Data Integrity Educational Sessions at INTERPHEX
Experts will discuss regulatory requirements, best practices, and process security for data integrity at INTERPHEX 2018.
Pharmaceutical Technology will present the INTERPHEX Keynote Series: Data Integrity on Wednesday, April 18, 2018 on the show floor at the Innovation Stage, open to all show attendees.
Regulatory Requirements for Data Integrity, Applying ALCOA+: 11–11:30 am
Data integrity is crucial for both the pharmaceutical laboratory and the manufacturing floor. What is data integrity? How can a company ensure data integrity throughout their processes and facilities? Els Poff, Executive Director, Data Integrity Center of Excellence, Merck, representing the PDA Data Integrity Task Force, will answer these questions and more.
Click here to register for INTERPHEX.
Best Practices in Data Integrity and Process Security with Automated Systems: 11:30 am–12:30 pm
A panel of industry experts will discuss how to ensure data integrity with manufacturing automation systems, as well as cybersecurity, best practices for auditing system security, and security concerns associated with the Industrial Internet of Things. Panelists are: Bob Lenich, Global Life Sciences director, Emerson; Torsten Winkler, lead of the Life Sciences Center of Excellence in EMEA for Honeywell Process Solutions; Bob Mehta, Principal Consultant, MasterControl through GMP ISO Expert Services; Mark Cristiano, Manager, North America Business Development Team, Connected Services and Solutions, Rockwell Automation; and Nicolas Teissié, Siemens Industry Software Product Manager.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
The Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy
April 28th 2025Forced degradation studies are critical in biologics development, particularly for monoclonal antibodies (mAbs). These studies simulate long-term environmental stressors to uncover degradation pathways and ensure the stability of critical quality attributes (CQAs), aiding in robust chemistry, manufacturing, and controls (CMC) strategies and regulatory compliance.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
