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CEI LabForce Partners with Red Nucleus

CEI LabForce has partnered with Red Nucleus to provide online training courses for lab technicians in the Arizona Biosciences sector. These courses cover a range of topics including laboratory safety, techniques, and quality control, and are designed to help lab technicians gain the knowledge and skills they need to be successful in their careers.

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Lab Technician Courses to Grow Your Teams Knowledge

CEI LabForce and Red Nucleus have partnered to continue to support the Arizona Biosciences industry through out the state. CEI LabForce is fully committed to training lab technicians and other career positions to support the ever growing bioscience sector. Red Nucleus is a company that provides online courses for lab technicians. These courses are designed to help lab technicians gain the knowledge and skills they need to be successful in their careers. The courses cover a wide range of topics, including laboratory safety, laboratory techniques, and quality control. One of the benefits of taking a Red Nucleus course is that it is convenient and flexible. The courses are all online, so lab technicians can complete them at their own pace and from the comfort of their own homes or offices. This makes Red Nucleus courses an excellent choice for lab technicians who want to learn new skills or refresh their knowledge, but may not have the time or resources to attend in-person training.

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Course Descriptions

The Introduction to GxP module provides a summary of the rules, regulations, and guidelines that companies must follow when they research, manufacture, and market therapeutic products.

The Introduction to Good Clinical Practices module provides an overview of the rules, regulations, and guidelines that companies must or should follow during clinical trials to ensure the protection of human participants.

The Designing & Conducting a Clinical Trial module will provide you with a detailed overview of how trials are conducted, the different phases of a clinical trial, and the roles/functions needed to carry out a clinical study. 

The Clinical Responsibilities for Regulatory Submission and Compliance module is an overview of the roles and responsibilities the clinical team has in ensuring compliance for key deliverables that will need to be reported in regulatory submissions.

The US Food and Drug Administration (FDA) and other global health authorities follow a simple mantra: “If you didn’t write it down, it didn’t happen.” Good Documentation Practices (GDocP) span the entire life cycle of a drug—from discovery to commercialization. Therefore, GDocP is a critical portion of the process, inclusive of document authoring, change control, access, and archiving. The Good Documentation Practices module summarizes standard practices for good clinical documentation.

Pharmaceutical products are sold globally, but did you know that while the Aspirin you take in the US is the same as the Aspirin people take in Japan, the way the product is researched, moved through the clinical trials process, and approved for market could be vastly different from one country or region to another?

Clinical trials represent a complex web of processes, players, and human participants. Ensuring that you have the right people with commensurate experience to conduct clinical studies is critical to ensuring trial outcomes are met and human participants are protected. The Clinical Trial Roles and Responsibilities module will give you a detailed overview of the required roles, the required experience of staff, what each role is responsible for, and why it is important.

This module, “Investigator Responsibilities and IRB Review,” is an overview of the roles and responsibilities of investigators, delegates, and the Institutional Review Board (IRB) in ensuring compliance with regulatory guidance’s and human participants’ protection in clinical investigations.

Writing standard operating procedures (SOPs) is a required function of all clinical studies. Ensuring your SOPs are comprehensive, easy to understand, and concise is a difficult task which few have mastered. This module, Writing GCP-Compliant SOPs, presents a unique role-play approach to help you learn key elements of SOP identification, authoring, and improvement. You will learn the full journey of an SOP, and receive an interactive view of “best practices” for SOP development.

There are tools clinical trial professionals can use to investigate issues, find the root cause of errors, and determine the corrective and preventive actions (CAPA) to ensure mistakes aren’t repeated. Furthermore, global health authority regulations and guidance require and outline steps to ensure mistakes don’t happen, because people’s lives often depend on it.

As with any regulated industry, clinical trial professionals can expect scheduled—or unannounced—inspections from health authorities. Being prepared for these inspections is critical, because you cannot say no, and there are legal and fiscal ramifications. Internal audits and established processes will help ensure you are ready for that surprise visit, and the Clinical Audits and Inspections module will show you how.

In a modern world, we increasingly rely on technology to store data and documents. This is especially true for clinical studies. Global health authorities offer mandates and guidance related to how data and documents are derived and stored. This is inclusive of software systems used to house this information. The Data Integrity, Electronic Records, and Clinical Data module will help you understand the compliance landscape and offer best practices to ensure robust documentation and data controls.

