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

/ Nov

Tuesday-2019

How to Prepare a Standard Operating Procedure (SOP)?

Speaker: Dr. Afsaneh Motamed Khorasani
Product ID: 705131
Duration: 60 Min

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.

* Per Attendee
$229

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/ Dec

Tuesday-2019

Introduction to Root Cause Investigation for CAPA

Speaker: Vanessa Lopez
Product ID: 704409
Duration: 60 Min

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.

* Per Attendee
$229

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Recorded/CD

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

Speaker: Tanvir Mahmud
Product ID: 702422
Duration: 90 Min

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.

CD/Recorded
$299

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Recorded/CD

Human Error Reduction in GMP manufacturing

Speaker: Ginette M Collazo
Product ID: 704107
Duration: 90 Min

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.

CD/Recorded
$299

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Recorded/CD

Risk Analysis in Medical Device Design

Speaker: Charles H Paul
Product ID: 704803
Duration: 60 Min

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.

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Recorded/CD

The Most Serious FDA 483s - How to Avoid Them

Speaker: John E Lincoln
Product ID: 702766
Duration: 90 Min

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.

CD/Recorded
$299

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Recorded/CD

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Speaker: Dr. Ludwig Huber
Product ID: 701242
Duration: 75 Min

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.

CD/Recorded
$299

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Recorded/CD

ASTM 2500: Lessons Learned Through a Decade of Implementation

Speaker: Kelly Thomas
Product ID: 705911
Duration: 90 Min

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.

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Recorded/CD

Effective Training Practices for FDA Compliance

Speaker: Dr. Ludwig Huber
Product ID: 701243
Duration: 75 Min

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.

CD/Recorded
$249

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Recorded/CD

Verification vs. Validation in FDA Regulated Industries

Speaker: John Chapman
Product ID: 700828
Duration: 60 Min

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.

CD/Recorded
$249

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Recorded/CD

How to Prepare for the New EU Medical Device Regulations

Speaker: Richard Young
Product ID: 705513
Duration: 90 Min

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.

CD/Recorded
$279

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Recorded/CD

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

Speaker: Edwin Waldbusser
Product ID: 705432
Duration: 60 Min

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.

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Recorded/CD

Managing Communication in a Crisis and Protecting Your Brand

Speaker: Michael Barrio
Product ID: 705448
Duration: 60 Min

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.

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Recorded/CD

Implementing a Modern Pharmaceutical Quality System

Speaker: Steven Laurenz
Product ID: 705055
Duration: 60 Min

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

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Recorded/CD

Quality by Design

Speaker: Heath Rushing
Product ID: 705051
Duration: 60 Min

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.

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Recorded/CD

Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

Speaker: Steven Grossman
Product ID: 705023
Duration: 90 Min

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.

CD/Recorded
$199

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Recorded/CD

Project Risk Management

Speaker: Mario Mosse
Product ID: 705015
Duration: 90 Min

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.

CD/Recorded
$229

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Recorded/CD

Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget

Speaker: Christopher R DeVany
Product ID: 705013
Duration: 90 Min

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.

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Recorded/CD

Selection and Management of Contract Vendors

Speaker: Peggy Berry
Product ID: 704884
Duration: 90 Min

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.

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Recorded/CD