ISPE DVC GAMP CoP "Data and Data Integrity – Identifying, Assessing and Protecting Your Data"

Data and Data Integrity – Identifying, Assessing and Protecting Your Data

What is “data” – or "metadata"? What data is important? When does a “system of record” become necessary? You need to understand your organization’s data, it’s impact and how to better leverage it across the operation. Our panel of experts from the Life Sciences realm will present and discuss their perspectives on the state of the art for understanding and addressing these issues.

Agenda:

• 5:30 - 6:30 PM    Appetizers, Cocktails & Networking
• 6:30 - 8:00 PM    Panel Session
• 8:00 - 8:30 PM    Socializing & Meeting Adjourned

Moderator:

Dirk Sweigart, PMP, CISSP

Dirk Sweigart is currently the MES Solutions Manager at Applied Control Engineering, Inc. (ACE) in Newark, DE. He is responsible for the development and execution of manufacturing systems projects for ACE and serves as a consultant on information security. He has over thirty years of experience as an IT and systems project manager planning and leading control systems, manufacturing systems and business systems projects and teams for DuPont, Koch Industries, ACE and others.

Mr. Sweigart holds degrees in Mechanical Engineering and Computer Science from Penn State and has an MBA from the University of Delaware. He is a member of the MESA Cybersecurity Working Group, a senior member of International Society for Automation (ISA) and a member of the ISPE GAMP Special Interest Group for MES. He is a Certified Information Systems Security Professional (CISSP) and teaches Industrial Control Systems and Cybersecurity courses in the graduate program at Wilmington University.

Panelists:

Byron Hayes, P.Eng.; Grantek

Bryon Hayes, P.Eng. is an Industry 4.0 Consultant at Grantek. He has over 20 years of experience working within the life sciences industry. At Grantek, he is responsible for delivering high quality outcomes for pharmaceutical manufacturers by leveraging his technical and industry expertise, unlocking quality and efficiency gains through the implementation of modern technologies.

Bryon has been an active member of ISPE since 2009. Within ISPE, he is involved in the Pharma 4.0 Community of Practice and was an author of the Pharma 4.0 Baseline Guide and participates in both the Holistic Digital Enablement and the Continued Process Verification working groups. He has been on the ISPE Canada Affiliate board of directors since 2022.

Within Grantek, he developed a 21 CFR Part 11 and Data Integrity assessment and remediation practice and has supported the delivery of this service to multiple customers. He also presented it to the community at large within the ISPE Canada Affiliate in 2019.

Michael Lansasa; Merck

Michael is a dynamic change agent with extensive experience in Quality, Engineering, and Operations within the Biotechnology, Pharmaceutical, and Medical Device industries. He currently serves as the Associate Director of Global Quality Compliance at Merck, where he is responsible for modernizing and streamlining legacy Quality Management Systems (QMS) and implementing digital solutions for Commissioning, Qualification, and Validation (CQV) processes and CMMS.

His expertise spans quality systems, regulatory inspections, strategic planning, plant design, process and equipment validations, technology transfer, and aseptic processing. He has also been instrumental in developing and revitalizing large-scale facilities' infrastructure, processes, technology, to maximize results in the US and international sites. Michael's professional journey includes significant roles at Jacobs Engineering, Integra LifeSciences, and Tengion, Inc., and ValSource, where he managed and executed numerous high-profile large capital projects, including the development of global operations strategies, and compliance improvement projects. Michael holds a BS in Mechanical Engineering from Drexel University.

John Niziolek; IPS

Mr. Niziolek is an innovative and creative professional with over 20 years of management and working experience in commissioning, qualification and validation of pharmaceutical, laboratory, clinical and research and development facilities. His experience includes strategic and practical application of regulatory principles for computerized systems, data integrity, infrastructure, cloud computing, equipment, production controls, and automaton platforms for clients.

His regulation and standards knowledge include 21 CFR Part 210, 211,11, 820; 27 CFR; 40 CFR, USP 1058; EudraLex Volume 4 Annex 11; NUPIC; ISO 13485, 27001; SOX; EN 285; GAMP; cGxP; ASTM E-2500-07 (C&Q); Milspec; DOD; HIPAA; Joint Commission; FedRamp and GDPR.

At IPS, John is responsible for the development and growth of the computer systems validation (CSV), data integrity (DI) and medical gases practices. John’s deep understanding of regulated industry and application of regulatory guidance fosters corporate credibility and ensures defensible, compliant project outcomes.

Registration Information:

"WALK-INs" will be accepted the night of the event, with a $20 surcharge per ticket type (PayPal, cash and credit card will be accepted).

Register now!