Tag

Compliance

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.

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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.

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The Triple Bottom Line: Balancing Economic, Social, and Environmental Goals in Food Production
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

The Triple Bottom Line: Balancing Economic, Social, and Environmental Goals in Food Production

Liz Duffy is a seasoned compliance and food safety leader with more than 20 years of experience leading teams to develop and implement comprehensive compliance programs that prioritize food safety and ethical business practices.

Liz began her career at Walmart in 2006 and now serves as Vice President, Global Food Safety & Compliance for the Fortune 1 retailer. In this role, Liz leads the team that supports Walmart’s approach that enables an end-to-end food safety and compliance program and culture. Liz recently transitioned from her previous role as Vice President, Global Omnichannel and eCommerce Compliance at Walmart, where she was responsible for compliance strategy, controls, and continuous improvement processes for the company’s eCommerce, Walmart Business, and Online Pickup and Delivery business offerings.

Liz’s passion lies with food safety, having started her career at Walmart as a Food Safety Manager for Walmart U.S. Stores and Sam’s Clubs. Throughout her nearly two-decade tenure at Walmart, Liz served in a wide variety of compliance roles supporting food safety program development, recall execution, store operations, eCommerce, and omnichannel compliance program acceleration.

Prior to joining Walmart, Liz worked at Cargill Value Added Meats where she supported role in Quality Assurance at a poultry processing facility in Arkansas.

A graduate from the University of Arkansas, Liz holds a Bachelor of Science and an MBA with a focus on Leadership and Ethics. Liz and her family reside in Northwest Arkansas. On the weekends you can find her spending time with her family and her horse.

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Perpetual Adaptation: ​Being Prepared for the Unexpected
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Perpetual Adaptation: ​Being Prepared for the Unexpected

Mahir is a Master in Chemical Engineering from Indian Institute of Technology, Delhi and currently is a Vice President at PepsiCo leading Global FSQA (Food Safety and Quality Assurance) Organization based in New York.

Mahir has four years of work experience in Unilever, India and then 28+ years of experience with PepsiCo. He has worked in Supply chain operations, EHS (Environment , Health and Safety) , R&D, Digitization and most of all in Food Safety and Quality Assurance across three continents – India, Dubai and USA. He is currently responsible for formulating and implementing strategic plans for all Food Safety and Quality initiatives across the entire product portfolio ( Snacks, beverages, Dairy, Bread and meat snacks in over 1300 company-owned and third-party manufacturing sites around the globe.

With deep-rooted knowledge across product categories and differing regulatory and cultural environments, he plays a pivotal role in establishing rigorous standards and systems. He has shared countless lessons learned during his career. His innovative approaches ensure that PepsiCo consistently delivers products that not only meet stringent safety guidelines but also resonate with consumer expectations and satisfaction. Under Mahir’s guidance, the company’s commitment to food safety, quality assurance, compliance, and consumer trust remains unparalleled.

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Shaping the Future: Strategic Insights for Ensuring Food Safety and Quality Excellence in the Years Ahead
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Shaping the Future: Strategic Insights for Ensuring Food Safety and Quality Excellence in the Years Ahead

Jorge Hernandez is the Vice President of Quality Assurance for the Wendy’s Company. As such, he is responsible for the design, implementation and leadership of the Food Safety, Quality Assurance and Regulatory Compliance Programs that impact suppliers, distribution centers and 7,250 restaurants in 33 Countries.

Previously, Jorge was the Chief Food Safety Officer at Wholesome International; he also served as the Sr. VP of Food Safety and Quality Assurance at US Foods Foodservice Distributor; and the VP of Food Safety and Risk Management at the National Restaurant Association.

Jorge has Degrees in Biology from Rockford University, Microbiology from the Centro de Estudios Medico-Biologicos in Mexico City, Mexico, Languages and Literature from la Universite de la Sorbonne, Paris, France and Executive Leadership from the Said School of Business at Oxford University in Oxford, England.

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Transparency and Collaboration as a Competitive Edge: Earning Consumer Trust Through Visible and Controlled Supply Chains
Uncategorized

Transparency and Collaboration as a Competitive Edge: Earning Consumer Trust Through Visible and Controlled Supply Chains

Sara Mortimore is the former Vice President and Global Subject Matter Expert for Food Safety at Walmart Inc. In this role, Sara was responsible for the global development and oversight of all Food Safety programs and initiatives for the company’s more than 10,500 stores, manufacturing facilities, distribution, and fulfilment centers. A proud accomplishment was leading the team to be awarded the IAFP Black Pearl Award in 2024.

