WEBINARS

 

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

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

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.

Recording Available

* Per Attendee $299

 

Human Error Reduction in GMP Manufacturing

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704107

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.

Recording Available

* Per Attendee $299

 

Introduction to Root Cause Investigation for CAPA

webinar-speaker   Vanessa Lopez

webinar-time   60 Min

Product Id: 704409

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.

Recording Available

* Per Attendee $299

 

Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701461

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.

Recording Available

* Per Attendee $399

 

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

webinar-speaker   Tanvir Mahmud

webinar-time   90 Min

Product Id: 702422

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.

Recording Available

* Per Attendee $299

 

Risk Analysis in Medical Device Design

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 704803

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.

Recording Available

 

The Most Serious FDA 483s - How to Avoid Them

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702766

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.

Recording Available

* Per Attendee $299

 

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 701242

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.

Recording Available

* Per Attendee $299

 

ASTM 2500: Lessons Learned Through a Decade of Implementation

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 705911

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.

Recording Available

 

Effective Training Practices for FDA Compliance

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 701243

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.

Recording Available

* Per Attendee $249

 

Verification vs. Validation in FDA Regulated Industries

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700828

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.

Recording Available

* Per Attendee $249

 

How to Prepare for the New EU Medical Device Regulations

webinar-speaker   Richard Young

webinar-time   90 Min

Product Id: 705513

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.

Recording Available

* Per Attendee $279

 

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

webinar-speaker   Edwin Waldbusser

webinar-time   60 Min

Product Id: 705432

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.

Recording Available

 

Managing Communication in a Crisis and Protecting Your Brand

webinar-speaker   Michael Barrio

webinar-time   60 Min

Product Id: 705448

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.

Recording Available

 

Implementing a Modern Pharmaceutical Quality System

webinar-speaker   Steven Laurenz

webinar-time   60 Min

Product Id: 705055

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

Recording Available

 

Quality by Design

webinar-speaker   Heath Rushing

webinar-time   60 Min

Product Id: 705051

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.

Recording Available

 

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

webinar-speaker   Steven Grossman

webinar-time   90 Min

Product Id: 705023

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.

Recording Available

* Per Attendee $199

 

Project Risk Management

webinar-speaker   Mario Mosse

webinar-time   90 Min

Product Id: 705015

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Christopher R DeVany

webinar-time   90 Min

Product Id: 705013

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.

Recording Available

 

Selection and Management of Contract Vendors

webinar-speaker   Peggy Berry

webinar-time   90 Min

Product Id: 704884

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.

Recording Available

 

 

 

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