Tag: 3BL

Increased availability of testing and antiretrovirals has led to global progress in preventing and managing infectious diseases like HIV, tuberculosis (TB), malaria and hepatitis in the last quarter of a century. However, progress is slower in some low- and middle-income countries (LMICs) where the needs are greatest, especially among more vulnerable groups like women and children. In addition, the COVID-19 pandemic, continuing emergence of antimicrobial resistance (AMR) and growing impacts from climate change have demonstrated how infectious threats can emerge and have devastating global effects.

At Viatris, we have expanded access at scale to high-quality HIV/AIDS treatment for more than a decade. Our work includes helping to prevent HIV infections, increasing diagnosis and treatment and providing healthcare solutions. We also are working on local manufacturing initiatives with partners to transfer technology to expand access where it is most needed. Over the years, we have continued to seek improvements to existing molecules to better meet patient needs, including introducing novel heat-stable generic formulations, more convenient packaging options and pediatric therapies as well as extended shelf life for certain products.

Number of countries to which we provide access to high-quality and affordable ARVs ~125

Percentage of people on treatment for HIV that use a Viatris product1 ~32%

Viatris has worked to provide in-vitro HIV rapid diagnostic tests for self-testing in LMICs, and during 2023, we continued work to develop a dual oral pill for HIV and birth control in collaboration with the Bill and Melinda Gates Foundation and the Children’s Investment Fund Foundation. The product is expected to be filed with the WHO PQ approval by the end of 2024. All the above are important components to make progress on the collective goals of preventing HIV infections, expanding treatment and providing healthcare solutions to people living with HIV.

During 2023, we continued our partnership with the international, not-for-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) for the development of flucytosine slow-release formulation, a drug used for the treatment of cryptococcal meningitis, with the intention to reduce the pill burden and increase treatment adherence.

As part of our strategy to expand access to ARV treatments, we are working with international organizations for pooled procurement, engaging in licensing agreements with originator pharmaceutical companies and the Medicines Patent Pool and participating in government tenders. We provide a single price for all applicable countries supplied via leading global procurement mechanisms, The Global Fund to Fight AIDS, TB and Malaria, and the U.S. PEPFAR Program.

Viatris has eight licensing agreements with the Medicines Patent Pool (MPP) for HIV – including PrEP – hepatitis C and COVID-19. For ARV and infectious disease products, Viatris also has license agreements with Gilead, Viiv Healthcare, MSD, TB Alliance and Otsuka.

Product registrations are an important part of enabling access to patients across geographies. We consistently file our ARV treatments with the U.S. FDA and the WHO Prequalification pathways to enable procurement by PEPFAR, the Global Fund to Fight AIDS, TB and Malaria, as well as other international agencies. Still, many countries require local registration in addition to these global approvals. To meet this need, we have steadily been filing for local market authorizations of our ARV products based on country guidelines across all key high-burden HIV countries.2 

Viatris files all relevant ARV products based on country guidelines across key high-burden HIV countries. We have more than 700 registrations of infectious disease products across LMICs.

In 2023, Viatris engaged with WHO to seek scientific advice for regulatory approval of two different medicines improving on existing molecules to better meet needs of people living with and at risk for HIV, building on our long legacy of making relevant improvements in these medicines. In 2023, the shift to consolidate treatments for patients using ARVs continued, meaning that most of the HIV programs across LMICs transitioned to a dolutegravir-based regimen across first-line, second-line and pediatric populations.

Despite significant progress made over the years, the burden of HIV remains high in many countries. Estimates indicate that around 2.47 million people in India are living with HIV.3 Viatris has been a trusted partner to the government over several years in supplying HIV medicines and in 2023, Viatris launched in India a single pill combination HIV treatment of tenofovir alafenamide, emtricitabine and dolutegravir, reaching more than 4,000 patients in the first six months it was available.

In the last two years, Viatris has launched more than 10 new ARVs in South Africa, including a darunavir/ritonavir combination used for difficult-to-treat HIV patients when initial treatments have failed or not been tolerated, as well as the first fixed-dose tenofovir alafenamide combination to be available in South Africa. This has provided patients living with HIV increased access to leading treatments, helping to improve HIV outcomes in the country and contributing to the fight against HIV.

Improving Treatment for Children Living with HIV

Protecting and improving the health of children is a fundamental global health priority. Although significant strides have been made, there are still major disparities globally, with children in LMICs being among the most vulnerable. Complexities around formulations and dosage guidelines can often be hurdles to children accessing the care they need.

We have built strong partnerships with multiple stakeholders to improve access to ARVs, with particular attention to vulnerable populations like children. For example, in partnership with Viiv Healthcare and the Clinton Health Access Initiative (CHAI), Viatris has worked to develop a dispersible form of treatment which will reduce the pill burden in pediatric populations, which hopefully will significantly improve the treatment experience for children living with HIV.

Viatris has more than 150 medicines in the 2023 Essential Medicines List for Children. This represents more than 40% of the total list.

Viatris has more than 45% of the anti-infective medicines in the Essential Medicines List for Children.

Approximately 65% of children on treatment for HIV use a Viatris product.4

In 2023, we received approval of a single tablet regimen – the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg – that will reduce the pill burden for children living with HIV.

In South Africa, we provided access to leading fixed-dose combinations for children living with HIV by launching Dumiva dispersible and dolutegravir dispersible in 2023, which enable caregivers to provide easy-to-administer medication to children as opposed to syrups that can be difficult for some children to take.

