Currently browsing "Compliance Training"
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Exploring Innovative Solutions and Trends for Electronic Records and Signatures
In the fast-evolving world of life sciences, maintaining compliance with regulations is a perpetual challenge. One such pivotal regulation, 21 CFR Part 11, shapes the electronic records and signatures landscape for pharmaceutical, biotechnology, and medical device industries. In a newly released whitepaper, “Navigating 21 CFR Part 11: Solutions for Current Challenges and Future Trends,” organizations […]
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21 CFR Part 11 Compliance in the Pharmaceutical Industry
The pharmaceutical industry operates in a highly regulated environment to ensure the safety and efficacy of drugs. Central to this regulatory framework is 21 CFR Part 11 compliance, a critical aspect that pharmaceutical companies must prioritize. Code of Federal Regulations (CFR) sets the guidelines and standards that companies in the industry must adhere to, making […]
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An In-Depth Analysis of FDA 21 CFR Part 211 Compliance in Drug Manufacturing
The pharmaceutical industry is a highly regulated sector where the standard of quality is most critical and must be adhered to. One of the key regulatory frameworks governing pharma manufacturing is the FDA 21 CFR Part 211, which outlines Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals. This set of regulations is crucial to maintaining […]
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Ensuring Data Integrity: A Comprehensive Guide to GxP Compliance in Regulated Industries
In the rapidly evolving landscape of life sciences and regulated industries, adherence to Good Practices (GxP) standards is critical to ensuring the safety, efficacy, and quality of products and services. Among the important parts of GxP compliance are 21 CFR Part 11 and EU Annex 11, guiding principles for electronic records, electronic signatures, and computerized […]
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Efficient Compliance Training In the Pharmaceutical Industry: Features You Want
Few industries exist that are monitored for compliance awareness, as much as the pharmaceutical sector. Every day different characteristics are changed regarding specific painkillers, anxiety medication, and other controlled prescription drugs. Because employees are trained to follow certain protocols on different brands of medication, when regulations surrounding a medicine are altered, the employee training must […]
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HIPAA Compliance Training and the Modern LMS: Keeping Your Healthcare Staff Up to Date
Nothing is worse than hours of endless compliance training, seminars, and mandatory meetings to “learn” about the latest rules and guidelines of HIPAA compliance and other topics. It’s an exhausting topic to have to understand and yet, there are different ways to approach it that can often take that sense of dread and boredom out […]
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How Microlearning Can Help Compliance Training
In our current world, everyone seems to be too busy with everything. People are too busy with work to get things done at home, and people are too busy with tasks at work to learn or train. This is a recurring theme that seems to keep most members of the workforce in a continuing cycle […]
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Common Compliance Training Problems
Compliance training doesn’t tend to be the most exciting type of training out there, but it is critical to the proper running of an organization. Unfortunately, compliance training can be dry and difficult for employees to understand if not delivered the right way. This is bad news because compliance training is so critically important that […]