Risk Management Training

This 3-hr virtual seminar will present an overview of new risk oversight expectations and reporting rules in place, and show how companies, risk managers and internal auditors can meet these regulatory expectations.

This webinar will discuss how to manage supply chain risk to optimize clinical trial supply and also manage demand side requirements, risk of stock out, cost management etc using novel tools and technologies.

This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.

This 3-hr training on South Korean regulatory compliance requirements for life science products will discuss about the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea.

This webinar will train you on interpreting FDA's new guidance document on risk-based monitoring. It will include a case study demonstration on how any biopharmaceutical, medical device, and CRO could leverage the applications of breakthrough techniques to implement risk-based monitoring.

This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.

This webinar will equip attendees with the knowledge necessary to efficiently design and enhance GRC activities across the organization based on established GRC standards.

This webinar provides a behind-the-scenes look at how trial lawyers think and operate. It will provide you the understanding necessary to take steps to counter the tactics of trial lawyers and also keep your businesses off the trial lawyers’ radar.

This 120-minute webinar will cover best practices and standardized processes, outlined in ISO 14971, for managing risk in medical devices. You will learn from the shared experience and examples provided by the speakers on how to implement proper and effective risk management processes and practices at your company.

This 90-minute webinar will introduce you to the components that make up today’s e-Banking services. It is also a precursor, for those unfamiliar with it, to further modules focusing on understanding the risks associated with e-Banking, as well as the compliance challenges we face.

This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial.

This 90-minute webinar will provide you a thorough understanding of the updated framework surrounding Good Pharamcovigilance Practices (GVP) in the EU. This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation.

This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.

This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.

This webinar on Federal Campaign Finance Law will assist compliance officers and in-house counsel identify common campaign finance issues faced by corporations and trade associations in major election years.

This webinar explains the application of Risk Management for medical devices using ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report, looking at important terms including Hazard, Harm, and Risk and explaining how to use each one. The program describes development of a Risk Evaluation form that implements the requirements of ISO 14971.

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.

Grasp the intricacies of managing third-party vendor due diligence in line with SEC regulations with our targeted webinar. Explore the essentials of Third-Party Management, identify potential risks, and learn how to safeguard your investment advisory firm from regulatory pitfalls. This session is indispensable for RIAs aiming to fortify their vendor management protocols and stay compliant with evolving SEC guidelines.

Navigate the complexities of SEC cybersecurity regulations with this focused 90-minute webinar. Gain insights into compliance strategies, understand the implications of non-compliance, and enhance your firm's cybersecurity posture to align with SEC guidelines. This session is essential for CCOs, IT professionals, and owners of Investment Advisory Firms.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.