These milestones support the company’s sustainability goal to provide ARV therapy equivalent to a total of 30 million patients, including more than 2 million children living with HIV/AIDS, between 2022 and the end of 2025.

The Power of Partnerships in Treating TB

Our work in infectious disease also includes a focus on TB, one of the leading causes of infectious disease deaths worldwide.5 In many cases, TB can be cured with an antibiotic treatment regimen for six months; however, non-adherence is a challenge for TB control and prevention programs. Non-adherence to TB treatment increases the risk of morbidity and mortality and fuels drug resistance, impacting both individuals and communities.

Through our continued partnerships, Viatris has launched pretomanid, specifically approved for adults with multidrug-resistant TB (MDR-TB). It’s only the third new anti-TB drug approved in the past half-century. It was developed by TB Alliance, a nonprofit organization that develops and delivers new TB treatments.

In 2023, we completed another 57 registrations for pretomanid, and we are awaiting approval in 10 countries, spanning across multiple continents and income levels.

Partnerships like the one with TB Alliance are essential to providing more sustainable access to medicine. Pretomanid reached patients in more than 40 countries in 2023.

Continuing Our Commitment to Prevent and Treat Hepatitis

Hepatitis is an inflammation of the liver that is caused by a variety of infectious viruses and noninfectious agents leading to a range of health problems, some of which can be fatal. For examples, types B and C lead to chronic disease in hundreds of millions of people and together are the most common cause of liver cirrhosis, liver cancer and viral hepatitis-related deaths. It’s estimated that more than 350 million people worldwide live with hepatitis B or C, and for many, testing and treatment are out of reach.6 We have a long tradition of helping to address hepatitis B and C, both through awareness and prevention and in making treatment more available.

Fighting TB in India

India leads the world in TB cases, a stark statistic that caused the government to set an aggressive target to eliminate TB in India by 2025.3 As many as 45,000 people are being treated for MDR TB in India. More than 10,000 of those patients were treated with a Viatris product, delamanid, in 2023. Viatris supplied this medicine through participation in a government tender and through India’s first order through the Global Drug Facility of the Stop TB Partnership, an innovative public-private partnership.

Examples from our work in 2023 include:

In the Philippines, a partnership with PHILUSA we offered a lower priced product to patients living with hepatitis B.In Myanmar, in collaboration with Burnet Institute, nearly 800 hepatitis C patients were treated with MyHepDVIR at a subsidized price. This marked one of the largest treatment initiatives ever conducted for hepatitis C in Myanmar, a country that carries a disease burden of 1.3 million people living with hepatitis C.Collaborated in Bulgaria with the patient organization HepActive to raise awareness of hepatitis B risk factors, diagnosis and treatment adherence and to provide psychological support to patients diagnosed with hepatitis B through webinars and social media campaign.

View the full 2023 Sustainability Report.

Sources

1 Excludes the U.S., EU and other developed markets. Also excludes Russia, China and Mexico, where we do not commercialize ARVs 
2 WHO Global List of High Burden Countries 
3 India HIV Estimates Report 
4 Excludes the U.S., EU and other developed markets. Also excludes Russia, China and Mexico, where we do not commercialize ARVs. 
5 WHO Tuberculosis Fact Sheet 
6 WHO Hepatitis Fact Sheet

Originally published by NYU Tandon School of Engineering on PRWeb

As we prepare to return to classrooms this fall, NYU Tandon’s NYC Media Lab, in partnership with Verizon, delivers on our joint commitment to empower educators and engage students by releasing brand-new immersive learning resources on Verizon Innovative Learning HQ—the free education portal that makes innovative learning tools available to all.

The immersive learning resources were developed by education experts from NYC Media Lab’s $1M Museum Initiative, a program aimed at connecting educators nationwide with museums, science centers, aquariums, and cultural institutions.

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Whether you’re a startup, a business that may have a change in operations, or you’re in a new role or have joined a new organization, you may want to keep reading. Do you know which environment, health, and safety (EHS) requirements apply to your industry and operations? Do you have a plan to meet them and avoid the risks of non-compliance?

If you answered no to any of these questions, you might benefit from an EHS applicability assessment. In our recent webinar, “Changes to Your Business? How to Know What Your Environmental, Health, and Safety Obligations Are,” Lauren Corbett-Noon, EHS Compliance & Auditing Leader, moderates an informative session about EHS applicability assessments. Mike Pauli, a lead EHS Auditor at Antea Group, and Becky Matich, EHS Audits and Assessments services lead, share strategies for how to understand which EHS regulations apply to your business, and how to evaluate the potential EHS implications of a change in your business operations. Business changes may include a process change, an expansion, an acquisition, or maybe you’ve heard about a change in a regulation and you’re not sure if it applies to your business.

Missed the webinar? Watch on-demand below.

Watch On-Demand

What is an EHS Applicability Assessment?

First, an EHS applicability assessment is a process of identifying and understanding the relevant EHS requirements applicable to your business. It involves collecting information about your operations, processes, materials, and equipment, and then determining which EHS regulations apply at the federal, state, and local levels.

The outcome of an EHS applicability assessment is a customized report that summarizes your EHS obligations and provides recommendations for compliance. The report also prioritizes the most critical or urgent actions that you need to take, such as applying for permits, developing programs, or conducting training.

Why is an EHS Applicability Assessment Important?

