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FDA’s Plan for Modernizing the 510(k) Pathway
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
$179
Fundamentals of Good Manufacturing Practices – Developing a Compliance Mindset
MP3 Download This webinar will discuss the basic principles and requirements for Good Manufacturing Practices
David W. Husman David W. Husman
$199
Is My Data Abnormal? Normality Tests and Transformations Live Webinar
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
$299
Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course
MP3 Download This training course will provide a practical understanding of the requirement for a data governance framework
Carolyn Troiano Carolyn Troiano
$695
Webinar Analytical Method Validation and Transfer According to the New FDA Guidance
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
$499
QA and Risk Management approaches when Managing Clinical Trial Data – New Course !
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
$229
Post-Market Activities in the EU-MDR — A Detailed Analysis
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
$399
Non-conforming Materials in a Medical Device Company – dealing with in-house to field issues
MP3 Download Join industry expert Susanne Manz to learn online the essentials of dealing with non-conforming material and performing effective failure
Susanne Manz Susanne Manz
$399
Are you ready for your next regulatory inspection? On site or virtual in 2021
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
$399
Supplier Management: How to meet FDA QSR and ISO 13485 requirements in a cost effective manner
MP3 Download Duration 60 Minutes
Jeff Kasoff Jeff Kasoff
$179
Cosmetic Ingredients: from Science to Practical Use
MP3 Download Duration 90 Minutes
Paolo Giacomoni Paolo Giacomoni
$199
Creating and Maintaining an Effective and Efficient Technical Training Program
MP3 Download Duration 180 Minutes
Ginette Collazo Ginette Collazo
$299
Developing an Effective CAPA Management and Root Cause Analysis System
MP3 Download Duration 180 Minutes
Danielle DeLucy Danielle DeLucy
$499
The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process
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
$199
Continuing to Audit during a Global Pandemic – How to Optimize Effectiveness and Minimize Risk
MP3 Download Duration 60 Minutes
Susanne Manz Susanne Manz
$249
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
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
$299
Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?
MP3 Download This webinar will help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas
Susanne Manz Susanne Manz
$389
Sunscreens: Their Importance and US Regulations
MP3 Download Duration 90 Minutes
Paolo Giacomoni Paolo Giacomoni
$199
Overview of Pharmacovigilance Under COVID-19
MP3 Download This Pharmaceutical training online aims to demonstrate what the new guidances allow in terms of pharmacovigilance activities that can be relaxed
Graeme Ladds Graeme Ladds
$199
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
MP3 Download / Online On Demand-Duration 180 Minutes
John E Lincoln John E Lincoln
$399
Learn the latest Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar
MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
A Culture of Quality is a Competitive Advantage
MP3 Download This webinar will cover FDA and NB expectations for Quality Systems , Best Practices and How culture can impact quality and compliance risk in 2021
Susanne Manz Susanne Manz
$199
Understanding the Design Verification and Validation Requirements for Medical Devices
MP3 Download Duration 60 Minutes
Meena Chettiar Meena Chettiar
$199
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
Managing Compliance during the Pandemic
MP3 Download Duration 60 Minutes
Danielle DeLucy Danielle DeLucy
$199
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
MP3 Download This webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records
Carolyn Troiano Carolyn Troiano
$199
4-Hour Virtual Seminar - Batch Record Review and Product Release
MP3 Download Duration 240 Minutes
Danielle DeLucy Danielle DeLucy
$499
NEW FDA Proposed FSMA Rule on Food Traceability During COVID19 – New Course
MP3 Download Duration 60 Minutes
Dr. John M. Ryans Dr. John M. Ryans
$199
Properly Managing CAPA Programs for Successful Implementation
MP3 Download Duration 90 Minutes
Danielle DeLucy Danielle DeLucy
$199
Why people make mistakes. Understanding Human error
MP3 Download Duration 90 Minutes
Ginette Collazo Ginette Collazo
$199
Clinical Data Management Training
MP3 Download Duration 2 Day
Elaine Eisenbeisz Elaine Eisenbeisz
$1,699
Quality Control Laboratory Compliance - cGMPs and GLPs
MP3 Download Duration 2 Day
Kelly Thomas Kelly Thomas
$1,895
Rouge Monitoring - The usage of science-based online instrumentation to determine derouging and pas
MP3 Download Duration 60 Minutes
Nissan Cohen Nissan Cohen
$199
FDA Warnings - common trends and observations and how to prepare for FDA inspection
MP3 Download Duration 90 Minutes
Eleonora Babayants Eleonora Babayants
$199
Webinar FDA’s Regulatory Management of Your Cybersecurity Threats
MP3 Download -Duration 60 Minutes
Casper (Cap) Uldriks Casper (Cap) Uldriks
$199
Masterclass: 4 Keys to Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations
MP3 Download Duration 120 Minutes
John G. Lanese John G. Lanese
$499