Navigating the Future of Pharma: Global Regulatory & Supply Chain Forum
As global supply chains grow increasingly complex and regulatory scrutiny intensifies, staying ahead of compliance is no longer optional—it’s a strategic necessity.
On April 7th, 2026, join an elite group of regulatory experts and quality assurance professionals for a full day of high-impact learning. This forum is designed to bridge the gap between emerging global regulations and practical operational excellence, providing the tools needed to maintain resilience in a volatile market.
Registration Fees & Deadlines
Member $45 | Nonmember $75 | Student $25
Why Attend?
This event provides a 360-degree view of the pharmaceutical and device lifecycle—from raw materials to complex Biologics and Combination Products. You will gain direct insights into the trends shaping the industry:
- Global Perspectives: Gain the latest updates on global regulatory shifts and supply chain trends impacting the 2026–2028 term.
- Technical Deep Dives: Explore Good Distribution Practices (GDP) for APIs and finished products, alongside the complex analytical journey of Biologics.
- Guidance on Combo-Devices: Navigate the intricate rules and regulations governing medical device combinations and their integration into the pharma space.
- Risk Mitigation: Identify common audit non-conformances, GMP requirements, and legal risks before they impact your business.
Learning Objectives
- Analyze the impact of current global regulatory updates on manufacturing and distribution standards.
- Evaluate compliance strategies for GDP across the entire supply chain, from raw materials to finished pharma products.
- Navigate the evolving regulatory framework for Combination Medical Devices in domestic and international markets.
- Identify common audit pitfalls and legal risks to improve organizational "audit readiness."
- Assess technical requirements specific to the development and scaling of Biologic drugs.
Agenda
8:30-9:30 am Registration & Breakfast
09:30-10:30 Session 1
Welcome & RAPS Global Regulatory Update, Heinz Steneberg, MDSS
Global Regulatory Supply Chain Update, Hank Karayan, Head of Pharma & Cosmetics, SGS
APIs, Finished Pharma Product, Storage & Distribution (GDP), Jon Gawlak, Technical Manager/Senior Auditor, SGS
10:30-10:45 Break
10:45-12:15 Session 2
EXCiPACT GMP & PAMs Update, Iain Moore, Senior Advisor Operations, IPEC
Combo Device Rules & Regulations Update, Mingxiang Xu, Technical Director, Medical Devices, SGS
Panel Discussion (Speakers from Session 1 & 2)
12:15-1:00 Lunch
1:00-2:30 Session 3
Customer Perspective on Combo-Medical Devices, James Wabby, Head of Global Regulatory Affairs, AbbVie & Adjunct Assistant Professor, USC, School of Pharmacy – Regulatory and Quality Sciences
Audit Risks & Common Non-Conformances in the Pharmaceutical Supply Chain, Jon Gawlak, Technical Manager/Senior Auditor, SGS
Analytical Journey of Biologics Drugs, Greg Adams, Head of Biopharma Science, SGS
2:30-2:45 Break
2:45-4:00 Session 4
Legal Update in the Pharmaceutical Industry,
Supply Chain Risks & Solutions, Jon Gawlak, Technical Manager/Senior Auditor, SGS
Panel Discussion (Speakers from Session 3 & 4)
4:00-6:00 pm Reception/Happy Hour
Speakers
Heinz Steneberg is a seasoned professional with over 25 years of experience in the medical device and diagnostic industries. Throughout his extensive career, he has held roles in Regulatory Affairs, Quality Assurance, and Clinical Affairs. He has led many successful regulatory submission projects, including IDEs, PMAs, 510(k)s, and EU MDR & IVDR dossiers, as well as submissions to regulatory agencies in Asia and South America. He served as the management representative and as the Person Responsible for Regulatory Compliance (PRRC).
With a unique perspective gained from leadership roles, including VP of Regulatory Affairs at MTL, Executive Director of Regulatory and Quality Management at Quest Diagnostics, Head of Regulatory and Clinical at Carl Zeiss Meditec, and Director of Regulatory Affairs at Roche Molecular Diagnostics, as well as his foundational experience as a Division Manager at TUV Rheinland of North America's Medical Division, he is well positioned to offer clients the strategic advice needed to navigate product approvals and market access.
