Advisory Services

Gain Access to Industry Experts

UL Compliance to Performance provides first-hand guidance on the latest regulations and perspective on industry trends, particularly for Life Sciences organizations. Our team has worked with the FDA since 1999 to co-develop the Agency's online university, including the development of 120 regulatory courses. Our experts focus on many Critical to Quality subjects such as Learning Management Strategy, Risk Management, Sterile Manufacturing, IT Validation, and many other topics.

Our Advisory Solutions team can help you meet your organization's unique needs, from preparing for – and responding to FDA Audits, Inspections and Actions, to embedding a risk management approach within your design controls process.

  • FDA Audit/Inspection Readiness:

    FDA is increasing both the number and intensity of its inspections, using a risk-based approach.  Activities such as mock audits, gap analysis, critical process reviews and inspection-readiness training are key to maximizing your preparedness.

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  • Computer Systems Governance and Validation:

    FDA has clearly defined system validation regulations described in 21 CFR Part 11. During inspections, your electronic systems will be scrutinized for compliance to these regulations. Activities such as validation of new systems or remediation of existing systems to identify gaps can greatly reduce your compliance risk during an audit. 

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  • Responding to FDA Enforcement Actions:

    Our experts will help you respond appropriately to 483s and FDA Warning Letters to help QA teams remediate issues and build programs that prevent future observations.

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  • Risk Management:

    We can help your organization minimize quality and compliance risks via a number of services, such as ISO 14971 consulting, training matrix development, and corporate compliance programs.

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SOLUTIONS

  • Have our experts help you achieve your regulatory and operational excellence goals by developing your training matrix, adding risk management to your current GxP processes, writing your governance procedures, or preparing your team for external audits.

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  • Learn why more than 450 companies worldwide rely on ComplianceWire®, our award-winning LMS, to cost-effectively provide online regulatory and compliance training programs. 

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  • Leverage our combined web-based platform and Learning Services team to create a customized and cost-effective solution that delivers and tracks content to a targeted global community of non-employees such as physicians, clinicians, suppliers, distributors, regulators and more.

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  • Our clients save training course development time by using our 500+ standard online courses, which are written by industry experts, and can be customized to meet your needs.

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