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2 Day FDA Pharma & Biotech Computerized Systems Validation, Data Integrity & Cloud Computing Webinar: Explore Compliance Strategies for COTS and Cloud Software (ONLINE EVENT: July 2-3, 2025)
2 Day FDA Pharma & Biotech Computerized Systems Validation, Data Integrity & Cloud Computing Webinar: Explore Compliance Strategies for COTS and Cloud Software (ONLINE EVENT: July 2-3, 2025)

Yahoo

time5 days ago

  • Business
  • Yahoo

2 Day FDA Pharma & Biotech Computerized Systems Validation, Data Integrity & Cloud Computing Webinar: Explore Compliance Strategies for COTS and Cloud Software (ONLINE EVENT: July 2-3, 2025)

Join our comprehensive webinar on agile vs. waterfall methodologies for system validation, including FDA compliance insights! Discover strategies to modernize your System Development Life Cycle and ensure data integrity with CSA, GAMP®5, SDLC, COTS, SaaS, IaaS, and PaaS insights. Register now! Dublin, June 25, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech" has been added to offering. The seminar will take an in-depth look at commercial software options like COTS, SaaS, IaaS, PaaS, and other cloud services. It will examine the benefits and risks of these models while detailing best practices for compliance with FDA validation requirements, including 21 CFR Part 11 and data integrity. Attendees will get insights into the FDA's current stance on technology and compliance expectations. As technology continues to advance, organizations are transforming to meet increasingly informed and demanding customer needs. To maintain a competitive edge, work practices and tools require adaptation. This seminar will explore methods for developing software, validating performance, and maintaining alignment with evolving business models. Highlighting both agile and waterfall methodologies, the session will compare their advantages and limitations in maintaining validated systems throughout their lifecycle. Learn how to leverage cutting-edge technology for FDA compliance, focusing on modernizing the System Development Life Cycle (SDLC) via a risk-based CSA approach using agile methodologies. This includes utilizing automated testing tools to enable continuous software validation. The approach aligns with GAMP5, Second Edition methodologies, ensuring compliance and operational success. Participants will also gain insights into data privacy regulations like HIPAA and GDPRs. Additionally, the discussion will cover best practices for COTS software, SaaS, and other cloud services, guiding attendees in making informed decisions on contracts and Service Level Agreements (SLAs) to suit organizational needs. Spreadsheet validation will also be addressed, equipping participants with efficient strategies to manage customizations and ensure compliant data handling. This immersive in-person seminar promises interactive discussions that encourage attendees to bring forth their most pressing challenges and pain points related to validation, fostering problem-solving sessions. Key Topics Include: Identifying and applying FDA regulations on GxP systems Updating CSV approaches for compliance with FDA requirements Modernizing SDLC with agile approaches and automated testing Optimizing cloud services and validating without quality compromise Documenting validation efforts for both agile and waterfall methodologies Maintaining data integrity through an agile validation approach Understanding new trends in FDA compliance 12.0 RAC CREDITS RAPS - Eligible for up to 12 credits for RAC recertification upon full completion. Webinar Benefits for Attendees: 2-Day CSV Training Session Downloadable presentation slides Certificate of participation Q&A Session Free handouts on CSV Who Should Attend: Information Technology Analysts Information Technology Developers and Testers Software Quality Assurance Professionals QC/QA Managers and Analysts Analytical Chemists Compliance and Audit Managers Laboratory Managers Automation Analysts Manufacturing Specialists and Managers Supply Chain Specialists and Managers Regulatory Affairs Specialists Regulatory Submissions Specialists Risk Management Professionals Clinical Data Analysts Clinical Data Managers Clinical Trial Sponsors Computer System Validation Specialists GMP Training Specialists Business Stakeholders/Subject Matter Experts Business System/Application Testers Vendors responsible for software development, testing and maintenance Key Topics Covered: Day 1: Module 1: CSV Methods and Models Module 2: Software and Services Module 3: CSV Planning Module 4: System Requirements and Design Module 5: IQ, OQ, PQ Test Planning & Execution Module 6: Test and Validation Reports Day 1 Q&A Session Day 2: Module 7: CSV Operations and Maintenance Module 8: CSV Supporting Components Module 9: Managing FDA-Regulated Data Module 10: Vendor Audit Module 11: FDA Trends Module 12: Inspection Preparation Day 2 Q&A Session Module 13: CSV Exercises Speakers: Carolyn Troiano: Webinar/Seminar/Workshop Instructor in FDA Compliance Training Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio

