Category: 3. Business

Krystle Sampani-Morales is used to people calling her “Ma’am K” – even Sandvik customers who use it affectionately when they call and ask her for help solving a variety of issues.

Sampani-Morales was recruited to Sandvik ten years ago as a customer service representative in the Philippines. She was increasingly given additional responsibility from mentors who believed in her capabilities and gave her the independence and freedom to do what needed to be done – and that is still the case in her job today.

A trusted problem-solver

Now, as the Sales Support Team Lead, Sampani-Morales is based at the Mining office in Manila but also spends some time on the road visiting customers on mining sites to clarify processes, handle parts and rock tool inquiries, ensure staff understands the contract on site, or train staff for continuous learning. She’s become something of an expert when it comes to quick problem solving, working with logistics, inventory, and warehouse teams to ensure customers get the parts they need. “I don’t know what my job description is anymore!” says Sampani-Morales, adding that she continues to learn on the job.

Prior to Sandvik, she worked in sales administration as a supervisor, handling customer orders for Johnson & Johnson. She has a Bachelor of Science degree in Computer Science from Polytechnic University of the Philippines, which comes in handy too, particularly with the Sandvik systems. Colleagues and customers rely on her regularly for system support and training.

Sandvik is very passionate about customer satisfaction, and we don’t want people to feel alone. We promote inclusivity among our team members. They should know they have processes and team support.

Sampani-Morales also appreciates the Sandvik culture of building strong, lasting relationships with its customers – and how the Filipino values are embraced locally. “We support our customers on their low days too,” she points out explaining that when one company encountered a short-term financial issue, they were met with understanding from Sandvik and an extension. “That business eventually grew and the company is today one of the best mining companies in the Philippines – and a major Sandvik customer.”

Perhaps the biggest challenge for Sampani-Morales initially was being on a mining site, something she felt nervous about at first. The strict safety regulations and thorough training at customer mines quickly put her mind at ease. Today she travels long distances to the north and south of the Philippines to gold, copper and nickel mines like Oceanagold in Luzon, Filminera in Masbate, and Apex Mining in Davao, which is nearly 1,500 kilometers from her home in Manila.

From office to mine site

Visiting a mine approximately once a month has given her invaluable insights for her role. “I have learned so much about mining and I have big respect for colleagues at the mines. After visiting mining sites, I understand why everything is so urgent. The mines are working 24/7 and if a machine is down, their production is down.”

As a hiker, surfer and nature lover, Sampani-Morales initially questioned whether mining was an appropriate field for her to work in. She soon came to realize “there is a difference between good mines and bad ones,” and was comforted by the fact that Sandvik only conducts business with the “good ones” – fully compliant customers.

“These are mining customers who prioritize and promote safety, follow all regulations and standards of the government and ensure environmental protection,” she explains. “It’s important to also understand that mining is not about destroying our environment but providing essential minerals and metals.”

Balancing career and family

Outside of work, this wife and mother of two young boys prioritizes family, and she looks forward to the day when her seven and two-year-old sons are old enough to go on the weekend hiking and surfing trips that she’s eager to resume.

Back at the office, one of the best things about the daily work is having good colleagues, she says. “We share our lunches together and laugh all the time!”

And for those considering a career within Sandvik, Sampani-Morales has some final words: “You get to be independent – and work with a team – and you learn a lot every day.”

A “lifeline” flight service between Wick and Aberdeen will resume on Wednesday after the subsidised air service stopped in October.

The previous operator, Eastern Airways, entered administration in November, forcing Highland Council to launch an emergency procurement process.

Air Charter Scotland will run the service six days a week using an 18-seat Jetstream 32 aircraft.

The local authority and Scottish government fund the public service obligation (PSO) route. Highland Council has said it is exploring the option of extending the contract to include flights from Wick to Edinburgh.

Today’s global pharmaceutical supply chain is highly interconnected and action taken by one regulator may have a global impact. This blog explores why European manufacturers and marketing authorization holders should pay attention to U.S. Food and Drug Administration (FDA) Warning Letters sent to their key suppliers — including active substance manufacturers, finished product manufacturers, or quality control laboratories — as they may materially affect authorization holders in Europe. In light of a new approach announced by the UK Medicines and Healthcare Products Regulatory Agency, we consider the European authorities’ approach to FDA Warning Letters and the potential impact for industry.