Compliance with EHS regulations is not only a legal obligation, but also a strategic advantage for your business. Below are some of the benefits of conducting an EHS applicability assessment. It can:

Reduce the risk of non-compliance, fines, accidents, and injuries that can harm your employees, customers, environment, and reputation.Improve your environmental performance and social responsibility, which can enhance your brand image and customer loyalty.Foster a culture of integrity and transparency, which can boost your employee engagement and morale.Help you plan and prepare for changes in your operations that might trigger new or different EHS requirements.Help you plan and prepare for potential regulatory changes that may impact your operations.Provide you with a clear and comprehensive understanding of your EHS responsibilities and how to meet them.

When Should You Consider an EHS Applicability Assessment?

You should consider an EHS applicability assessment in the following situations:

You are a new EHS manager, or a contractor, and you need to understand the EHS requirements that apply to the facility or operation that you are responsible for.You are expanding or modifying an existing facility, and you need to know what EHS permits, licenses, plans, and programs you need to have in place before you begin operation.You are making changes to your products, processes, or equipment, and you need to evaluate the impact of these changes on your EHS obligations and update your EHS controls accordingly.There are new EHS regulations that affect your industry, and you need to evaluate the impact of these changes on your EHS obligations and update your EHS controls accordingly.You are opening a new facility in a different location, and you need to know what EHS regulations  apply to the new location and how they differ from the ones that apply to your existing facilities.

How is This Conducted?

Conducting an EHS applicability assessment can be a complex and time-consuming task, especially if you are not familiar with the EHS regulations that apply to your business. That is why you might want to consider hiring a professional EHS consultant to help you with this process.

An EHS consultant can provide you with the expertise, experience, and tools to conduct a thorough and accurate EHS applicability assessment. They can also tailor the assessment to your specific needs and context, such as focusing on environmental or health and safety aspects or covering multiple facilities or locations.

The typical steps of an EHS applicability assessment process are:

Completing a questionnaire to gather basic information about your business and operations.Conducting a site visit to observe your operations, processes, materials, and equipment a, and to interview key personnel.Determining the applicable EHS regulations based on the information collected.Preparing a report that summarizes your EHS obligations and recommendations for compliance and prioritizes the next steps.

Wrap-Up

An EHS applicability assessment is the first step in building a solid foundation for EHS compliance. It can help you identify the gaps and opportunities in your current EHS practices and provide you with a roadmap for improvement. It can also help you avoid the costly and damaging consequences of non-compliance and enhance your business performance and reputation.

EHS compliance is not a one-time event, but a continuous process that requires ongoing care, review, refinement, and improvement. You may need to use different methods and tools, such as recurring inspections, internal or external audits, legal registers, management systems, or software programs, to maintain and monitor your EHS performance. However, it all starts with knowing which EHS regulations apply to your business, which is what an EHS applicability assessment can help you achieve.

If you are interested in conducting an EHS applicability assessment for your business, reach out today, our team is ready to help.

Originally published in American Airlines’ 2023 Sustainability Report

Marc Shapiro is the Director of the Breakthrough Energy Contrails team, one of American’s partners on contrail avoidance. Below, he answers our questions on the science behind contrail avoidance strategies, as well as some of the challenges in their implementation.

Prior to joining Breakthrough Energy, Marc worked as an applied scientist and entrepreneur in a diverse set of research and development efforts across fluid mechanics, geospatial analytics and mobile healthcare. In 2020, he started a company to develop geospatial data systems for climate mitigation and adaptation before transitioning to his current work. Marc earned a Master of Science degree in Fluids and Thermal Sciences from Brown University and a Bachelor of Engineering from Dartmouth College.

Marc, how would you compare the warming impact of contrails versus CO2 ?

It’s hard to compare them precisely, but CO2 is weakly warming over a long period of time, while contrails are strongly warming over a short period. But not all contrails have the same warming effect. Persistent contrails at night clearly impact the climate the most. By being more precise in our interventions and focusing on those, we have the greatest opportunity to make a difference.

How can we predict where warming contrails will occur?

There are fundamentally two ways to go about this. One involves using physics and meteorology to predict regions or volumes of air that should be avoided. The other uses observational techniques on the ground and from satellites to see where aircraft are actually forming contrails. In our work towards solving this problem, we need both.

What are the scientific challenges?

The type of atmospheric condition that creates persistent contrails is called ice supersaturation, which is a fancy way of saying the temperature is really cold and the humidity is high. Predicting that state is something that models have a hard time doing today. Another challenge is predicting these atmospheric states on as fine a scale as you need. Weather forecasts generally correspond to a grid, say, 25 kilometers by 25 kilometers. In that grid, you might have multiple fluctuations of supersaturation states. So, the model resolves to the average and it’s wrong sometimes.

Is there an easy way to describe your model?

Think of it like a weather forecast. We predict the probability that a contrail will form and an estimate of that contrail’s severity. The first part indicates how likely it is that an aircraft will form a persistent contrail in a particular area. The second part tells us that if we found a contrail in that area, it would likely have a particular persistence and impact on the climate.

Avoiding a contrail might also result in greater CO2 emissions. How should we look at the trade-off?

There is a cost in added fuel and CO2 that potentially gets added to the atmosphere as a result of avoidance maneuvers. Our models are telling us, though, only a few flights will be affected, and avoidance still results in a net climate benefit even over 100 years. We could reduce these added emissions if airlines had access to SAF. But from an operating standpoint, there’s a cost to the airline business in terms of greater fuel use, and no mechanism exists to share that cost right now.

How do you see American’s role in helping advance the solution?