How Marketing Teams Can Implement AI Successfully
How Marketing Teams Can Implement AI Successfully

Forbes

time13-06-2025

  • Business
  • Forbes

How Marketing Teams Can Implement AI Successfully

Andrea Fryrear is CEO and cofounder of AgileSherpas, a leading consultancy for building modern marketing operations that are AI-ready. Marketers are widely acknowledged to be among those greatly affected by AI, which has made many of us race blindly into haphazard adoption. While some action is usually better than none, marketers risk disrupting their already chaotic processes if they don't approach AI strategically. At my company, we've been asking marketers around the world about how they get work done for eight years now. But this year, we decided it was time to really dive into AI for the first time. What we found in our State of Agile Marketing Report is that one group of marketers was more likely to have adopted AI and see positive results. Peeling back the layers, we learned there's a clear set of agile practices, mindsets and approaches that can increase marketing teams' likelihood of productivity, prioritization and AI adoption. My company provides agile training for marketing teams, and I believe the lessons we learned this year can be used to inform how businesses approach work management, even outside of marketing. Today, the pressure to adopt and integrate AI into business processes can be overwhelming. It's no wonder that our report found only 7% of the 430 marketers surveyed said they weren't considering AI at all. But, despite the fact that 93% of marketers want to integrate AI, only 17% have fully worked it into their marketing processes. So what's stopping them? First, they're overwhelmed by an endless number of AI tools. From 2023 to 2024 alone, the number of marketing technology products increased by more than 27%, with many of those solutions featuring AI. I've learned through conversations with marketers that many are also concerned about compliance and wondering how to approach the AI integration process. It can all feel like trying to drink from a firehose, except the firehose itself is also moving, and there's a big timer letting them know they need to finish drinking before their competitors do. But despite these challenges, some teams are figuring out how to turn that firehose where they need it to go. One of the most surprising takeaways from our report was how much a team's level of agility could impact their ability to fully integrate AI. "Fully agile" teams were more than three times as likely to have done so compared to their less agile counterparts. This aligns with 2021 research from McKinsey, which found that "highly successful agile transformations" led to improvements in efficiency, employee engagement and operational performance, as well as "turbocharged innovation." But besides agility, what practices enabled marketers who called themselves "extremely successful" with AI adoption to excel? We found they had more leadership support and agile training, focused on fewer high-value activities and enjoyed greater autonomy. This environment enabled these marketers to rigorously test and experiment with AI. Instead of simply adopting whatever AI tool their leaders told them to, greater autonomy enabled marketers to figure out what worked for them. As a result, we saw those higher AI integration rates. This tells me that giving teams the tools and culture they need to solve as complex a problem as AI integration really makes a difference. Knowing that agile, autonomous and supported marketing teams can perform in all these ways is great, but what about knowing how to unlock those benefits? We asked how people educated themselves about agility, and many respondents used free and paid self-paced video learning, agile certification courses, written content, attended conferences and worked with coaches. However, leaders can go beyond this. I recommend: The bigger takeaway for leaders is that while agile practices are important, their foundation is always mindset. The first step to unlocking all of these benefits is to think like an agile leader. For example, instead of stepping in to directly 'help' your teams with AI adoption, figure out what tools and training they need, provide them and give them space to figure things out. Micromanagement isn't what teams need here. A part of that agile mindset is ruthlessly prioritizing your work. For AI integration, this means not letting perfect become the enemy of good. For example, accept that you're better off running a test on a tool and learning something as opposed to waiting weeks and weeks to find the perfect tool to test. The reason this is so important is that each time you experiment with a new AI tool or use case, you'll gain valuable insights. Those insights can then be applied to the next test. In my experience, the value of waiting for a better tool or use case to test rarely outweighs the benefits of gaining those insights fast, particularly in a space as fast-moving as AI. Another common hurdle leaders need to overcome is compliance. There's no getting around the reality that navigating compliance with AI is tricky, but treating compliance or legal teams as stakeholders can help. That means involving them in AI adoption early and seeking their input at a regular cadence. When compliance teams are actively involved in the AI adoption process, you get more mutual understanding. Compliance can see what challenges the teams implementing and testing AI are up against, while those teams are better able to see what compliance is trying to do. So, whether you're a marketer or not, this data shows a clear path forward. Fully integrating AI into your processes can help you remain competitive in today's landscape, but getting there requires giving teams the support they need to cultivate agile mindsets and behaviors. Once marketing teams can embrace experimentation, continuous improvement, focus and prioritization, and autonomy, they're uniquely positioned to thrive in an AI-first business environment. Forbes Business Council is the foremost growth and networking organization for business owners and leaders. Do I qualify?

