Tag

Regulatory Compliance

Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery
LIFE SCIENCES

Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery

Evaluating the effects of new regulations on the medical device sector
Providing guidance on creating and deploying efficient quality management systems
Examining the careful balance between innovation and safety mandates
Sharing approaches for conducting quality risk assessments and taking proactive measures
Charting a future course for the medical device industry with best practices and learned insights

Continue reading
Panel: Planning for Medical Device Manufacturing of the Future: What are the Five Big Things We Need to Talk About?
LIFE SCIENCES

Panel: Planning for Medical Device Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

Innovation and R&D: Fueling our industry, R&D drives groundbreaking solutions. We will explore strategies to stay ahead in technology and product development

Manufacturing Processes and the Future: Optimizing processes for agility and sustainability is key. We adapt to innovations to lead the industry forward

Quality in the Age of AI/ML: Exploring the future of medical device manufacturing and how automation will reshape operations while maintaining quality standards and leveraging technologies for risk mitigation and improvement

Regulatory Compliance: Employing effective strategies for clearance and ongoing compliance

Supply Chain Resilience and Sustainability: Enhancing supply chain resilience and sustainability through strategies that leverage digitization and AI to bolster efficiency, traceability and fortify against unforeseen challenges

Continue reading
Accelerating the Pace of Progress for Innovative Biologic Products
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Accelerating the Pace of Progress for Innovative Biologic Products

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Continue reading
Emerging Trends Impacting Technical Development and Manufacturing
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Emerging Trends Impacting Technical Development and Manufacturing

Jamie Moore is currently Senior Vice President of Technical Development responsible for the CMC development of drug substance and drug product for Gilead’s pharmaceutical and biologic product portfolio. She has over 20 years of experience as a chemist and pharmaceutical scientist working in both large and small Biopharmaceutical companies including CytomX and Roche. At CytomX, she was Senior Vice President on the executive team leading the Protein and Process Sciences, and Manufacturing organizations. Previously she spent a significant portion of her career at Genentech/Roche where she held multiple technical and managerial leadership roles within Pharma Technical Operations including Head of Pharmaceutical Development and Global Head of Manufacturing Science and Technology for Commercial Products. Externally, Jamie is serving as the President- for the Board of Directors for CASSS, an organization that brings together industry, academic and regulatory leaders to resolve scientific challenges impacting CMC development and regulation. She has a B.S. in Chemistry and received her doctoral degree in Chemistry and Chemical Biology from UCSF.

Continue reading
The Ctrl-Alt-Speech Podcast — A Conversation with Mike Masnick and Ben Whitelaw
TECHNOLOGY, VIDEO, PODCAST

The Ctrl-Alt-Speech Podcast — A Conversation with Mike Masnick and Ben Whitelaw

There is a podcast Executive Platforms would like to bring to the attention of our network of senior executives. For everyone interested in online speech, especially issues like trust and safety, content moderation, regulations and compliance, and how technology is changing the way people engage with one another, we recommend the Ctrl-Alt-Speech Podcast co-hosted by Techdirt’s Mike Masnick and Everything in Moderation’s Ben Whitelaw. In this episode we talk about how the podcast came to be, what it hopes to do to help people navigate the evolving landscape of online speech, and what business leaders especially should be thinking about and learning about to prepare their organizations for a new and changing reality, with all that means for the future of commerce. For all this and more, give this episode a listen!

Continue reading
Contract Manufacturing as an Enterprise Capability Multiplier When Strategically Managed
FOOD MANUFACTURING, VIDEO, MANUFACTURING

Contract Manufacturing as an Enterprise Capability Multiplier When Strategically Managed

Tanya Peterson is an accomplished executive with a proven track record in driving operational excellence and fostering strategic partnerships in the consumer goods industry. As the Vice President of External Manufacturing at Mondelez International, she plays a pivotal role in overseeing the company’s external manufacturing operations in North America. With over two decades of experience in supply chain management, Tanya has honed her expertise in optimizing manufacturing processes, ensuring product quality, and maximizing efficiency across diverse production networks. Her commitment to innovation and continuous improvement has led to significant cost savings and enhanced productivity within Mondelez’s external manufacturing ecosystem. Tanya is recognized for her strong leadership skills and ability to build collaborative relationships with external partners, suppliers, and internal stakeholders. Under her guidance, Mondelez has strengthened its global manufacturing capabilities, enabling the company to meet evolving consumer demands while maintaining the highest standards of quality and safety. Prior to joining Mondelez, Tanya held various leadership positions in supply chain management at Danone & Georgia Pacific, where she spearheaded initiatives to streamline operations and drive business growth. She holds a Bachelor’s degree in Mechanical Engineering & a Master’s Degree in Chemical Engineering from Canadian universities, along with an MBA from Portland State University. She continues to stay abreast of emerging trends and best practices in manufacturing and supply chain management. As Vice President of External Manufacturing at Mondelez, Tanya Peterson continues to leverage her expertise and vision to drive sustainable growth and innovation, further solidifying Mondelez’s position as a global leader in the consumer goods sector.

