Risk-based Monitoring (RBM) is a practice embraced by industry and global Health Authorities. Educating and supporting current resources is a significant challenge for sponsors/CROs and investigation sites and has been a root cause of weak ineffective study start-up efforts. This course will help you train staff to ensure robust RBM activities and ensure success.
Six Sigma is a well-known certification within the manufacturing world, but it’s concepts and practices that can easily be applied to routine activities in clinical research. This course will introduce you to several tools that have been recognized in Six Sigma certification training. The curriculum will demonstrate how simplified, modified versions of these tools are already in use, and guide you on identification and use. Upon completion, you will have actionable, practical Six Sigma tools to bring to bear on your clinical operations – from Sponsor to Site.
Attend this live webinar, to learn from recognized industry experts about the DIGR-ACT® Solution – an exciting methodology for supporting critical thinking in risks and issues management specifically designed for the clinical trial professional.
In March 2019, FDA released a new draft guidance titled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers” which helps support the 2013 “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” (RBM) guidance. This new draft guidance is currently open for comment and further underscores FDA’s emphasis on clinical studies being overseen using risk-based techniques. This session will illuminate FDA’s thinking and help you prepare.
Disinfectant efficacy testing is utilized to measure the effectiveness of chemicals that are used clean, sanitize, or disinfect surfaces. Understanding the importance of testing and proper use of disinfectants is essential in avoiding regulatory findings. This webinar will review the essentials of disinfectant efficacy testing.
Many small to mid-sized biotech and pharmaceutical companies possess exciting science, promising products, and endless opportunity. However, most lack the kind of robust clinical Quality Management Systems (QMS) required by global health authorities. Since patients and profits are at risk, it is critical to establish these systems for market approval and patient safety. This course will give you the necessary tools to establish a working and compliant QMS for your business.
In March of 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) released the “‘GXP’ Data Integrity Guidance and Definitions” guidance document, which outlined the agency’s thinking on data integrity best practices. In October of 2018, FDA and MHRA held a joint GCP (Good Clinical Practices) Data Integrity Workshop, where the agencies clarified their expectations for data integrity in clinical studies and identified key risk areas using case studies and agency observations. This course will give you a baseline for data integrity requirements, and overlay lessons learned from the FDA/MHRA workshop.
This course will explore areas within the life sciences where early adoption is a possibility. A vendor-neutral review of current Blockchain software platforms and their potential fit within your organization will be provided. Finally, you will receive instruction on how to identify and execute the steps necessary for determining if Blockchain is applicable to your function within your organization.
This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research. Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.
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