Prior to joining Walmart in May 2019, Sara held the position of Vice President of Product Safety, Quality and Regulatory Affairs with enterprise-wide responsibility at Land O’Lakes, Inc. In this capacity, she covered both human and animal foods and supported non-profit international development work.

Sara began her career with Glaxo SmithKline as a Research Technologist in Research & Development. In 1989, she joined Grand Metropolitan Foods, which later became Pillsbury and was subsequently incorporated by General Mills Inc. Here she led food safety, quality, and regulatory teams throughout international markets, including support of brands such as Haagen Dazs, Wanchai Ferry, Old El Paso, and Green Giant.

She is the co-author of several successful books, chapters and papers on HACCP and food safety management. Sara has served on the board of trustees for the Royal Society of Public Health, for the BRC International Advisory Board, and is a past member of the Global Food Safety Initiative Steering Committee.

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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.

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Panel: Empowering Women in FSQA Leadership
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Panel: Empowering Women in FSQA Leadership

Explore strategies for attracting, developing, and retaining the next generation of female professionals in food safety and quality, essential for current and future success
Examine the unique obstacles women face in the food safety and quality sector and identify opportunities for professional growth and leadership advancement
Develop impactful strategies to foster organizational growth while nurturing a diverse and inclusive workforce
Share examples of successful mentorship initiatives, including onboarding, cross-training, job shadowing, and continuing education, that support and advance women’s careers in food safety and quality

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The Art and Science of Leading Organizations in a Rapidly Evolving Global Food Safety and Quality Environment
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY

The Art and Science of Leading Organizations in a Rapidly Evolving Global Food Safety and Quality Environment

A recognized expert in food safety and quality, Catherine vigorously pursues quality systems excellence across the supply chain. Catherine is an experienced leader in Food Safety, Quality Systems, Quality Programs, and Laboratory Management. She builds followership and high performing cross-functional teams, finds effective solutions to continuously keep food safety and quality food manufacturing and delivery top of mind for all stakeholders, and inspires teams to strive for top tier execution.

Currently, Catherine is Vice President of Quality, Safety, Health and Environment at Sabra, America’s most iconic and beloved hummus. At Sabra, Catherine enabled an end-to-end transformation in food production and delivery, intensifying and expanding a culture of people and food safety across the organization and developing a best-in-class food safety and quality program.

Prior to joining Sabra, Catherine worked at Dairy Farmers of America and Kerry in food safety, quality systems and quality control innovation. Catherine holds a Bachelor of Sciences degrees in biotechnology and food science and a Master of Science degree in food microbiology from Oklahoma State University.

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Panel: Harmonizing Quality and Safety Excellence Across the Food Ecosystem: Perspectives from Retail, Foodservice, Restaurants & Manufacturers
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Panel: Harmonizing Quality and Safety Excellence Across the Food Ecosystem: Perspectives from Retail, Foodservice, Restaurants & Manufacturers

Overview of the current industry of food quality, regulatory and safety ecosystem and the interplay and evolution of regulatory frameworks, and consumers wants and needs
The alignment of quality standards and the strategies employed to ensure consistent quality standards across various in house and purchase brands
Exploring how to work closely with external suppliers to align their practices with our company’s stringent quality requirements
Examining the role of technology, collaboration and education in the quality assurance and food safety systems of the future

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Quality is Not Just a Cost Center: Proving the Value of Quality and Safety Initiatives with Data
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Quality is Not Just a Cost Center: Proving the Value of Quality and Safety Initiatives with Data

Quality and Safety teams often struggle to secure budget priority despite their essential roles. Learn how to shift that narrative with actionable strategies and data-driven insights
This session will explore how building a strong, data-driven continuous improvement program can not only reduce risk and improve safety but can also help teams paint a clearer picture of the value they create for their brand
Gain insights on how to put continuous improvement data to work for your organization

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Experiences and Expectations of Leaders in Applying Digital Transformation to Food Safety
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

Experiences and Expectations of Leaders in Applying Digital Transformation to Food Safety

Learn from experienced industry leaders as they discuss how digital transformation has improved food safety and quality management
Gain valuable insight into overall organizational and end user experiences with the implementation of new digital solutions
Explore what the future holds and the full potential of digital transformation, including artificial intelligence, for the food and beverage industry

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From Coding to Configuring Solutions: Elevating Transparency, Traceability, and Governance with Zero Code Technology
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY

From Coding to Configuring Solutions: Elevating Transparency, Traceability, and Governance with Zero Code Technology

Shan has an Engineering Degree from University of Madras, India and an Executive MBA from Georgia Tech, USA. He has over 25 years of Engineering, IT, and SCM consulting experience with many Global leaders in Retail, Manufacturing, FMCG, Groceries, Pharmaceuticals and Distribution, and few Big 5 consulting companies and few Top Gartner Magic Quadrant leaders in ERP, Supply Chain Management and Master Data Management Software.