Continue reading
Fireside Chat: Advancing Food Safety: Leveraging Technology and Leadership in the Evolving Landscape
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Fireside Chat: Advancing Food Safety: Leveraging Technology and Leadership in the Evolving Landscape

In his role as the Vice President of Corporate Food Technology and Regulatory Compliance for The Kroger Company, Cincinnati, OH. Howard has the overall strategic responsibility and direction for food safety, quality assurance and product development for the entire Kroger company, this includes approximately 2500 retail stores, 42 Warehouses, and Kroger’s 32 own manufacturing facilities – Dairy, Bakery, Pet Food and Grocery plants. Prior to joining Kroger, he led product integrity and regulatory compliance functions as Vice President at Topco Associates – a private label procurement company in Elk Grove Village, IL.

Howard is the co-chair of the steering committee of global food safety initiative (GFSI), he has over 25 years of experience in the food industry with 18 of those in executive leadership roles, he started his career with the United Nations and he has had the opportunity to work at several food companies and in progressive food safety and quality functions including US Foods, Nestle, Kraft and Darigold, Howard is a food microbiologist by training and has advanced degrees in Integrated supply chain management from Michigan State University.

Continue reading
FDA Regulatory Update: New Era of Smarter Food Safety – A Progress Report
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

FDA Regulatory Update: New Era of Smarter Food Safety – A Progress Report

Mark Moorman is the Senior Science Advisor to Human Foods Program leadership at the Food and Drug Administration. In this role Mark drives prevention efforts with stakeholders to assure the safety of our food supply. Mark previously was the Office Director for the Office of Food Safety and prior to joining the FDA, Mark was the Senior Director of Global Scientific & Regulatory Affairs for the Kellogg Company. Prior to joining the Kellogg Company in 1998, Mark spent 10 years with Silliker Laboratories as the Technical Director of Microbiology. Mark has his undergraduate and Ph.D. degrees from Michigan State University in Microbiology and Food Science.

Continue reading
Fireside Chat: Navigating Technological Advancements, Global Operations, and Supply Chain Innovation
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Fireside Chat: Navigating Technological Advancements, Global Operations, and Supply Chain Innovation

Craig Beasley joined BlueRock Therapeutics in August 2021. As Chief Technology Officer he is responsible for Technical Operations including cell line derivation, process development, manufacturing, facilities and engineering, lab operations, and analytical sciences.

Prior to BlueRock, Craig served as VP, Cell Therapy Supply Chain and Patient Operations at BMS overseeing cell therapy assets (clinical and commercial stage), demand and supply planning, patient operations, external manufacturing oversight (including oversight for lentiviral vector manufacturing), materials management, cell logistics and Cell Therapy’s Business Process owners.

Craig joined Juno Therapeutics in 2016 as head of manufacturing & supply chain.

Prior to that Craig was VP, Next Generation Manufacturing at Biogen, holding leadership positions throughout the technical operations group. Craig started Biogen leading the Process & Automation engineering group and then transferred to the Director of Manufacturing for Biogen’s RTP large scale manufacturing facility. Further to that, Craig served as head of Supply Chain Quality and in addition, worked as Vice President of Financial Planning and Analysis for 2 years reporting to the CFO.

Craig holds a B.S. in Chemical Engineering from Purdue University.

Continue reading
Conquering Complexity: Scaling ESG Reporting in the New Regulatory Landscape
Sustainability, VIDEO, SUSTAINABILITY

Conquering Complexity: Scaling ESG Reporting in the New Regulatory Landscape

Nicole Peerless is Head of Business Engagement at Pulsora, managing all aspects of business engagement for prospective and existing clients, partnerships, and marketing. Nicole joined Pulsora’s leadership team with over fifteen years experience in the investment industry, both in private equity and leading the Investors Industry at the World Economic Forum. While at WEF, she spearheaded the ESG in private markets activities and led a global team overseeing the Forum’s community of asset owners and fund managers.

Continue reading
Accelerating the Pace of Progress for Innovative Biologic Products
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Accelerating the Pace of Progress for Innovative Biologic Products

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Continue reading
Harnessing Big Data for Enhanced Food Safety and Quality in the Digital Age
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Harnessing Big Data for Enhanced Food Safety and Quality in the Digital Age

In his role as the Vice President of Corporate Food Technology and Regulatory Compliance for The Kroger Company, Cincinnati, OH. Howard has the overall strategic responsibility and direction for food safety, quality assurance and product development for the entire Kroger company, this includes approximately 2500 retail stores, 42 Warehouses, and Kroger’s 32 own manufacturing facilities – Dairy, Bakery, Pet Food and Grocery plants. Prior to joining Kroger, he led product integrity and regulatory compliance functions as Vice President at Topco Associates – a private label procurement company in Elk Grove Village, IL.

Continue reading
Panel: Understanding the Interconnected Ecosystem of Food Quality, Regulatory, and Safety
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Panel: Understanding the Interconnected Ecosystem of Food Quality, Regulatory, and Safety

Recorded at NAFS23, in this panel we discuss the interconnected ecosystem of food quality, regulatory, and safety.

Beginning with an overview of the current state of food quality, regulatory and safety ecosystem, then continuing with a discussion of the interplay and evolution of regulatory frameworks, and consumers wants and needs before moving onto an examination of the role of technology, collaboration and education in the quality assurance and food safety systems. Give this one a listen!

Continue reading
Reshaping the Process: How to Enhance Food Safety & Quality through Performance Metrics and Digital Transformations
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Reshaping the Process: How to Enhance Food Safety & Quality through Performance Metrics and Digital Transformations

Spir is currently serving as Vice President, Food Safety, Quality and Technical Services for processed meats, further processed poultry, fresh poultry, fresh pork at Maple Leaf Foods (MLF).  As overall leader of this function Spir is accountable for the strategic direction to deliver on MLF’s Food Safety & Quality (FS&Q) strategy, Food Safety Promise, Quality Vision, day-to-day operations of the FS&Q Management Systems and Microbiology and Chemistry labs that service all MLF’s plants.

Spir began her professional career at Unilever Canada, one of the world’s largest CPG company. She progressed through various roles that included food scientist, sales representative, brand manager, innovation manager, R&D/QA manager, Canada and customer activation manager, North America. During this time, Spir achieved two prestigious Global Innovation Awards for innovative concepts and successful execution. Throughout this time her efforts on the commercial side of the business enhanced her appreciation of the importance of innovation, and customer-centric focus.

Continue reading
Keeping Efficiency and Environmental Sustainability at the Heart of Supply Chain Operations
VIDEO, SUPPLY CHAIN, SUPPLY CHAIN — EUROPE

Keeping Efficiency and Environmental Sustainability at the Heart of Supply Chain Operations

Lelwyn Dsouza has been at Ecolab for 8 years. They are responsible for the roles of Senior Vice President Supply Chain Europe leading the end to end SC for Western Europe, Central Eastern Europe and Russia. This includes ownership of end to end P&L responsibility including safety, Quality, Procurement, planning, Manufacturing, logistics, engineering, other functional disciplines and Supply Chain VP’s who are aligned with Divisions.. Prior to Ecolab, he worked at Procter & Gamble and at Novartis/Ciba-Geigy with a total 33 years of work experience . He is a Mechanical Engineer with a Post graduate Diploma in Business management.

Continue reading
Fireside Chat: Innovating While Navigating a Complex Global Regulatory Landscape
TECHNOLOGY, VIDEO

Fireside Chat: Innovating While Navigating a Complex Global Regulatory Landscape

Cari Benn is Microsoft’s Assistant Chief Privacy Officer and is a leader in global privacy and data protection strategy. She is passionate about building a strong privacy culture that drives responsible innovation and respectful data use. Cari focuses on Microsoft’s strategy for advancing privacy in artificial intelligence, enterprise cloud and consumer services, and emerging technologies that underpin the world’s digital transformation.

Continue reading
Quality and Compliance from the Regulators’ Perspective
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Quality and Compliance from the Regulators’ Perspective

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Continue reading