His passion is to work with innovative companies to accelerate the development of new medical and diagnostic solutions for patients.
Greg Adams
Head of Biopharma Science at SGS North America
Greg Adams is the Head of Biopharma Science at SGS North America (based in Apex, NC). He is a senior analytical development leader specializing in biologics, with over 28 years of experience driving successful IND-to-BLA submissions, protein analytics, and global strategies in the biopharmaceutical industry. His expertise includes characterization of protein-based biopharmaceuticals. He has prior experience at organizations such as FUJIFILM Diosynth Biotechnologies and others in the sector, focusing on enhancing service offerings, analytical method development, and achieving FDA approvals.
Jon Gawlak
Technical Manager/Senior Auditor, SGS North America
Over 35 years of Quality and Project Management Experience with over 29 years of Leadership Experience in the Pharmaceutical, Cosmetic, Personal Care, Food, and Medical Device Industry
Specialties: QA, QC, Supplier Qualification and Management, CMC, Quality Management, Project Management, Certification Auditing, Vendor Auditing, Internal Auditing, Analytical Testing, QC Laboratory Management
Mingxiang Xu
Technical Director, SGS North America
Mingxiang (Ming) Xu began his professional journey over 31 years ago, building on a multidisciplinary foundation in science, engineering, and business. His career spans a diverse range of industries, including scientific research, electronic manufacturing, information technology, alternative energy, and medical devices.
Ming currently serves as Technical Director at SGS North America, where he supports clients in meeting the requirements of the EU MDR, MDD, and UK MDR. A prolific reviewer of both active (including software) and non-active medical devices, he works across Class lla to Class III product categories. He is also recognized as a subject matter expert in devices without an intended medical purpose (Annex XVI) and drug-device combination products (Article 117).
Earlier in his R&D career, Ming contributed to the development of medical devices such as infusion systems, electrosurgical units, and endoscopic imaging technologies. His broader technical expertise also includes ultrasonic imaging, electromagnetic navigation, irreversible electroporation, ultrasonic surgical instruments, surgical robotics, electrohydraulic lithotripsy systems, endoscopic balloon catheters, introducers, guidewires, tissue acquisition and apposition tools, and sealing solutions. He holds multiple U.S. patents, most of which relate to innovations in medical technology.
Jessica holds a master’s in jurisprudence in Health Law from Seton Hall University and B.S. in Biomedical Engineering from Rutgers University. She has held various roles in Quality and Engineering within the Pharma and Biologics industries. She started her career at BASF in Sep 2011 as Quality Management Specialist for the North America region, gaining experiences in various quality realms and represented BASF’s Quality interests in various trade organizations (i.e., IPEC Americas, ASQ, etc.)
Jessica is now a Quality Compliance Manager for BASF Global Quality Governance. She is an America Society of Quality (ASQ) Certified Quality Auditor. As a member of IPEC America, she functions as the lead for the Education Strategy team and serve as an active contributing member for the GMP, Excipient Qualification, and QbD committees.
Hank Karayan
Global Head of Cosmetics and Pharma Assurance, Global FSMA Program Director
Hank Karayan is Global FSMA Program Director and Global Head of Cosmetics and Pharma Assurance at SGS. He began his career as a quality, GMP, food safety, and cosmetics consultant and trainer with a European multinational firm, where he built hands-on experience in strategic management, regulatory compliance, industry best practices, and Total Quality Management.
He has since led numerous projects for multinational organizations,SME s, and regulatory bodies across multiple geographies. John later transitioned into audit and compliance, specializing in supply-chain risk management, food safety strategy, food defense, information security, and management systems.
He holds a Bachelor of Science in Biology and an MBA, and is the author of multiple publications on food safety, food defense, FSMA, and strategic management.
Location
Crowne Plaza Foster City-San Mateo
1221 Chess Dr
Foster City, California 94404
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.