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

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

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 training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

This software verification and validation training will discuss how to develop / implement formal software Verification and Validation methods for devices, production and test equipment and electronic records / signatures / Part 11 to meet regulatory / cGMP expectations, reducing the risk of 483 observations and Warning Letters. US FDA, Several standards and industry recommendations will be described in this V&V methods.

This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.

This webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective risk and hazard analysis for medical devices as per FDA, FTA, FMEA, and FMECA guidelines.

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

This excel validation training / webinar will demonstrate how to design spreadsheets for Part 11/GxP /SOX/HIPAA compliance. And how to document planning, specifications, installation, testing and changes to meet FDA requirements.

This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.

This FDA compliance webinar will help the attendees develop an effective training program and training plans for an organization. Attendees will learn GxP training requirements in US and EU.

This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.

The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.

This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.

This webinar will focus on the effective crisis communication strategies. Attendees will learn best practices to protect their organization’s brand in the time of crisis.

This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.

This training program will guide attendees in implementing QbD principles from discovery through product discontinuation. It will also illustrate applying statistics to set specifications and validate measurement systems (assays) and discuss utilizing risk management tools to identify and prioritize potential critical process parameters.

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 training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.