Venue change from December! - New Date (February 9, 2023) and Location (Bar Lucca, Conshohocken)

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (2nd Edition, July 2022).

GAMP 5 2nd Edition represents an incremental revision to facilitate the adoption of more recent innovations and technical advances including Agile methodologies, cloud-computing, automated tools, blockchain, AI/ML, and Open Source Software. The guide supports the use of critical thinking to strengthen the risk-based approach to computerized system lifecycles and it facilitates the effective and efficient use of valuable resources by the application of appropriate and proportionate practices, encouraging innovative approaches to managing risk to patient safety, product quality, and data integrity while supporting benefit to public health.

Hear from our esteemed speakers as they explain the guide’s evolving approaches and the importance of applying critical thinking in specific circumstances. In-person attendance is encouraged, but there will also be a virtual option to attend this program.

Agenda:
5:00 - 6:00 PM - Networking (Cash bar - 1st drink is free!)
6:00 - 6:30 PM - Buffet Dinner
6:30 - 8:00 PM - Presentations

Speakers:

Lorrie V. Schuessler
Retired, Chairperson
GAMP Americas

linkedin.com/in/lorrie-vuolo-schuessler-4077b4a

Lorrie Vuolo-Schuessler has been involved with ISPE and the GAMP Community of Practice leadership since 2002. She is currently Chair of the GAMP Americas Steering Committee and a member of the GAMP Global leadership team. She has contributed to the development of the GAMP 5 2ed A Risk-Based Approach to Compliant GxP Computerized Systems and the ISPE GAMP Good Practice Guide (GPG): Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is a co-leader of the recently formed Computer Software Assurance (CSA) Special Interest Group (SIG) and drove the data integrity efforts within GAMP as the co-chair of the recently sunsetted GAMP Data Integrity SIG. The Data Integrity SIG developed multiple GPG’s including: the ISPE GAMP RDI GPG: Data Integrity by Design, the GAMP RDI GPG: Data Integrity – Manufacturing Records, the ISPE GAMP RDI GPG: Data Integrity – Key Concepts, and the ISPE GAMP Records and Data Integrity Guide. Additionally, she has contributed to multiple ISPE/GAMP workshops, webinars, expert exchanges, and trainings.

Stephen Ferrell
VP IT Governance & Software Assurance
CompliancePath Limited - an Ideagen Company

linkedin.com/in/ferrellcisacrisc

Stephen Ferrell has 20+ years of IT Compliance experience in the regulated Life Sciences. Stephen is a member of the GAMP Steering Committee, a US FDA and Chinese NMPA trainer, collaborated with the MHRA to keep a 2 million user SaMD live during Covid, is a contributing author to the ISPE GAMP©5 2nd Edition, the primary author/project lead for the GAMP© IT Infrastructure Control and Compliance Guide and a contributing author to the GAMP© Enabling Innovation Guide. Stephen leads the IT Governance & Software Assurance practices within CompliancePath an Ideagen company.

Paige Kane, PhD, CPIP
Director of Knowledge Management
Merck

linkedin.com/in/paige-kane-phd-2404261

Paige Kane is an industry leader with over 30 years of experience, including Genetics Institute, Wyeth, Pfizer, Monsanto, and US Government. In addition to her 15 years in the field of Knowledge Management, Kane led Quality Systems Groups focusing on Automation Compliance, Data Integrity, Computer Validation, and Change Control during startup and operations for biologics facilities in the US and Ireland. Dr. Kane has been a ISPE member for over 20 years and a member of ISPE author teams including the recent Knowledge Management guide and multiple GAMP guides. She previously led the ISPE Global Biotech CoP and led GAMP regional CoPs (Americas & EU) as well as supporting Student Development activities for Boston and Delaware Valley ISPE Chapters. She is a frequent author and presenter and continues her research as a member of the TU Dublin Pharmaceutical Regulatory Sciences Team. Kane holds a PhD in Pharmaceutical and Regulatory Science from Technical University Dublin (Dublin, Ireland).

Levi Schenk, MS, CSM, CSSBB
Head of I&T Framework and Governance
CSL Behring

linkedin.com/in/levischenk

Levi Schenk is an IT and Quality professional who has spent his career helping to validate, build, and disrupt the current mindset of what a quality management system(QMS) is, as it pertains to Computerizes Systems and Data. Now expanding this reach from the QMS to other operating processes around Project Management, Demand Management, Resource Management and Change Management to create the “Digital Path” which is the Information and Technology groups core operating processes to get from an idea, through to operations, and then eventually retirement; using digital tools to bring the various frameworks (Legal, Quality, InfoSec, and PMO) together.

Registration will open at 5:00pm and a cocktail hour will be held until 6:00pm; a buffet dinner will be served at 6:00pm, followed by the presentations. One complimentary drink ticket will be provided, followed by a cash bar. The program will conclude at 8:00pm.

Location:

Thank you to our sponsors for this event: