Clinical Research Risk Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.

Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.

This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.

This webinar will teach you how to downsize the risk of noncompliance during the development of a clinical trial by helping you to understand, correct and prevent potential protocol deviations/violations.

This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.

This training program will explain what the strengths and weaknesses of the RACT are and where it should be used with caution. It will also elaborate on what needs to be done to establish a comprehensive risk management approach to support risk-based quality management in clinical trials.

This training program will analyze the importance of research risks defined in 21 CFR 50 and 45 CFR 46. It will delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50. The program will also discuss the need for indemnification language in consent forms based on risk levels.

This training program will discuss investigator oversight and responsibilities, records management including source data, trial data handling and procedures, quality and risk management, vendor oversight and subcontracting, risk-based monitoring and last but not least root cause analyses in case of non-compliances.

This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.

This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.