Risk Management Training

This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.

This New Dietary supplements webinar will highlight from a quality perspective the introductory requirements of these new CGMP regulations and examine methods and strategies for meeting these new requirements.

This Risk Management webinar/training will describe enhancements to these techniques that can improve your relationships with customers and regulatory agencies, resulting in a reduced number of surprises during inspections.

This healthcare webinar will give an introduction to lean in healthcare which includes an illustrative exercise to aid participants in understanding the basic underlying concept of lean.

This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.

This Validation training will provide valuable assistance to all regulated companies that need to validate their systems. Project management is the application of knowledge, skills, tools, and techniques to manage project activities to meet project requirements

In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.

In this Medical device training understand the expectations of FDA and the EU in applying risk analysis to medical devices. Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices".

This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.

This Radiation Sterilization training will review all the changes included in the new standard and how they will affect the device manufacturer.

The purpose of this ERM (Enterprise Risk Management) training is to provide a framework of features, benefits, underlying processes, and best practices required to select or build an effective and efficient risk and compliance management system.

This Risk Analysis training guide you through the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs and step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application. Did you know that you can use your existing Risk Analyses to help you do more than manage risk? Risk Analyses can be used to prioritize and streamline Design Input, Design Output, Design V&V, and both Pre-Production.

ISO 27001, ISO 27002, NIST SP800-53 rev.4 Information System Management System (ISMS) are systematic approaches to managing sensitive company information so that it remains secure. It includes people, processes and IT systems by applying a risk management process. In this webinar, You will receive valuable information that you can implement. This is a must in the new world that is facing new Information/Cyber risks every year.

Developing an efficient Incident Response Program that allows an organization to respond with speed and agility is crucial to empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation. Information Security, Governance & Risk, are all critical aspects of planning and execution of the Information Security Plan.

In this Risk Management webinar attendees will learn the resilience strategies, recovery objectives, cyber/information security, business continuity and crisis management plans and including obtaining management support and organizing and managing the formulation of the function or process either in collaboration with, or as a key component of, an integrated risk management initiative.

This webinar is designed for managers and project leaders who have been tasked with implementing a computer security incident response team (CSIRT). Attendees will learn how to develop a CSIRT Policies, Program, Plan, Playbook, Training and Exercises in their organization.

This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.

This training program will provide an overview on how to create a business continuity audit plan that is effective and in line with the company's objectives. It will help attendees understand regulations, standards and requirements pertinent to business continuity audits as well. The webinar will define the risks or threats to the success of an audit plan and train attendees on how to test the controls in place to determine whether or not those risks are acceptable.

This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.