The airlines are essentially on the front line of solving this problem because you are the ones that would implement the solution. So, what American is doing in helping us run trials is truly critical to advancing the research. The biggest hurdle to get through right now is not model development. It’s having the chance to really test and validate the model. Additionally, having a major airline working on this issue is a valuable signal that it’s important.

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By using creativity and persistence, the packaging department team at Yamagata, Japan, managed to reduce their waste plastic material by 11 percent, making them an inspiration for all sites globally. And it all started with one small idea.

Boehringer Ingelheim’s Yamagata site – 400 kilometers north of Tokyo – is surrounded by beautiful nature. On her daily drive to work, Yuko Goto, who works in the Yamagata packaging department, sees both the snow-covered Mount Gassan on the horizon and the many cherry fields that the Yamagata prefecture is famous for. “I feel very close to nature here,” says Yuko, “I am happy to live and work in such a beautiful environment.”

In the packaging department, Yuko and her colleagues guarantee a steady supply of 45 different Boehringer Ingelheim products for customers and patients in Japan. Yamagata started bulk exports to regional markets like Australia and New Zealand in 2023, and Yuko’s team is also responsible for packing for export. Packaging medicines in an automatic process creates scrap waste when the margin of the plastic film is cut away. The Yamagata site currently produces 2 billion tablets a year – a process that leads to 16 tons of plastic waste material.

“I have two children, and it is important to me to pass on a better future to the
next generation” – Yuko Goto, worker at the Yamagata Packaging Department

Working close to the production line, the amount of scrap waste produced became evident to Yuko – and something she decided to change. In 2021, she submitted a proposal to re-evaluate the established production process to reduce material loss and to improve packaging efficiency. “It was just sad to see all the material scrap waste, so we had to act,” Yuko explains. At Yamagata, employees are encouraged to submit their own ideas for small “quick-win” projects. This approach, called “Kaizen”, has led to a continuous flow of proposals for improvement. “I have two children, and it is important to me to pass on a better future to the next generation,” Yuko shares.

Using our resources in a sustainable way

The approach in Japan is true for all of us at Boehringer and a great example of what we aim for. Our Leitbild states that “we feel responsible for our communities and are respectful of our resources”. Boehringer will always strive to be better: develop better therapies, enable better healthcare solutions, and contribute to a better world for future generations. This includes protecting natural resources and reducing waste. The world’s natural resources are not endless. To use them sustainably, the amount extracted needs to reflect the resources’ capacity to recuperate and regrow.

“Our societies are currently using more resources than we have,” says Anthony Matheri, Senior Manager Circular Economy at Boehringer. “According to the Global Footprint Network, by May countries like Germany or Japan have used more resources than one earth can sustainably support.“ Boehringer is aiming to do its part to reduce the global over-usage of resources. Through the global MORE GREEN program and by applying a holistic approach, we are working to reduce our environmental footprint, including in areas such as carbon emissions, energy, water, and waste.

“By bringing together our global community, we can help and inspire each other.”

– Dr. Anthony Matheri, Senior Manager Circular Economy at Boehringer Ingelheim

Circular Economy helps us to keep resources in a loop

The concept of circularity – one component of which is waste reduction – promotes moving away from a linear business model of take-make-dispose. Instead, the approach encourages a circular business model that “closes the loop”. This means keeping resources in a “circular loop” where material is recycled and reused for as long as possible, or where the use of raw material is reduced altogether. “One way that we are increasing circularity within our operations is through eco-design and green chemistry,” Anthony explains, adding “This means challenging the status quo and considering product sustainability throughout the product life cycle of the end-to-end value chain.”

That was a key learning for the Japanese team. The machine manufacturer claimed that it was impossible to change established processes. But the team did not want to give up. So instead, they started innovating on their own and found a way to reduce material loss and to improve the packaging efficiency of three blister machines. They successfully reduced the scraps for the plastic film connection by half. This resulted in a waste reduction of 100 meters of film per process order.

By re-evaluating their processes, the Yamagata team managed to shorten the width of plastic film by 2 mm, leading to another reduction of 1.8 tons of waste. This also meant the scrap waste was reduced by 11 percent.

The team managed to reduce 11 % of scrap waste through the re-evaluation of processes

“There were many challenges, but in the end, we found a way to reduce the width of the plastic film and optimize the packaging material,” Yuko says with a smile on her face. In addition to the waste reduction, the weight reduction of the packaging materials has led to unexpected benefits. For example, logistics have become more efficient and employee safety has increased, since less volume means less weight that workers need to handle when transferring goods.

Reducing plastic waste further

This project, which started as one small idea, has now snowballed to create new projects which reduce plastic waste even further. The Yamagata site is also currently consulting with the machine manufacturer to see how they can collaborate to reduce packaging scrap waste even further – or altogether. In addition, since the blister machine manufacturer has the highest market share in Japan, our initiative opens up the possibility for many other clients to implement changes as well, thus benefiting not just Boehringer, but society as a whole.

So how can a project that reduces plastic film by 2 millimeters in Japan help us decrease our environmental impact globally? “No one can be an expert in all areas,” Anthony points out, “but by bringing together our global community, we can help and inspire each other.” Key to this is building systems of knowledge exchange between different cross-functional teams around the world. In this way, we are sharing the experiences gained from local circularity projects and using them to initiate and scale up similar projects at other sites.

Anthony summarizes: “The waste reduction project in Japan has the potential to not only increase the circularity of Boehringer’s operations locally, but also inspire many more similar waste reduction projects at Boehringer sites around the globe.”

