Aseptic Processing Competencies

With regulatory agencies focusing on aseptic processing, many Life Sciences organizations are taking extra steps to define and assess the skills of those working in aseptic manufacturing.

Aseptic Processing Essentials

Aseptic processing includes sterilization of products as well as any component, container, and closures. Companies that manufacture sterile products must ensure that the production workforce is aware that a high-quality and controlled environment must be in place to prevent potential microbiological and particulate contamination.

Audit & Inspection Readiness

For companies that are seeking to enter North America markets, UL's Audit and Inspection Readiness solutions span a wide range of programs.

Clinical Site Qualifications

Sponsors often struggle to qualify global investigators and study staff with protocol and non-protocol education, while accelerating study startup times and minimizing costs. The key to success is “embedding” clinical qualifi cation into the clinical IT infrastructure, so that site managers gain visibility from the clinical systems they use most often

Commercializing Companies Best Practices

UL has established six elements of a learning and compliance infrastructure for commercializing companies.

ComplianceWire Compliance Management for Life Science Organizations

ComplianceWire is the life science industry's first choice in part 11 compliant learning management systems. Learn how more than 36,000 investigators train to meet FDA standards.

ComplianceWire: Talent and Competency Management

This suite enables standardized performance appraisal programs across all employees and helps managers focus on skills development and competencies of their direct reports.

Data Integrity Solution

The UL Data Integrity program includes a knowledgeable network of professionals to assess your organization’s current data integrity practices, identify risks and make sustainable improvements.The program enables our clients to make changes to key procedures and processes that impact data integrity, including an evaluation of technology used throughout your GxP environment.

Dietary Supplements Essentials

Aseptic processing includes sterilization of products as well as any component, container, and closures. Companies that manufacture sterile products must ensure that the production workforce is aware that a high-quality and controlled environment must be in place to prevent potential microbiological and particulate contamination.

Ethics Learning for a Mobile and Global Workforce

The EduFlex format creates interactive mobile-friendly eLearning courses to help busy and on-the-goal training participants meet the serious responsibility of ethics in a global workforce.

FDA QSIT Essentials

FDA’s Quality System Inspection Technique (QSIT) program was developed to ensure thorough coverage of the Quality System Regulation (21 CFR Part 820), while also ensuring consistency of inspections.

HR Compliance Essentials

The Quality & Compliance Essentials set enables organizations to gain affordable access to five of the most popular courses in our HR Compliance Library.

IT Validation Essentials

More than 200 QA, IT and GMP training teams currently rely on UL’s IT Validation courses to deliver “foundational” system validation training to employees within IT, QA, Operations, Management and more.

Learning Management Strategy Solutions

More than 400 companies trust UL experts to help their teams build their learning management strategies. We have worked on all aspects of learning management, from crafting a governance model to consolidating data into a single learning management system.

Learning Management Strategy Solutions for M&A Integration

It's up to the HR, QA and Learning teams to improve culture, productivity and performance following the M&A. What these teams need are approaches to integrating learning and development strategies, content, processes and systems to achieve these outcomes.

Market Entry Solutions

Learn more about UL’s Market Entry Solutions, which rely on proven processes, formulated by global experts who have successfully launched many Life Sciences products into the US marketplace. We provide a combination of onsite consulting and hands-on mentoring to support your organization’s journey through the process.

Medical Device Clinical Research Essentials

Clinical Research has become a global activity. As medical device companies enter new markets, they must continue to educate their study teams on pressing clinical topics, including Good Clinical Practices. Further, as sponsors engage clinical researchers from around the world, they need to qualify these sites and deliver GCP education.

Pharmaceutical Inspection Readiness Essentials

More than 200 QA and GMP training teams trust UL’s GMP Inspection Readiness courses to deliver “foundational” inspection awareness training to employees within QA, operations, management and more.

Pharmaceutical Clinical Research Essentials

Clinical Research has become a global activity. As pharmaceutical and biotech companies enter new markets, they must continue to educate their study teams on pressing clinical topics, including Good Clinical Practices. Further, as sponsors engage clinical researchers from around the world, they need to qualify these sites and deliver GCP education.

Quality and Compliance Essentials

The first step in compliance training is an affordable and convenient eLearning solution that some organizations have shown saves tens of thousands of dollars in development and expenses. Build your training foundation with the essentials.

Skillsoft Partnership

UL Compliance to Performance is a reseller of Skillsoft content. Skillsoft is one of the world's leading cloud-based learning and performance support resources, and focuses on a number of enterprise-wide knowledge and skills

UL Enterprise LMS

The UL L&D Platform consists of modular applications that focuses on employee performance, role-based qualifications, skills-based development, and analytics reporting so that management can quickly make decisions on learning results. The platform enables you to standardize your organization’s learning & development across all areas: sales, operations, R&D, quality, and more.

UL and Veeva Systems’ Integration Bolsters Quality and Compliance

The new Veeva Vault QualityDocs integration automatically alerts ComplianceWire® when there is new content that requires training and notifies applicable personnel with the appropriate action.

UL Health Care Knowledge Solutions

Health care companies face many business performance and compliance challenges. See the many ways UL consulting services and curricula can improve productivity and reduce noncompliance risk.

UL's Partnership with the FDA

UL and the FDA have a longstanding partnership through the FDA’s Cooperative Research and Development Agreement (CRADA). Learn more about this deep and enduring relationship.

UL's QMS Audit Program

After performing a series of adhoc audits of suppliers or internal systems, many Life Sciences companies strive to build a long-term, strategic audit focus. The UL QMS Audit program provides both the process and expertise clients need to build a sustainable audit program for the supplier network and for internal operations, delivering a measurable impact on quality and compliance consistency.

Validation and Governance Solutions

UL Compliance to Performance helps companies prepare governance models as well as validation activities more efficiently. Our team can provide detailed templates, scripts and support to help your team meet your validation and corporate governance requirements, thus streamlining your validation effort, and at the same time ensuring that you’ve incorporated current industry best practices. Having a solid validation and governance structure, based on a risk-based approach, can ensure that systems deliver the business value your company expects.

Vendor Credentialing Essentials

More than 100 Medical Device companies trust UL Compliance to Performance’s vendor credentialing courses to deliver Healthcare Industry Representative (HCIR) training to sales and field service personnel, so they can meet healthcare facility credentialing requirements.