The U.S. Food and Drug Administration (FDA) may issue Warning Letters to regulated manufacturers when it identifies significant violations of federal requirements. As FDA notes, “Warning Letters are issued to achieve voluntary compliance and to establish prior notice.”¹  The agency takes the position that Warning Letters are issued only for violations of regulatory significance that would lead to enforcement action if they are not remedied. Regulators worldwide watch FDA Warning Letters as sources of insight into compliance issues.

1. MHRA’s Evolving Approach to FDA Warning Letters

Until recently, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Inspection Action Group (IAG) and Defective Medicines Report Centre (DMRC) took a proactive stance on notifying UK companies affected by FDA Warning Letters. They would “regularly receive US FDA Warning Letters (including Official Action Indicated and import ban letters) and contact UK licence holders who may be implicated,” for instance, where a contract manufacturer or active pharmaceutical ingredient (API) supplier in receipt of an FDA Warning Letter was supplying products to a company in the UK.

In August 2025, however, the MHRA announced a revised approach: The agency will not routinely notify marketing authorization holders (MAHs) in the UK about FDA Warning Letters involving their third-party manufacturers. Instead, MHRA has highlighted the responsibility of all manufacturers, wholesale license holders, and API registrants to monitor FDA Warning Letters as part of their supplier qualification and oversight programs.

In practice, MHRA expects companies to have robust procedures, such as detailed technical/quality agreements with suppliers, to ensure they learn of regulatory action as a matter of course. The onus is now on industry to “review and risk assess US FDA Warning Letters” and determine whether any action is needed on their part, mirroring the approach generally taken in the EU (see below).

The change of approach by MHRA is seen as a move to free up MHRA’s resources rather than a signal that that the monitoring of foreign regulatory action is becoming less important. Notably, if a company’s own risk assessment of an FDA Warning Letter reveals a potential impact on UK product quality or patient safety, the company should notify the MHRA. In addition, the MHRA retains the discretion to intervene or escalate matters on its own motion through the IAG, which is responsible for recommending and implementing regulatory action for breaches aross all good practices and the DMRC, which provides an emergency assessment and communication system in regard to allegedly defective medicines.

2. EU Handling of FDA Warning Letters

In the EU, an FDA Warning Letter generally does not trigger an automatic notification from authorities to the affected EU manufacturing or marketing authorization holder. Instead, license holders are expected to monitor foreign regulatory activities relevant to their activities, including FDA enforcement actions and advisory actions such as Warning Letters relating to their contractors. EU authorization holders are required to proactively evaluate any impact using the principles of quality risk management and, depending on the outcome of the risk assessment, take appropriate action. The evaluation includes notifying the European Medicines Agency (EMA) or the national authorities in case the risk assessment reveals a potential impact on product quality or patient safety, and it includes assessing whether the situation may lead to abnormal disruption in supply due to a contractor compliance situation, in which case relevant notifications should be made to the competent authorities. Action may also include performing a for-cause audit or delisting the contractor from the approved contractor list.

European authorities may also intervene directly through coordinated action in case of serious good manufacturing practice (GMP) noncompliance (issues where regulatory action is considered necessary to remove a potential risk to public health). Such process may start with information originating from third-country authorities or international organizations, including FDA Warning Letters. For centrally authorized medicines, the EMA leads the oversight and coordinates any EU-wide response. For nationally authorized products, the relevant competent authorities lead the risk assessment and actions but work closely with the other member states’ authorities to ensure a unified approach. Immediate actions may include issuing rapid alerts throughout the EU, recalling affected batches from the market, or prohibiting further supply of products from the implicated site. If warranted, authorities can issue an official GMP noncompliance statement, effectively barring the site from supplying the EU.

A notable development is that beginning October 1, 2025, the EMA may accept inspection findings by the FDA for inspections conducted outside of the U.S. under the EU-U.S. mutual recognition agreement (MRA) on GMP. This may be done voluntarily and on a case-by-case basis. Practically, this means that marketing authorization applications or variation applications may be able to rely on FDA inspections, thereby postponing the EU inspection that would normally be required during the assessments (see Q&A on impact of EU-USA MRA on marketing authorization applications and relevant variations). Applicants are encouraged to proactively contact the relevant regulatory authorities to discuss the need and timing of any potential inspections. With respect to the FDA inspection findings, an EMA Q&A indicates that to rely on the mutual recognition, the outcome of the FDA inspection should not be classified as “Official Action Indicated.”

