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Compliance

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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Practical Considerations for Establishing a Scope 3 Data Collection Strategy
Sustainability, SUSTAINABILITY, VIDEO

Practical Considerations for Establishing a Scope 3 Data Collection Strategy

February 8, 2023

The quest for more accurate Scope 3 GHG Emissions data is more important than ever with the changing regulatory and climate-action landscapes. However, Scope 3 data collection continues to be a challenge despite making up the bulk of most companies’ GHG inventory. Join this workshop to discuss: Best practices on how to take a differentiated approach to Scope 3 data collection and move up the Scope 3 maturity curve The importance of technology in facilitating accurate Scope 3 data collection Lessons learned from real-life Scope 3 programs — Amanda Petzinger Associate VP of ESG/Sustainability Digital Solutions Benchmark ESG Amanda Petzinger,…

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The New Net Zero : Carbon Markets Today and Tomorrow Under Article 6
Sustainability, SUSTAINABILITY, VIDEO

The New Net Zero : Carbon Markets Today and Tomorrow Under Article 6

March 21, 2023

With the historic agreement of Article 6 at COP26 last year and Net Zero commitments now covering over 80% of global emissions, governments will soon join the private sector in buying and selling carbon credits for Net Zero aims. But what does this mean for corporate voluntary commitments going forward? Are these two different markets and ledgers, or are they intertwined? What does this mean for corporate claims and ownership of the carbon credits and what should buyers planning long term purchasing of carbon credits look out for? The role of carbon markets in Net Zero and the size of…

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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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The New Era of Food Safety Needs a Great Team with Strong Leadership
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

The New Era of Food Safety Needs a Great Team with Strong Leadership

September 30, 2022

Demonstrating that even before the global pandemic, people have always been the catalysts of change and the difference-makers in every aspect of our business, and especially when it comes to Food Safety, Quality, and Compliance How do you identify, support, and develop the future leaders of your organization to carry on the FSQ values your company is built upon? Mobilizing the unique culture of our team to embracing transformation and fresh perspectives while holding onto the best of what has always driven positive outcomes in turbulent times Creating a framework that encourages all employees to unlock their potential personally and…

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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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New Technology Helps Improve Food Safety, Reduce Risk and Transforms Pest Management
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

New Technology Helps Improve Food Safety, Reduce Risk and Transforms Pest Management

November 29, 2020

IoT Connected devices monitor 24/7 inside and outside of facilities Enables immediate response and root cause analysis Enables more thorough pest inspection Provides service transparency and accountability Proactive vs. Reactive pest management Improves audit readiness and compliance — Peter Jardine Head of Marketing and Strategy Bayer Digital Pest Management In his career, Peter has focused on differentiating brands, creating new products and services. He has launched over 20 new products and services in numerous market segments including B2C and B2B. Peter gained pest management experience when he joined Orkin Pest Control as the Sr. Director of Strategy and Innovation and…

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From the Consumer’s Perspective
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

From the Consumer’s Perspective

October 29, 2020

What do consumers understand about food safety? What is important to your consumer? Exploring effective communication strategies to convey food safety messaging to your consumer — Jim Rogers Director of Food Safety Research and Testing Consumer Reports James. E. Rogers, Ph.D. is the Director of Food Safety Research and Testing at Consumer Reports. He is responsible for leading the food safety and sustainability operations of the organization, including food testing, data analysis, and risk and safety assessments for various foods. Prior to joining Consumer Reports, Dr. Rogers held various positions at the USDA Food Safety Inspection Service. This includes serving…

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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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Improving Product Quality During Technical Transfers
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Improving Product Quality During Technical Transfers

November 25, 2019

The definition of Technology Transfer and its many applications Planning for tech transfer the “right way,” using “Calculated Risk Reduction” and other tools to ensure all bases are covered Common pitfalls and best practices – what to do, and what not to do Ways to ensure optimal planning and execution using actionable tools — Eric Good Director, Compliance ProPharma Group Dr. Eric Good is an energetic leader with extensive U.S. and international manufacturing, project management, Consent Decree and quality systems experience with Fortune 500 Companies. Dr. Good has 29 years of award winning high-performance. He is an active leader in…

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Communication and Collaboration in the Food Industry – A Conversation with Gary Nowacki
FOOD SAFETY & QUALITY, VIDEO

Communication and Collaboration in the Food Industry – A Conversation with Gary Nowacki

July 31, 2019

At North American Food Safety & Quality 2019 last month in Chicago we spoke with Gary Nowacki of TraceGains about how data management and the sharing of information throughout a supply chain are ever-present challenges for Food and Beverage companies. TraceGains works to connect business partners seamlessly and easily to facilitate communication and collaboration. To hear more on this topic, here is a link to Gary’s workshop from NAFS19 that we shared earlier. — TraceGains is a rapidly growing software company, delivering a sophisticated suite of products for food, beverage, and CPG companies. TraceGains solutions empower our customers to satisfy…

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