Every kilo helps, and everyone can contribute when it comes to waste reduction. “Small things can make a huge difference”, Yuko agrees and tells us about how the project has given her the confidence that she can do more for the future. “I questioned what I took for granted and realized the importance of breaking down stereotypes and continuing to challenge myself. To contribute to a big change, I learned to find small opportunities and take action.”

Plastic pollution – tiny particles with a long-lasting impact

Plastic pollution poses a critical challenge within circularity. Plastic is not biodegradable, i.e. instead of decomposing, the material breaks down into smaller and smaller pieces. These so called micro- or nano-plastics have a devastating effect on the world’s health. They enter waterways and oceans, negatively impacting the health of both humans and animals. Boehringer is working on sustainable optimization solutions for these issues in line with the work of the United Nations Environment Programme (UNEP). Their joint goal: A healthier future for humans, animals and the environment.

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Find out more about Boehringer Ingelheim’s global sustainability initiatives, ranging from creating more sustainable healthcare solutions and community engagement with impact to environmental stewardship in Imagine: our sustainability story hub.

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In the ever-evolving landscape of food safety, the journey from Good Manufacturing Practice (GMP) to Global Food Safety Initiative (GFSI) systems and audits represents a pivotal shift towards heightened standards and rigorous expectations of customers and retailers. This transition underscores a commitment to excellence and reflects the dynamic interplay between regulatory compliance and consumer trust. The many complexities of this transformation also bring myriad benefits for companies and consumers — from bolstering food safety protocols to enhancing market competitiveness.

In this blog, we explore some of these benefits along with the challenges of transitioning from GMP to GFSI, as well as how SCS Global Services can help you achieve your food safety goals. We will also answer some of the most frequently asked questions about GFSI, such as:

What is GFSI and what does it do?What are the differences between GMP and GFSI audits?What are the advantages of GFSI certification?What are the challenges of GFSI implementation?How do I choose the right GFSI recognized audit for my business?How can I prepare my company for a successful GFSI audit?How can SCS help you with GFSI auditing, training, and consulting?

Who is GFSI and what does it do?

GFSI is a non-profit founded in 2000 by the Consumer Goods Forum, a global network of retailers and manufacturers. GFSI’s mission is to provide continuous improvement in food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide.

GFSI does not conduct audits or certify food facilities. Instead, GFSI sets the benchmark for food safety standards and recognizes the schemes that meet its criteria. GFSI also facilitates the collaboration and harmonization of food safety practices across the industry and provides guidance and resources for food businesses to improve their food safety performance.

Some of the most popular GFSI-recognized schemes are:

BRCGS (Brand Reputation Compliance Global Standard)SQF (Safe Quality Food)FSSC 22000 (Food Safety System Certification)GLOBALG.A.P. (Good Agricultural Practices)PrimusGFS (Global Food Safety)

Each scheme has its own scope, requirements, and certification process, but they all follow the GFSI benchmarking framework, which ensures a consistent and high level of food safety across the global food supply chain.

What are the differences between GMP and GFSI audits? 

GMP audits serve as the basic level of food safety audits, and they focus on the hygiene and operational conditions of a food facility. GMP audits are based on the regulatory requirements of the Food and Drug Administration (FDA) or the United States Department of Agriculture (USDA), depending on the type of food product. GMP audits are also conducted by state and local authorities and by third-party certification bodies, such as SCS.

GFSI audits are the advanced level of food safety audits, and they cover the entire food safety management system of a food business. GFSI audits are based on a rigorous benchmarking framework, which incorporates the Codex Alimentarius principles and the specific requirements of each scheme. GFSI audits are only conducted by accredited certification bodies, such as SCS Global Services, that are approved by the scheme owners, and that have qualified, trained auditors who understand the complexity of the products they are assessing.

Some of the main differences between GMP and GFSI audits are:

GMP audits are a great entry point to establishing food safety programs, but GFSI is more robust and already approved by customers and retailers.GMP audits are checklist-based, while GFSI audits are performance-based.GMP audits are usually announced, while GFSI audits have a mandatory, unannounced cycle.GMP audits are usually shorter than GFSI audits because GMP audits are not benchmarked to meet minimum duration requirements.GMP audits do not require food safety culture commitment, which is becoming a regulatory requirement.

What are the advantages of GFSI certification?

GFSI certification has many benefits for food businesses, such as:

Enhancing food safety and quality and reducing food safety risks and incidentsImproving customer confidence and satisfaction and increasing market access and competitivenessReducing audit duplication and complexity and saving time and moneyAligning with the best practices and standards in the industry and demonstrating leadership and commitmentSupporting continuous improvement and innovation and fostering a food safety culture

What are the challenges of GFSI implementation? 

With the increased rigor and higher standards associated with GFSI, implementation can pose some challenges for food businesses, such as:

Requiring more resources and expertise, often involving more internal stakeholders and greater responsibilityRequiring more policies and procedures, which bring more record-keeping and traceabilityRequiring more training and education plus more internal and external auditsRequiring more investment and maintenance along with more corrective and preventive actionsRequiring more time spent planning along with more change and adaptation

Although these challenges may be experienced upon initial preparation, a committed team that is knowledgeable and supportive can ease these constraints while increasing your business profitability, brand protection, and growth.

How do I choose the right GFSI scheme for my business? 