3. Practical Considerations

For global authorization holders, the interconnectivity of the global supply chain carries important implications. The MHRA’s shift in approach is an important reminder to pharmaceutical and biopharmaceutical companies that proactive compliance monitoring and strong internal protocols are critical to remain complaint.

Key takeaways:

• Monitor FDA and other regulators’ inspections of contractors. Companies should establish a routine process to identify FDA Warning Letters and other global regulatory actions that involve their contractors. Companies cannot rely on regulators to inform them; both the MHRA and EMA expect companies to keep apprised as part of supplier oversight.
• Ensure robust contracts and technical agreements. Include clauses in agreements with contractors that require prompt notification when the contractor is inspected and prompt notification of the outcome of such inspection as well as prompt notification of communications by agencies such as FDA regarding site classification or the receipt of a Warning Letter or untitled letter. FDA typically discloses Warning Letters publicly, but the timing for publication can be delayed.
• Maintain robust internal escalation protocols. Companies should have clear, documented procedures for action if a contractor is implicated in an FDA Warning Letter, GMP noncompliance report, or similar regulatory action. Typically, the quality assurance unit would promptly initiate a risk assessment of any potential impact on the company’s activities. Based on the outcome, the company can determine appropriate actions, ranging from enhanced testing of incoming materials to qualifying alternative suppliers.

FDA Warning Letters can have a global impact, with real implications for EU and UK authorization holders. Regulators on both sides of the Atlantic share information, and they increasingly expect companies to closely monitor regulatory developments that may affect their supply chains. Vigilance over global regulatory actions, robust supplier oversight, and well-prepared internal processes are essential to prevent a warning overseas from becoming a crisis at home.

The Sidley Global Life Sciences team continues to monitor these developments closely. We are available to assist companies in anticipating and managing the EU and UK regulatory implications of FDA Warning Letters and related compliance issues.

¹FDA Regulatory Procedures Manual at 4-1-1.

In an unfortunate development for workplaces, the popular project management tool Trello is not working, reportedly, after an outage hit it just at the beginning of the work week.

As reported by users, the outage primarily affected the Trello app, which is designed to help teams track project progress through a system of cards.

Trello’s downtime began early on Monday, with users experiencing crashes and error messages. Upon refreshing, they were shown notifications such as “You are disconnected” or “We’re having trouble loading Trello.”

This disruption has left countless professionals unable to access Trello, which is primarily used on web.

Trello not working, but status update says otherwise

The interesting part is that Trello’s official status page did not indicate any active incidents, showing “No incidents reported today” and listing all systems as “Operational.” This discrepancy has added to users’ confusion regarding the outage.

Those unfamiliar should note that Trello is widely utilised in workplace settings, enabling collaborative work on various projects, but it can also be adapted for personal tasks, like home renovations.

With service downtime in place, users are advised to refrain from heavy editing, refresh their pages, and attempt to access their boards later when the service is fully stabilised.

Why Trello is not working?

The exact cause of the outage remains unclear, but Trello is expected to be back up with functionality restored for users, allowing them to resume their projects in an unperturbed manner.

The Methane Regulator-to-Regulator (MR2R) Network is a peer-to-peer platform created by the Climate and Clean Air Coalition (CCAC) and the International Energy Agency (IEA) to help fossil fuel regulators share experience, develop best practices, and strengthen methane regulation through trusted collaboration.

 

About the Network

The Methane Regulator-to-Regulator (MR2R) Network is designed for government regulators responsible for methane emissions from the oil, gas, and coal sectors. As countries implement commitments under the Global Methane Pledge and respond to rising expectations for low-emissions energy, regulators are increasingly required to design and enforce new methane frameworks, often with limited access to peers or tested regulatory models.

The MR2R Network, established by the Climate and Clean Air Coalition (CCAC) and the International Energy Agency (IEA) through the CCAC Fossil Fuel Hub and the IEA’s Global Methane Engagement Programme, provides a trusted, closed-door environment where regulators can connect, learn, and collaborate. The network complements the Fossil Fuel Regulatory Programme (FFRP) and builds on the IEA’s regional roundtables by focusing specifically on practical regulatory exchange.

