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San Francisco Bay Area Chapter In Person Event: 2026 Risks with Pharmaceutical & Medical Devices in

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 President & CEO, MDSS USA 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 Nicole Cansler Board Member, EXCiPACT 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 .

RAPS Workshop: Cybersecurity Unauthorized

Securing medical devices and documents for regulatory submissions from cyberattacks is challenging. Many medical device companies struggle to retrofit their security programs to address hardening, vulnerability management, and global incident response. New statutory requirements in the United States are increasing the focus on planned postmarket activities in the submission process. Cybersecurity has become mission-critical for medical device manufacturers. Health authorities spanning the US, European Union, Australia, Canada, and Japan have issued cybersecurity guidance that is essential for regulatory affairs professionals to understand. In addition to premarket concerns, some of the guidance also includes expectations for post-market expectations. This interactive virtual workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations Technical staff will get a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of gaining green lights from regulators while also teaching them how to establish trust with customers concerned about risk related to medical devices on their networks. Registration Fees & Deadlines Present – 7 March 2026: Early Bird Member $865| Nonmember $1020 8 March 2026 – 7 April 2026: Regular Member $1020 | Nonmember $1200 Learning Objectives Thoroughly understand international regulatory expectations for medical device cybersecurity Know the main components of a product security program aligned with global expectations Understand how to use pre-submissions to reduce the likelihood of cybersecurity-related deficiencies Be able to build more successful cybersecurity content for regulatory submissions Learn key medical device security standards Who Should Attend? Early and mid-stage career regulatory and quality professionals through the director level Engineer-level to director-level R&D professionals Audience Learning Level Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities. Agenda Topic 1 Title: An Introduction to Medical Device Cybersecurity Concepts and Challenges Speaker: Michelle Jump Topic 6 Title: Submission Strategies for Cybersecurity Speaker: Matthew Hazelett Topic 2 Title: Medical Device Product Security Programs: Putting together the puzzle Speaker: Michelle Jump Topic 6a Title: IEC 81001-5-1: Foundational Standard for Cybersecurity Speaker: Michelle Jump Topic 3a Title: FDA Select Update, 524B, and Omnibus Speaker: Matthew Hazelett Topic 7 Title: Labeling and Communication Speaker: Michelle Jump Topic 3b Title: eSTAR: Review of the Document Expectations Speaker: Michelle Jump Topic 10 Title: Overview of global regulatory expectations Speaker: Michelle Jump Topic 4 Title: Secure Design: You Can’t Mitigate Your Way to Security Speaker: Matthew Hazelett Topic 11 Title: Postmarket Overview Speaker: Michelle Jump Topic 4b Title: SBOM Speaker: Michelle Jump Topic 12 Title: Threat Intelligence and Incident Response Speaker: Michelle Jump Topic 5 Title: Security Risk Management and Threat Modeling Speaker: Michelle Jump Topic 14 Title: Vulnerability and Patch Management Speaker: Michelle Jump Topic 15 Title: Disclosure and Advisory: When and How Speaker: Michelle Jump Speakers Michelle Jump CEO at MedSec Michelle Jump is the CEO of MedSec, where she is responsible for providing strategic leadership, training, and advisory services to the medical device industry in the area of cybersecurity compliance, global regulations, standards, product security program development, and security risk management. Matthew Hazelett Chief Operating Officer and Chief Quality Officer at MedSec, Former FDA Cybersecurity Policy Analyst Matthew Hazelett is a former cybersecurity policy analyst at the US Food and Drug Administration Center for Devices and Radiological Health Office of Product Evaluation and Quality Clinical and Scientific Policy. Hazelett started at the FDA as a biomedical engineer within the Implantable Electrophysiology Devices Branch at the Center for Devices and Radiological Health (CDRH). His review areas include pacemakers, defibrillators, leads, and supporting devices, such as programmers and home monitors. Since starting at FDA, Hazelett developed a review focus on cybersecurity, participates in cybersecurity guidance development, and supports cybersecurity vulnerability assessments and reviews across CDRH. Hazelett also has worked for a medical device research and development company as a test engineer and test manager overseeing device verification and validation testing. 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 .