GAMP CoP "GAMP and ISA 95"
Chris Monchinski, chair of the ISA-95 Standard Committee, will present on the important relationship between the ISA-95 Standard on integration between the business systems (ERP) and the control systems and the strong relationship to GAMP principles and guidance.
Unlocking Smart Compliance in Pharma Manufacturing: ISA-95 Meets GAMP 5®
In today’s regulated industries, compliance alone is not enough—efficiency, traceability, and integration are equally vital. ISPE GAMP 5® offers a risk-based approach to developing quality and compliant automated systems, while ISA-95 serves as the global standard for aligning business (ERP) and manufacturing (MES/MOM) systems.
When applied together, these two frameworks create a powerful synergy: enabling smarter system design, streamlined operations, and robust regulatory compliance. This session will explore how combining GAMP’s critical thinking principles with ISA-95’s structured integration model drives excellence in pharmaceutical manufacturing.
Whether you're designing, validating, or operating automated systems in regulated environments, this seminar will give you practical strategies to elevate your approach. If you’re responsible for digital transformation or manufacturing IT in the life sciences, this session is essential.
Moderators:
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.
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.
Presenter:
Chris Monchinski | CTO | InflexionPoint LLC
As the CTO at InflexionPoint, Chris led the charge in empowering clients to revolutionize their manufacturing and operations through the application of cutting-edge digital technologies. Chris' responsibilities span strategy development, forging strategic partnerships, enhancing client engagement, and driving the evolution of our solutions. Chris consultswith key client accounts to enable InflexionPoint clients to achieve their goals in all phases of their digital transformation.
Chris' commitment to the industry extends beyond the boardroom; He is an active member of ISPE and contributes to other key organizations, serving as a member of the Smart Manufacturing Model Committee at MESA and chairing both the MESA Analytics Working Group and Knowledge Committee. His leadership roles include former Vice President of the ISA Standards and Practices Board (2019-2020), Managing Director of the ISA Standards and Practices Board, and Chair of the ISA 95 committee on Enterprise-to-Control System Integration. As the convenor of the IEC/ISO JWG5, Chis oversees the maintenance of the IEC-62264 standards series.
Chris holds a Bachelor of Science in Electrical Engineering and a Master of Science in Computer Science and is also a Certified Automation Professional with ISA.
Registration will open at 5:30 pm and appetizers/drinks (wine and beer) will be served beginning at 5:30 pm; the panel discussion will begin at 6:30 pm and conclude by 8:00 pm.
"WALK-INs" will not be accepted the night of the event
Cancellation Policy: Full refund or credit voucher for a future program will be given up until 7-days before program; After June 4th, no refunds or credit vouchers will be provided.
Schedule of Events:
- 5:00 pm – 6:00 pm: Appetizers, Cocktails, Networking
- 6:00 pm – 7:30 pm: Presentation
- 7:30 pm – 8:00 pm: Socializing & Meeting Adjourned