Compliance officers need steady nerves to manage the legal and compliance risks posed by third-party intermediaries. Regardless of how well respected the third-party organization, how well written the contract, or how well established the brand company’s in-house compliance program, compliance requires effective third-party risk management. Read this paper and know the 5 critical steps in managing third-party compliance risk.
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Today, Clinical Research Organizations (CRO) and clinical service providers play an ever-increasing role across the value chain. The wave of eClinical solutions has prompted many such organizations to implement training management and qualification management programs to both employees and associated clinical research sites and physicians. Read this paper for four guiding rules for structuring an eClinical training solution.
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A Quality and Compliance Training Road Map for Emerging FDA-Regulated Companies
Emerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without compromising the entire quality program.
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Many FDA-regulated companies need to assess how their personnel demonstrate competency for assigned functions. This paper explores how an automated competency assessment can be embedded into the process training, so that follow-up actions, such as the assignment of additional training or initiating a remedial mentoring program, happen automatically. This leads to more precise training and more accurate, audit-ready records.
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Today’s volatile economic climate has many regulated companies thinking differently about cost containment within all operations, particularly through training management. Here we outline 10 value drivers that affect ROI for employee training management among regulated companies, and how they can be achieved through cloud-based training management. See how learning systems delivered through the cloud can increase your ROI.
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Standard Operating Procedures (SOPs) are critical to efficient operations, quality control, and regulatory compliance. Yet many recent FDA violations have focused on firms’ failure to properly use SOPs. This paper reviews best practices for the life science industry for training on SOPs. Specifically, how the latest learning management technology has the potential to improve learner retention through automated assessments.
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