“Expect the unexpected” is an often-heard phrase. In a clinical trial, despite all the data and planning, unexpected adverse events (AEs) can occur. When AEs happen, it is incumbent on clinical sponsors, vendors, healthcare providers, study staff, and even study participants to report this data. Because processes for reporting AEs are required, the Clinical Trials—Adverse Events module will give you an overview of the regulatory requirements, best practices for setting up robust AE reporting systems, and the relevant reporting repositories.

The terms “quality” and “risk management” are hot topics among pharmaceutical companies and regulators. In an ongoing effort to ensure human participant protection in clinical studies, the industry has worked with regulators to establish “Quality by Design” parameters that help clinical study staff ensure trials mitigate risk and achieve endpoints.
The Clinical Quality Management, Risk Management, and Sponsor Responsibilities module will focus on the sponsor’s responsibilities concerning the quality risk management of a clinical trial while offering strategies to avoid risk and improve outcomes

Like much of our global economy, life sciences companies are increasingly outsourcing certain functions, and clinical research is no exception. Contract Research Organizations (CROs) have become an increasingly visible part of the drug development landscape, as sponsor companies leverage outsourcing partners to manage and conduct studies. Ensuring you pick the right partner to help with such an important part of product development is critical, especially when clinical studies are fraught with risk. Sponsors must chose a CRO which has all the qualities, skills, resources, and experience needed for the specific needs of your study. Furthermore, regulatory requirements mandate that sponsors take the proper steps to select, qualify, and contract their CROs. The CRO Selection, Qualification, and Contracting module will outline how this happens. 

In the life sciences, sponsor companies are always ultimately responsible for the management and compliance of their CROs when conducting clinical studies. Regulations and guidance from global health authorities and trade organizations dictate what sponsors must do to oversee the actions of their CROs. The CRO Oversight Best Practices module will walk you through the requirements, processes, and best practices for CRO management.

One of the most critical parts of running a safe, effective clinical study is the monitoring of trial data, documents, and activities. Recent thinking and improvements to these processes has trial staff taking a risk-based approach to clinical trial management. At the heart of this is quality risk management (QRM). As defined by regulators, quality risk management is “a systematic process for the assessment, control, communication, and review of risks associated with the planning and conduct of clinical trials.” This Monitoring and Quality Risk Management module will provide you with an overview of the necessary steps to design QRM into your trials, the elements of a risk-based clinical monitoring plan, and provide steps for implementation.

Despite your best-laid plans, deviations from your study protocols—caused by study staff or participants—will happen. Health authority mandates state that you need to document and investigate most deviations and come up with corrective and preventive action plans (CAPAs). Your deviation investigations may involve “root cause analysis” (RCA), as it represents a useful set of tools to allow you to find the cause of a deviation and provides a road map to an effective CAPA. The Root Cause Analysis and Introduction to the Corrective and Preventive Actions Process module will outline the necessary steps to initiate an investigation when you need one and set you on the path toward corrective action.

The Corrective and Preventive Actions (CAPA) —Planning, Implementing, and Measuring Effectiveness module will walk you through the critical steps necessary to determine the correct CAPA, implement your subsequent action plan, and work toward follow-up of your implemented plan. 

The Practice Inspection module will take the learner through an interactive journey through a “mock” inspection, using a scenario and questions to determine the best course of action. A “refresher” is offered at the beginning to help learners address the scenario, while feedback is offered throughout the exercise.

Our Top Life Sciences Enrolled Courses:

Introduction To GCP

The Introduction to Good Clinical Practices module provides an overview of the rules, regulations, and guidelines that companies must or should follow during clinical trials to ensure the protection of human participants.

Designing & Conducting a Clinical Trial​

The Designing & Conducting a Clinical Trial module will provide you with a detailed overview of how trials are conducted, the different phases of a clinical trial, and the roles/functions needed to carry out a clinical study. 

Writing GCP-Compliant SOPs

This module, Writing GCP-Compliant SOPs, presents a unique role-play approach to help you learn key elements of SOP identification, authoring, and improvement.

CRO Oversight Best Practices

One of the most critical parts of running a safe, effective clinical study is the monitoring of trial data, documents, and activities. Recent thinking and improvements to these processes has trial staff taking a risk-based approach to clinical trial management.

Clinical Audits and Inspections

As with any regulated industry, clinical trial professionals can expect scheduled—or unannounced—inspections from health authorities. Being prepared for these inspections is critical, because you cannot say no, and there are legal and fiscal ramifications.

Monitoring and Quality Risk Management

One of the most critical parts of running a safe, effective clinical study is the monitoring of trial data, documents, and activities. Recent thinking and improvements to these processes has trial staff taking a risk-based approach to clinical trial management.

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