stanovich has over 20 years of engineering consulting and management experience at multiple global engineering and validation companies serving our industry and has extensive experience applying industry guidelines and best practices including ASTM E2500, GAMP 5 and Quality by Design (QbD) in engineering.