Tag

Regulatory Compliance

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

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.

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

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.

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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

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

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.

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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

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!

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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

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.

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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

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.

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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

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.

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

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.

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The Post-Pandemic FDA, Cell & Gene Therapy Updates, and Other Industry News — A Conversation with Teresa Gorecki of Compliance Architects LLC
LIFE SCIENCES, LIFE SCIENCES, VIDEO, PODCAST

The Post-Pandemic FDA, Cell & Gene Therapy Updates, and Other Industry News — A Conversation with Teresa Gorecki of Compliance Architects LLC

At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Teresa Gorecki of Compliance Architects LLC about what pharmaceutical manufacturers should expect from regulators as the pandemic winds down, where we are and where we’re going as the pipeline of Cell & Gene Therapies marches towards commercialization, and a wide range of other industry issues, challenges, and opportunities. This is a great conversation that speaks to a lot of key points of interest for pharmaceutical manufacturers of all shapes and sizes. Give it a listen!

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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

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

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

 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

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

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

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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