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The FDA Inspection: Best Practices for Preparation, Behavior, and Response

Available until

MP3 Download This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA
Jeff Kasoff Jeff Kasoff
%
COMPLETE
$179
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Available until

MP3 Download This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program
Frank Stein Frank Stein
%
COMPLETE
$429
Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs

Available until

MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$392
Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

Available until

MP3 Download This webinar will conforms to the new ISO 62366 standard and the new FDA Guidance document.
Edwin Waldbusser Edwin Waldbusser
%
COMPLETE
$265
Building a Compliant Laboratory – From Foundation to Business Excellence

Available until

MP3 Download In this webinar speaker will define compliance, provide a translation of regulations and guidance into user requirements .
David W. Husman David W. Husman
%
COMPLETE
$199
Power Analysis for Sample Size Calculations

Available until

MP3 Download In this webinar speaker will explain how to put the power analysis techniques to use will help to assure that you’ll collect a large enough sample
Elaine Eisenbeisz Elaine Eisenbeisz
%
COMPLETE
$249
Management Review to ensure a Suitable and Effective Quality Management System

Available until

MP3 Download this course, we’ll discuss how to improve awareness, focus, and a culture of quality
Susanne Manz Susanne Manz
%
COMPLETE
$199
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Available until

MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend
Kelly Thomas Kelly Thomas
%
COMPLETE
€1.295
Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience

Available until

MP3 Download This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs)
Edwin Waldbusser Edwin Waldbusser
%
COMPLETE
$229
Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

Available until

MP3 Download This session will benefit all functional groups who have data protection responsibility, marketing responsibilities, or need to understand
William Mack Copeland William Mack Copeland
%
COMPLETE
$299
Establishing a Robust Data Integrity Program

Available until

MP3 Download This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems.
Kelly Thomas Kelly Thomas
%
COMPLETE
$199
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Available until

MP3 Download This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs)
Kelly Thomas Kelly Thomas
%
COMPLETE
$199
Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Available until

MP3 Download This training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$179
Identifying Sources of Process Unreliability Within Your Organization: You May be Surprised.

Available until

MP3 Download In this Webinar you will learn how to use Reality-Charting, The Model for Improvement, and Process Reliability Modeling
David W. Husman David W. Husman
%
COMPLETE
$209
FDA CDS Software Regulation:The Latest Guidance on Clinical Decision Support Software

Available until

MP3 Download This Webinar will discuss clinical decision support (CDS) software might be regulated as a medical device.
John E Lincoln John E Lincoln
%
COMPLETE
$199
Best Practices for Deviation Training

Available until

MP3 Download -Duration 180 Minutes
Danielle DeLucy Danielle DeLucy
%
COMPLETE
$399
Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries

Available until

MP3 Download New Root Cause Analysis Techniques and CAPA Management live webinar is for those in Operations, Facilities , Engineering and QA/QC
Meena Chettiar Meena Chettiar
%
COMPLETE
$179
Managing Risk Within Your Supplier Management Program Live Webinar

Available until

MP3 Download In this webinar, we will unpack the latest FDA requirements for supplier quality assurance (SQA)
Tim Fischer Tim Fischer
%
COMPLETE
$299
Compliant Management Controls Under 21 CFR 820 and ISO 13485

Available until

MP3 Download Best QSR and ISO 13485 requirements webinar for management controls, Organizational structure and Establishment of an internal audit program.
Jeff Kasoff Jeff Kasoff
%
COMPLETE
$179
Vaccine Patents in the Current Pandemic Climate Live Webinar

Available until

MP3 Download This presentation will discuss not only the global patenting issues facing vaccines but will also look at some of the challenges facing vaccine
Joanna Brougher Joanna Brougher
%
COMPLETE
$199
Fired by Facebook - HIPAA and social media violations of HIPAA’s privacy requirements

Available until

MP3 Download Duration 60 Minutes
Mark Brengelman Mark Brengelman
%
COMPLETE
$399
FDA’s Plan for Modernizing the 510(k) Pathway

Available until

MP3 Download This FDA Training online will explain Basic of US FDA’s Expectations for the 510(k), The Medical Device Safety Action Plan and 510(k)
John E Lincoln John E Lincoln
%
COMPLETE
$179
Fundamentals of Good Manufacturing Practices – Developing a Compliance Mindset

Available until

MP3 Download This webinar will discuss the basic principles and requirements for Good Manufacturing Practices
David W. Husman David W. Husman
%
COMPLETE
$199
Is My Data Abnormal? Normality Tests and Transformations Live Webinar

Available until

MP3 Download In this webinar, you will also learn tools and concepts to understand what makes a distribution normal and when a transformation of data
Elaine Eisenbeisz Elaine Eisenbeisz
%
COMPLETE
$299
Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course

Available until

MP3 Download This training course will provide a practical understanding of the requirement for a data governance framework
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$695
Webinar Analytical Method Validation and Transfer According to the New FDA Guidance

Available until

MP3 Download This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA
Kelly Thomas Kelly Thomas
%
COMPLETE
$499
QA and Risk Management approaches when Managing Clinical Trial Data – New Course !

Available until

MP3 Download This presentation focuses on the role of QA in the Risk Management process when deciding on how data should be collected
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$229
Post-Market Activities in the EU-MDR — A Detailed Analysis

Available until

MP3 Download Medical device training will review the new EU-MDR requirements governing Post Market Activities and discuss quality system approaches
Kelly Thomas Kelly Thomas
%
COMPLETE
$399
Are you ready for your next regulatory inspection? On site or virtual in 2021

Available until

MP3 Download This webinar is a practical, hands-on course designed to provide FDA industry with information and tools required to prepare for and manage an FDA
Alan Golden Alan Golden
%
COMPLETE
$399
Supplier Management: How to meet FDA QSR and ISO 13485 requirements in a cost effective manner

Available until

MP3 Download Duration 60 Minutes
Jeff Kasoff Jeff Kasoff
%
COMPLETE
$179
Cosmetic Ingredients: from Science to Practical Use

Available until

MP3 Download Duration 90 Minutes
Paolo Giacomoni Paolo Giacomoni
%
COMPLETE
$199
Creating and Maintaining an Effective and Efficient Technical Training Program

Available until

MP3 Download Duration 180 Minutes
Ginette Collazo Ginette Collazo
%
COMPLETE
$299
Developing an Effective CAPA Management and Root Cause Analysis System

Available until

MP3 Download Duration 180 Minutes
Danielle DeLucy Danielle DeLucy
%
COMPLETE
$499
The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process

Available until

MP3 Download This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity
William Mack Copeland William Mack Copeland
%
COMPLETE
$199
Continuing to Audit during a Global Pandemic – How to Optimize Effectiveness and Minimize Risk

Available until

MP3 Download Duration 60 Minutes
Susanne Manz Susanne Manz
%
COMPLETE
$249
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Available until

MP3 Download This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing
Roger Cowan Roger Cowan
%
COMPLETE
$299
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