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The People-Led, Tech-Powered Future of Cybersecurity
TECHNOLOGY, VIDEO

The People-Led, Tech-Powered Future of Cybersecurity

Jason O’Dell is Walmart’s Global Vice President of Security Operations. He is a seasoned executive with 25+ years of security experience in multiple domains. In his current role, Jason is entrusted with safeguarding Fortune 1, its 250+ million weekly customers, and its 2.1 million associates from ever-growing cyber threats.

Prior to leading the teams responsible for protecting Walmart’s network, Jason successfully led a Managed Security Service Provider (MSSP) that provided protection to more than 1,000 financial institutions, collectively holding assets worth over $500 billion. Under his guidance, the MSSP received accolades as a top 50 world-ranked provider for five consecutive years.

Jason holds a BS degree in Cybersecurity from Bellevue. He has been quoted in various national media outlets, holds over a dozen industry certifications, and has held multiple board level positions at various information security chapters. His work and dedication in the field of information security was acknowledged by the SANs Institute, which honored him with the Difference Maker Award. Outside of work, Jason is a neophyte vinyl collector, a BBQ judge, and an avid reader

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Fireside Chat: Navigating the Future: Scaling Secure AI Amidst Emerging Policies and Privacy Challenges
TECHNOLOGY, VIDEO

Fireside Chat: Navigating the Future: Scaling Secure AI Amidst Emerging Policies and Privacy Challenges

Xochitl Monteon is Intel’s Chief Privacy Officer (CPO) and VP of Cybersecurity Governance, Risk and Compliance in Information Security. As the CPO, Xochitl plays a pivotal role in leading Intel through the complex landscape of global privacy, AI, and cybersecurity legislation to seamlessly operationalize compliance while enabling continued business innovation. Xochitl’s expertise lies in her ability to integrate rigorous privacy policies with robust cybersecurity frameworks, fostering a secure and compliant digital environment. Her leadership is characterized by a proactive approach to emerging threats and vulnerabilities, ensuring that privacy and security considerations are at the forefront of corporate governance.

Xochitl has worked in the technology industry for 30 years. Prior to joining Intel, she worked for McAfee and PayPal in Senior leadership positions. Her tenure includes pivotal roles in a wide array of sectors such as high-tech manufacturing, SaaS, fintech, e-commerce, finance, biotechnology, pharmaceuticals, education, and the broader technology landscape.

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Endpoint Strategies to Achieve Cybersecurity Compliance — A Conversation with Romanus Prabhu of ManageEngine
TECHNOLOGY, VIDEO, PODCAST

Endpoint Strategies to Achieve Cybersecurity Compliance — A Conversation with Romanus Prabhu of ManageEngine

In the run-up to the 2024 edition of the North American Information Security Summit we spoke with security evangelist Romanus Prabhu of Manage Engine about how data security and cybersecurity professionals need to rethink and reevaluate their systems to account for new threats. The reality is protection can never get in the way businesses operate, so what is the right balance to strike between proactive methods, employee engagement, and resiliency versus functionality and productivity? What mindset do security leaders need to have? How should they be looking at their tools, tactics, and technologies? For all this and more, give this episode a listen!

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Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy

Anil Sawant is Senior Vice President, Global Quality Compliance at Merck. He is a healthcare Executive with over 35 years of operations experience in Quality Operations, Ethics & Compliance, Research Integrity and Auditing functions. A strategic thinker experienced in development and deployment of management controls, governance processes, and quality and compliance systems in diverse business environments and cultures. Anil leads groups managing branded and generic products, small molecules, vaccines, bio-pharmaceutical, medical devices and consumer products. He was part of the teams that commercialized the first antibody-drug conjugate product and first photoactive drug. Expertise in interpretation of GMPs, GLPs, and GCPs. Good understanding of SOX, Anti-Kickback, Anti-Trust, Privacy and FCPA. Skilled crisis manager and pragmatic thinker with excellent understanding of regulatory requirements, global pharmaceutical supply chain and R&D operations. Extensive experience in resolving compliance matters with US FDA and international regulatory agencies. Subject matter expert in pharmaceutical microbiology and aseptic processing.

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