There is no one-size-fits-all answer to this question, as each GFSI scheme has its own advantages and disadvantages, and each food business has its own needs and preferences. That being said, some of the following factors can help your organization make an informed decision:

Your product category and scope plus the suitability of the scheme for your type of foodYour customer requirements and expectations and the acceptance of the scheme by your target marketsYour familiarity and experience with the scheme and the availability of the scheme resources and guidanceYour technical resources and capabilities along with the availability of the scheme auditors and certification bodiesYour cost, budget, and the return on investment of the scheme

How can I prepare my company for a GFSI audit?

Preparing for a GFSI audit can seem like a daunting task, but with commitment and diligence, it can also be a rewarding opportunity to improve your food safety performance and achieve your certification goals. Some of the steps that can help you prepare for a GFSI audit are:

Register with the scheme owner and select the certification body, such as SCS Global Services, that will conduct your audit.Download the scheme standard and checklist and conduct a gap assessment to identify your strengths and weaknesses.Develop and implement your food safety management system and document your policies and procedures.Train and educate your staff with key, required training such as Hazard Analysis and Critical Control Points (HACCP) and scheme standard requirements.Communicate the steps needed to ensure compliance with your management team.Conduct internal audits and mock exercises to verify and validate your food safety plan.Address any non-conformities and corrective actions in a timely manner.Review, challenge, and update your records and traceability.Confirm your audit date and scope with the Certification Body and Auditor.Prepare your facility and staff for the audit day by increasing training, interviews, and team meetings.

How can SCS help you with GFSI certification?

SCS is an international leader in third-party food safety certification, and we have over 40 years of experience and expertise in the food and agriculture industry. We offer a full range of services to help you achieve your GFSI certification. In the sections below, we walk through several of the specific services that may benefit your company.

Training and Consulting

We offer public, private, and on-demand interactive training on various topics, such as HACCP, preventive controls, food defense, food fraud, food safety culture, and specific GFSI schemes. We provide trainings in both English and Spanish to ensure competency throughout your facility.

Consulting

We also offer consulting services to help you develop, implement, and improve your food safety management system. We do this through documentation preparation, onsite gap assessments, and verification activities that ensure the audit readiness of the site and team.

Auditing and certification

We offer auditing and certification services for various GFSI-recognized schemes, such as BRCGS, SQF, GLOBALG.A.P., and PrimusGFS. We have a team of qualified and experienced auditors who can conduct your audit in a professional and objective manner. We also have a team of technical and customer service staff who can support you throughout the certification process.

Other services: We offer other services that can complement your GFSI certification, such as product claim verifications, including gluten-free, USDA Organic, Non-GMO Project Verified, as well as sustainability; standards development and strategic consulting, such as life cycle and gap assessments.

SCS Global Services looks forward to helping your organization move from GMP to GFSI. If you are interested in learning more, consider watching the replay of our webinar, “Unraveling GFSI certification – Pathway to move beyond GMP & Non-Accredited Audits.” And if you have any questions or comments, please feel free to contact Denise Webster, Vice President of Food Safety: dwebster@scsglobalservices.com.

There has been a lot of discussion and inquiries surrounding CSRD and how will it impact business and operations. Let us walk through some of the basics and outline immediate implications and possible anticipations for companies with business in the EU.

The main takeaway is that the context and conditions of doing business in Europe are in transition towards a sustainable economy. This policy & regulation driven transition is all centered around integrating ESG (environmental, social and governance) criteria into business operations. Commonly predicted effects of this integration are:

Stakeholders will have access to more detailed and comparable ESG information.Verification of non-financial ESG information will be like for financial reporting.The conditions for acquiring investments and loans will be more attractive for sustainable activities.

History of the EU Green Deal

The first commitments made by the international community to reduce GHG emissions were in the Kyoto Protocol in force since 2005. In Europe, the EU Green Deal was adopted in early 2020 with the goal of being the first climate-neutral continent transforming the EU into a modern, resource-efficient and competitive economy, ensuring:

net zero emissions of greenhouse gases by 2050economic growth decoupled from resource useno person and no place left behind

This became the framework for a range of directives and regulations to deliver the EU Green Deal ultimate goal: a sustainable economy.

The Green Deal is complex. Its elements are launched over a period of several years. The elements are based on best available knowledge, and therefor subject to change. Constant additions, negotiations and changes will be part of the deal. It will be essential to understand the basic implications, requirements and timelines set forth. For both EU companies and companies outside the EU with EU business dependencies.

Corporate Sustainability Reporting Directive (CSRD) – An Introduction

The Corporate Sustainability Reporting Directive (CSRD) is bringing together, in a more cohesive and comparable framework, much of the data and technical EHS reporting that your company should already be tracking. It is an update of the Non-Financial Disclosure Regulation- NFDR, aligning it with other regulations and standards, like the Global Reporting Initiative (GRI).

It will not be a one-size-fits-all. Understanding through ‘double’ materiality assessment of what matters most to your business is the key. ‘Double’ means to be about the material impact of your business activities on the environment and society, and how sustainability issues are impacting your business. Within the CSRD framework, the European Sustainability Reporting Standards (ESRS) provide a standardized format for reporting about material topics and sub-topics.

CSRD – Timelines and Structure

Based on the status of deployment of the Green deal in January 2024, multinationals will begin reporting in 2025 based on FY2024; large enterprises in 2026 based on FY2025; and publicly listed SMEs in 2027 based on FY2026 (with an opt out option to 2028). As the definitions and criteria for these groups are subject to changes, please refer to official EU sources for the actual details.

