GAMP: Digital Transformation in a Regulated Environment

Digital Transformation in a Regulated Environment

What does digital transformation mean? OT systems generate a tremendous amount of data. How can this data - real-time, time-series, event data, data from lab and other systems - be leveraged to accelerate operations, optimize the process, and help run operations better?” Topics covered will include technology and platforms, IT\OT integration, and data governance - for operations as well as development.

Thank you to our sponsors for this event:

Why This Event Matters 

• Digital transformation is a fundamental process changing our industry. Getting it right can mean the different between success and failure.

Who Should Attend

• Anyone associated with, or impacted by, digital transformation efforts – leaders, managers, implementers.

What You'll Learn

• Why digital transformation matters now and what are the Pharma-specific realities.

Key Takeaways 

• Core principles for digital transformation, how to create a transformation roadmap and realize value.

Moderator: 

Dirk Sweigart, PMP, CISSP | Applied Control Engineering, Inc.

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:

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.

Anant Viswanath; GSK

Anant Viswanath is the Digital Lead for Drug Product capital projects at GSK, where he is responsible for delivering smart manufacturing capabilities for a new drug product facility currently under construction. In this role, he leads the implementation of digital solutions including electronic batch records (eBR), SAP enhancements, eChecklists, eLogbooks, digital scheduling, AGVs, and other systems to improve operational efficiency and enable a fully paperless manufacturing environment.

Anant brings a blend of digital, operational, and validation experience in regulated pharmaceutical environments. Prior to his current role, he led the initial eBR deployment in packaging, served as a Packaging Operations Manager, and was the site Validation Manager for several years. His work focuses on the practical application of digital strategies—ensuring alignment between business objectives, validation requirements, and data integrity standards while delivering measurable improvements in manufacturing performance. Anant holds a BS in Chemical Engineering from the University of Birmingham (U.K.) and an MS in Chemical Engineering from Syracuse University.

Arlene M. Weichert; InflexionPoint, LLC

Responsible for the customer experience on large capital projects delivering digital transformation and process automation to leading life science customers. Leads a team of solution architects, automation engineers, and network/cyber specialists that engage with end users and design / construction partners to deliver business benefits, expanded capacity, and optimized operations through solutions including process automation, MES/MOM, and advanced analytics. InflexionPoint solutions use real-time data powered by AI / ML tools to uncover hidden capacity and optimize the process, yield, and quality. Ensure that projects are appropriately resourced and customer relationships are strengthened through meeting expectations and delivering results.

Arlene joined the organization (then known as ACC) in 1990 as a Project Engineer. She built her career helping life science and other manufacturing companies implement technology that improve the capacity, productivity, quality, and compliance of process-oriented operations. She continues to develop relationships with end customers and partners and further the awareness of InflexionPoint and its capabilities. “Customer relationships are the foundation of our business. Our strategy has always been to develop and grow customer relationships by meeting expectations and delivering solutions that provide the ability to effectively run their operations and processes.”

Arlene earned a B.S. in Electrical Engineering in 1987 and a M.S. in Industrial Engineering from in 1990, both from Lehigh University.

Location:

Eastern Controls

3850 Providence Road, Edgmont, PA 19028

Parking:

There is ample, free parking at Eastern Controls.

Registration will open at 5:00 pm; networking and light refreshments until 6:00pm; presentations will begin at 6:00 pm and conclude by 7:30 pm.

Cancellation Policy: Full refund or credit voucher for a future program will be given up until 7-days before program; After July 2nd, no refunds or credit vouchers will be provided. Registration website will close at 2:00 pm on Thursday, July 9th.

"Walk-in" registrations will be allowed with a $20 per ticket surcharge (Cash, Credit Card or PayPal accepted on-site).

Schedule of Events:

• 5:00 pm – 6:00 pm:  Networking and Light Dinner, Beer and Wine
• 6:00 pm – 7:30 pm:  Presentations and Panel Discussion
• 7:30 pm – 8:30 pm:  Networking