Through MR2R, regulators can engage in continuous dialogue with peers at different stages of the regulatory journey, share real-world experiences, discuss challenges, and co-develop solutions to accelerate the effective design and implementation of methane regulations. The network supports regulators through activities such as annual in-person meetings, technical webinars, mentorships, panel participation, co-authored publications, and a rapid peer-support hotline, enabling members to strengthen regulatory capacity and leadership in methane abatement.  

 

About the CCAC and IEA

The Climate and Clean Air Coalition (CCAC) is a global partnership working to reduce short-lived climate pollutants, including methane, in order to protect the climate and improve air quality.

The International Energy Agency (IEA) is the world’s leading authority on global energy data, analysis, and policy.

The MR2R Network is jointly delivered by the CCAC Fossil Fuel Hub and the IEA’s Global Methane Engagement Programme. CCAC leads coordination with governments and alignment with the Fossil Fuel Regulatory Programme (FFRP), while the IEA provides technical analysis, regulatory expertise, and support through its existing regulatory roundtables. Together, they co-convene the network, support its activities, and ensure it delivers practical value to participating regulators.

CORK, Ireland, Jan. 12, 2026 /PRNewswire/ -- Johnson Controls International plc (NYSE: JCI), the global leader for smart, healthy and sustainable buildings, announces the following webcast: 

What: Johnson Controls First Quarter Fiscal 2026 Earnings Conference Call

When: Wednesday, Feb. 4, 2026, at 8:30 a.m. ET

How: The conference call for investors can be accessed in the following ways:

• Live via webcast at http://investors.johnsoncontrols.com/news-and-events/events-and-presentations Note: A slide presentation will be available that morning for downloading.
• Live via telephone (for "listen-only" participants and those who would like to ask a question) by dialing 855-979-6654 (in the United States) or +1-646-233-4753 (outside the United States) along with passcode 927389.

Replay: The replay can be accessed in the following ways:

• Replay via webcast – if you are unable to participate during the live webcast, the call will be archived at http://investors.johnsoncontrols.com/news-and-events/events-and-presentations.
• Replay via telephone – by dialing 855-762-8306 (in the United States) or +1-845-709-8569 (outside the United States), passcode 547602, from 10:30 a.m. (ET) on Feb. 4, 2026, until 11:59 p.m. (ET) on Feb. 18, 2026.

About Johnson Controls

At Johnson Controls (NYSE:JCI), we transform the environments where people live, work, learn and play. As the global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet.

Building on a proud history of 140 years of innovation, we deliver the blueprint of the future for industries such as healthcare, schools, data centers, airports, stadiums, manufacturing and beyond through OpenBlue, our comprehensive digital offering.

Today, Johnson Controls offers the world`s largest portfolio of building technology and software as well as service solutions from some of the most trusted names in the industry.

Visit johnsoncontrols.com for more information and follow @Johnsoncontrols on social platforms. 

 

 

SOURCE Johnson Controls International plc

The G7 Cyber Expert Group (CEG) – chaired by the U.S. Department of the Treasury and the Bank of England – released a public statement today advising financial entities, authorities and suppliers of key considerations and potential activities for transitioning to quantum-resilient technology in a coordinated and timely way. 

Quantum computers have the potential to revolutionize the financial sector, unlocking significant new capabilities and opportunities for organizations. This is not without risk however – sufficiently advanced quantum computers have the potential to break widely used cryptographic protocols that protect our systems and data. 

G7 CEG Co-Chairs, U.S. Treasury’s Deputy Assistant Secretary for Cybersecurity and Critical Infrastructure Protection Cory Wilson and the Bank of England’s Executive Director for Supervisory Risk Duncan Mackinnon, said: 

“The introduction of quantum computers that can break our encryption tools presents a significant risk to the safety and soundness of our financial ecosystem. This is something we must address together, and the roadmap guidance will be an important reference for organizations to consider as they prepare their systems and data to be quantum resilient.” 

The G7 CEG’s roadmap outlines several considerations for financial sector stakeholders, authorities and industry about the cryptographic risks associated with quantum computers. The roadmap and its associated timeline are not prescriptive, providing organizations with the flexibility to implement as appropriate for their unique situation. 

The G7 CEG’s membership includes representatives of financial authorities across all G7 countries as well as the European Union. It was founded in 2015 to serve as a multi-year working group that coordinates cybersecurity policy and strategy across the member jurisdictions. In addition to policy coordination, the G7 CEG also acts as a vehicle for information sharing, cooperation, and incident response.