ESRS and new concepts for sustainability reporting 

The European Sustainability Reporting Standards (ESRS) contains the criteria for reporting, based on the double materiality assessment for each company to decide which elements to include in their own reporting. There will be mandatory third-party verification audits. Data would eventually be XBRL tagged (digital tag) for easier comparable searches online.

The ESRSs require understanding of material risks and opportunities in the full value chain. For example, in the case of an apparel company, with the circumstances surrounding the sourcing of materials for clothing in Vietnam from another company in your supply chain are of material concern. Expanding materiality across the value chain brings about a larger data requirement for companies, requiring engagement upstream, even when those businesses outside of the EU.

New to CSRD is the inclusion of “nature” as a silent stakeholder to be considered in assessments and reporting. Companies should consider the implications of how operations are impacting nature or creating a more sustainable path.

Moving Forward

Companies will need to start evaluating their current data and gaps to CSRD and understand reporting timelines and requirements needed. This policy & regulation driven transition is all centered around integrating ESG (environmental, social and governance) criteria into business operations in order to disclose non-financial information about material sustainability impacts of a company’s business. CSRD is part of a coherent set of elements of the EU Green Deal. All of these elements are designed to work in harmony to create transition to a climate neutral and sustainable economy in the EU and beyond.

Our global network of Associates can support your sustainability reporting including CSRD.

Inogen Alliance is a global network made up of dozens of independent local businesses and over 6,000 consultants around the world who can help make your project a success. Our Associates collaborate closely to serve multinational corporations, government agencies, and nonprofit organizations, and we share knowledge and industry experience to provide the highest quality service to our clients. If you want to learn more about how you can work with Inogen Alliance, you can explore our Associates or Contact Us. Watch for more News & Blog updates here and follow us on LinkedIn

Originally published on GoDaddy Resource Library

Tell us a little bit about the both of you and what you currently do at GoDaddy?

Renee Deines serves as the Manager of Care Incentives, affectionately known as ‘Dr. Fun,’ within the Incentives and Recognition Team at GoDaddy. With over eleven years of experience at the company, she plays a pivotal role in developing contests, recognition programs, events, and fostering a vibrant company culture.

Lanie Moser, on the other hand, is the Director of Employee Relations. As part of a dedicated team, she specializes in employee engagement, performance management, and navigating employee relations, including policy interpretation and addressing policy violations. Lanie has been with GoDaddy for twelve years, now!

Outside of work, you have a party equipment rental business. Would you mind sharing more about it and how it came to be?

Throughout their time at GoDaddy, Lanie and Renee have cultivated a strong friendship, bonded by shared experiences such as navigating IVF journeys and welcoming children within a close timeframe. Their conversations often revolved around their entrepreneurial aspirations and the dream of launching their own businesses. This dream took shape when they decided to partner in creating Queen Creek Soft Play. They are firm believers in the power of manifestation. Just a month after their decision, they officially launched their business and were thrilled to receive booking requests almost immediately.

Outside of work, Lanie and Renee embarked on an exciting venture in the events and entertainment industry. Initially unsure of which specific direction to take, they were confident in their ability to succeed no matter the path. During their exploration, Lanie stumbled upon a remarkable opportunity: the previous business she had used for her daughter’s birthday was up for sale, complete with all its equipment!

Recognizing the potential, Lanie and Renee arranged to meet with the business owners, negotiated a deal, and successfully purchased the entire operation. Over the course of just one month, they transformed their vision into reality. They diligently moved all the equipment, developed a professional website, established an email account, opened a business bank account, and meticulously cleaned each piece of equipment.

To enhance their brand, they partnered with a talented marketing company for logo design and website content, and hired a professional photographer to capture stunning product images. Throughout this whirlwind of activity, they managed to balance their responsibilities at GoDaddy while also being present for their families, showcasing their dedication and entrepreneurial spirit.

What advice would you give to others who are looking to start a side hustle while working full-time?

If you’re considering starting a side hustle while juggling a full-time job, Lanie and Renee have some valuable advice to share. First and foremost, leverage your network. Tap into the strengths and insights of those around you, and don’t hesitate to accept help when it’s offered. Just as it takes a village to raise a child, it also takes a village to build and grow a successful business!

Make the most of the resources available at GoDaddy. Beyond the exceptional products, there’s a wealth of knowledge and expertise within the community. From building and troubleshooting to engaging with our Employee Resource Group, GoDaddy Entrepreneurs in Tech, that offers learning opportunities and coaching, the support network at GoDaddy is vast and has played a crucial role in Lanie and Renee’s success. Remember, everyone at GoDaddy embodies an entrepreneurial spirit and will be cheering you on!

Lastly, embrace the power of positive self-talk. Lanie and Renee live by the mantra, “What you talk about, you bring about.” Share your visions of success, articulate your goals, and discuss your aspirations for the future—whether that’s one year, five years, or ten years down the line. Manifest the reality of becoming the business owner you aspire to be, and watch as those dreams begin to materialize. Lanie and Renee are thrilled to have launched Queen Creek Soft Play and are grateful to share their journey with their GoDaddy colleagues, having spoken their vision into existence together.

Are you enjoying this series and want to know more about life at GoDaddy? Check out our GoDaddy Life social pages! Follow us to meet our team, learn more about our culture (Teams, ERGs, Locations), careers, and so much more. You’re more than just your day job, so come propel your career with us.

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Keysight’s CSR summer intern has been experiencing firsthand the role of volunteerism in corporate citizenship, culture, and employee engagement. Read what she has to say about her learnings this summer in helping support community engagement and employee volunteerism.