Why hiring in-house might be your worst business decision
Why hiring in-house might be your worst business decision

Fast Company

time21-05-2025

  • Business
  • Fast Company

Why hiring in-house might be your worst business decision

'We doubled our marketing team, and still fell behind.' That's what one founder told me in January, frustrated after months of hiring, onboarding, and budgeting…only to lose ground anyway. In 2025, the old formula of 'more people equals more results' just isn't working. Let's face it, traditional hiring is broken. It's costly, time-intensive, and built for a world that no longer exists. Training takes months, and even the best employees can't be experts in everything. And scaling up or down? That's nearly impossible when your budget is tied to headcount. That said, full-time employees are still the heart of any great company. Their creativity, dedication, and drive are what push businesses forward. So, what is a leader to do? That's where the right agency comes in. Not to replace your team, but to amplify it. An agency partner keeps your business agile and efficient, filling in gaps without replacing your team. Instead of overloading in-house employees, an agency can bring specialized expertise exactly when and where it's needed, without adding overhead. 5 reasons to amplify your team with an agency Here's why teaming up with an agency could be the right move in 2025. 1. Access to a dream team When you work with an agency, you're not gaining just one person, you're tapping into an entire squad of experts. Need killer copy, smart SEO strategies, or top-notch data insights? They've got you covered. Building a team like that in-house takes time and money, but an agency delivers it all, with minimal onboarding. This means your employees can focus on the big picture goals while the agency handles the specialized execution that drives results. 2. Smarter spending Hiring is expensive. Salaries, benefits, equipment, training…it adds up fast. Then there's turnover— 46% of employees plan to job hunt in the next three months, and replacing an employee costs about 50% of their annual salary. That number jumps to 100% for higher-level roles. Agencies, on the other hand, come with clear, predictable costs. They're not about cutting corners; they're about making smart investments. You get the best of both worlds; high-level expertise without the financial risk of full-time hires. 3. Staying ahead of the game The marketing world never stops moving, and you must be ready to pivot at a moment's notice. Agencies, like social media-focused marketing agency Firebelly, are built for this​​. They constantly test new tools and strategies, so you don't have to. I recently spoke with Duncan Alney, founder and CEO of Firebelly Marketing, about how businesses today can't afford to fall behind. 'As a social media marketing agency, we're focused on staying ahead of the industry's trends and news. Marketing shifts too quickly, and in-house teams are already stretched thin,' Duncan shared. 'Firebelly brings the advantage of real-time insights and adaptability, things that are nearly impossible to maintain internally.' Your team can focus on longer-term growth while your agency keeps you on the cutting edge. 4. Scalability, when you need it Businesses aren't predictable. Maybe you've got a product launch coming up, or maybe it's a slow season. Agencies ramp up or scale back as necessary, taking the pressure off your team. It's like having a safety net that adjusts as you go. 5. Hit the ground running Hiring and training new employees takes time, and sometimes you need results ASAP. Agencies come in ready to go. They bring proven systems, expertise, and results. Instead of waiting months to see progress, you build momentum right away. As a marketer and business owner, I've seen firsthand how agencies can transform businesses ready to level up their marketing. The right agency can bring expertise, speed, and flexibility to the table, working alongside in-house teams. This isn't about replacing your employees, it's about giving them the support they need to shine. Before you post that next job opening, ask yourself: Could an outside partner help you achieve your goals faster and with less risk? In 2025, the smartest way to build from within might be by looking outside.

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