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Regulatory Compliance

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

Conquering Complexity: Scaling ESG Reporting in the New Regulatory Landscape

April 5, 2024

ESG reporting presents a complex challenge for large organizations.  New regulations like the EU’s CSRD and the SEC’s climate disclosure rules raise the bar for transparency and accountability. Effectively managing ESG data, often spread across regions and departments, is critical to meeting these heightened expectations. Building effective ESG governance requires a strategic approach that tackles both data management and regulatory compliance as interconnected aspects of this complex challenge.In this session, you will: Nicole PeerlessHead of Business EngagementPulsora Inc. Nicole Peerless is Head of Business Engagement at Pulsora, managing all aspects of business engagement for prospective and existing clients, partnerships, and…

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

Accelerating the Pace of Progress for Innovative Biologic Products

November 22, 2023

— Peter MarksDirector – Center for Biologics Evaluation and Research (CBER)FDA 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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Harnessing Big Data for Enhanced Food Safety and Quality in the Digital Age
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

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

October 4, 2023

Howard PopoolaVP – Corporate Food Technology and Regulatory ComplianceKroger 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,…

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

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

October 12, 2023

Julie RamseyDirector, FSQAImpossible Foods Julie Ramsey is the Director of FSQA at Impossible Foods. Impossible Foods was founded to transform the global food system and reduce the impact of climate change by making the world’s most delicious, nutritious, and sustainable meat, fish, and dairy — from plants. At Impossible Foods, Julie is responsible for food safety and quality at the manufacturing sites and throughout distribution. Her scope includes creating systems and procedures to ensure successful product launches and manufacturing, product specifications,food safety systems, continual improvement in product quality and performance, and monitoring the product throughout the supply chain. Julie previously…

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

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

October 6, 2023

Spir MarinakisVP of Food Safety, Quality Assurance, Technical Services & SanitationMaple Leaf Foods 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…

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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

July 6, 2023

Integrating sustainability into everyday operations, reducing water and energy use Building partnerships with customers to boost operational efficiency, safety, product quality, and sustainability Collaborating with suppliers and customers to amplify our joint environmental impact Addressing pressing challenges like supply chain transparency, resource scarcity, climate change disruptions, waste management, and regulatory compliance — Lelwyn Dsouza SVP Supply Chain Europe Ecolab 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…

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

Fireside Chat: Innovating While Navigating a Complex Global Regulatory Landscape

June 26, 2023

What do business leaders need to know about the ever-changing landscape of global regulation? The critical role of trust in today’s competitive business environment and changing stakeholder expectations for organizational leaders Updates on the latest developments in AI and understanding the opportunities and considerations for large organizations How can leaders balance potential risks and identify opportunities that come with new regulations Approaches for navigating compliance requirements while continuing to rapidly innovate and leverage the latest advancements in AI — Cari Benn Assistant Chief Privacy Officer Microsoft Cari Benn is Microsoft’s Assistant Chief Privacy Officer and is a leader in global…

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

Quality and Compliance from the Regulators’ Perspective

May 25, 2023

What are regulators looking for when they engage with QA/QC executives and other senior leaders? How can industry facilitate these interactions? Thinking about your processes and facilities from the point of view of the inspector: What are you taking for granted based on familiarity or habit or tradition that would not apply to a fresh pair of eyes? Highlighting best practices to make ongoing documentation a powerful quality and compliance tool for the future Using compliance as a starting point: What does exceeding expectations look like, and how should pharmaceutical manufacturers stay ahead of that moving target in perpetuity? —…

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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence

November 23, 2022

Being part of the solution: Launching two medicines in record time during the pandemic Meeting growing complexity head-on Establishing communities of practitioners to re-imagine manufacturing and process development Re-thinking how we collaborate across boundaries — Susanne Hundsbaek-Pedersen Global Head Pharma of Technical Operations Roche Susanne serves as the Global Head of Pharma Technical Operations at Roche, a global biotech company. Roche delivers long-term and sustainable healthcare solutions to serve millions of patients in 150 countries. Pharma Technical Operations spans the world with sites on four continents and covers the value chain from Technical development, CMC to Commercial supplies. She is…

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Unlocking the Promise of Gene Therapy
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Unlocking the Promise of Gene Therapy

November 28, 2022

Review the current state of gene therapy Discuss overcoming barriers to product development Make the case for global regulatory convergence Describe FDA actions facilitating gene therapy development — Peter Marks Director – Center for Biologics Evaluation and Research (CBER) FDA 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…

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Advancing Pharmaceutical Manufacturing Quality
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Advancing Pharmaceutical Manufacturing Quality

April 8, 2022

 Using innovative thinking to realize a future more “immune” to supply chain disruptions Incentivizing improvements to the pharmaceutical manufacturing infrastructure that enhance the reliability of manufacturing and supply Delivering on the promise of advanced manufacturing to provide reliable, available, high-quality drugs for patients — Michael Kopcha Director, Office of Pharmaceutical Quality, CDER FDA Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise…

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Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy
LIFE SCIENCES

Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy

November 26, 2019

Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing? Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively Bringing a structured approach to your advocacy within your network of industry and trade organization connections Embracing the idea that keeping things simple even in a complex environment generates the best outcomes — Pat Yang Former EVP at Juno Therapeutics, Roche and Genentech Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management…

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Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects

November 25, 2019

At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Jack Garvey, Compliance Architects’ co-founder and CEO. Jack has chaired the Quality stream of content for several Biomanufacturing World Summits, and he has deep insights to offer biopharmaceutical manufacturers looking to communicate with regulators and build their organizations to better address the issues of Compliance, Quality, and Risk. — Jack Garvey CEO Compliance Architects Jack Garvey is the Founder and Chief Executive Officer of Compliance Architects®, a leading consulting and advisory firm specializing in innovative quality and compliance solutions for FDA-regulated…

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Regulator Keynote: Updates, Progress Reports, and Looking Forward to the Future
FOOD SAFETY & QUALITY, VIDEO

Regulator Keynote: Updates, Progress Reports, and Looking Forward to the Future

July 1, 2019

Offering updates on the FDA’s policies and priorities. Sharon Lindan Mayl, J.D. Senior Advisor for Policy, Office of Food Policy and Response FDA Sharon serves as the Senior Advisor for Policy, Office of Food Policy and Response. In this position, she oversees and manages significant policy initiatives related to food safety. She currently focuses on implementation of the FDA Food Safety Modernization Act (FSMA). Ms. Mayl co-leads the team responsible for the FSMA import rules and guidance documents, including those related to the Foreign Supplier Verification Program, Voluntary Qualified Import Program, and Accredited Third-Party Certification Program as well as the…

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