My love of volunteering began in high school. Spending my time helping other people and working towards a mission was the first time I believed I was making a positive impact in the world. I was finally working towards something that was much larger than myself.

This love of volunteering eventually grew into an interest in non-profit work. I wanted to know how things functioned and unpack the inner workings of what makes programming possible. Through that process, I became fascinated by the intersection of business, impact, and society, so it came as no surprise that I found myself in Corporate Social Responsibility (CSR) this summer. I first learned about CSR in one of my college classes, and I knew immediately that it was a space I wanted to explore.

Corporate Support of Employee Volunteerism

CSR is an integrated business framework that manages and tracks a company’s impact on society across environmental sustainability, positive social impact, and ethical business governance, with accountability to stakeholders. For Keysight, CSR is embedded into the Keysight Leadership Model, which defines how the company operates. Keysight’s CSR program is structured across six foundational pillars: ethical governance, the environment, responsible sourcing, people, communities, and solutions.

My role this summer primarily focused on the “communities” pillar, which touches on supporting charitable and educational organizations and participation in local and global volunteer efforts. One of my projects for the summer was to put on a community engagement event to encourage volunteerism and test some of Keysight’s resources that make volunteering possible.

Supporting employee volunteerism is good for companies, communities, and employees. According to Jessica Rodell of Harvard Business Review, “many studies have shown that volunteer programs boost productivity, increase employee engagement, and improve hiring and retention.”1 Keysight recognizes that companies play a role in the prosperity of local and global communities, so it is important for the company to play an active role in supporting, uplifting, and investing in the communities in which Keysight does business. Such engagements not only help accomplish these goals but also brings great benefit to the employees themselves.

Win: Win: Win

Before exploring different community engagement ideas, I wanted to identify a group of employee volunteers that may be interested. I quickly landed on the other Keysight interns at the site. I believed that having the interns participate in a community engagement event would not only foster teamwork and camaraderie, but also give an opportunity for the interns to impact the community they called home for the summer.

After circulating through different options and getting feedback from the interns, it was clear a science, technology, engineering and math (STEM) education volunteer event aligned with the needs of the community and the interests of the volunteers. To put together this event, I turned to the Keysight’s After School program.

Keysight After School has several hands-on experiments that teach students about certain STEM subjects from electronics to physical and earth-sciences. Keysight fully funds the program’s experiment kits and its delivery by employee volunteers, at no cost to the host organizations or participating students.

After a month of planning, I finally had everything set-up for the event. I decided to go with one of the most popular STEM kits, the Solar Racer Kits, for students to build. The volunteers were set to go, and sooner than later, a local summer school made their way over to the Keysight Colorado Springs office to learn more about solar energy. In total, we had 13 students ranging from 6-12 years old and 15 intern volunteers. The volunteers assisted in building the solar racer cars with the students while teaching them about solar energy. After building the cars, the kids had some time to decorate and personalize their own special racers. After a day of learning and building, we finished our day by racing the cars outside. The students were able to take their cars home and continue their learnings of solar energy.

The impact of this event was clear. One volunteer shared that she loved watching the kids get excited about science and could see her younger self in them. Another volunteer noted, “The Keysight Volunteer event was a meaningful journey back to my roots as a former STEM camp volunteer. Teaching STEM to kids and engaging in hands-on experiences with them was both unique and unforgettable.”

It was a win all around. The students were able to engage and learn about STEM in a fun and interactive way; the interns were able to share their love of STEM and give back to the local community; and Keysight contributed to their key impact goal of engaging the future generation through STEM education.

A Full-Circle Moment

Putting together this volunteer experience was a very full-circle and fulfilling moment for me. For the first time, I was on the side of planning and heading up a volunteer event. I learned so much about certain internal processes in putting on an event like this. I also saw the power of volunteering in action. The volunteers were able to share their love of STEM with the future generation, and the kids had a fun day learning and engaging with STEM subjects. The best part was seeing the impact that this event made on both the kids and the volunteers.

My experience at Keysight taught me so much about the role of CSR and the intersection of business and society. The volunteer event affirmed for me my passion for impact-oriented work. I’m excited to apply everything that I have learned to my future endeavors and my commitment to making resources both accessible and approachable.

Sources:

1 “Volunteer Programs That Employees Can Get Excited About,” Harvard Business Review, January 2021.

Through a partnership with Convoy of Hope, we’ve been able to support communities across the U.S. in their recovery following natural disasters.

More than 200 truckloads have been donated so far this year through this American faith-based nonprofit organization, which provides food, supplies and humanitarian services to impoverished or needy populations throughout the world. The deliveries included over 21,000 products, including Pine-Sol, Clorox bleach and assorted wipes, Kingsford charcoal and pellets, and Hidden Valley Ranch dressing products. They were sent to places recovering from disasters such as hurricanes Beryl and Debbie; wildfires in California and New Mexico; flooding in the Midwest and Southeast U.S.; and tornadoes in Arkansas, Florida, Oklahoma, Iowa, Texas, Indiana, Michigan, Tennessee, North Carolina, South Carolina, Georgia, Alabama, Kansas, and Louisiana.

Recipients of these products, often located in rural areas and in desperate need of supplies after disasters, can’t afford them. Through this partnership, we were able to give people in these communities access to basic cleaning supplies, cooking products and more — reinforcing our IGNITE strategy of delivering purpose-driven growth that not only maximizes economic profit but also makes a meaningful, positive impact on the world around us.