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Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?

Available until

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
%
COMPLETE
$389
Sunscreens: Their Importance and US Regulations

Available until

MP3 Download Duration 90 Minutes
Paolo Giacomoni Paolo Giacomoni
%
COMPLETE
$199
Overview of Pharmacovigilance Under COVID-19

Available until

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
%
COMPLETE
$199
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

Available until

MP3 Download / Online On Demand-Duration 180 Minutes
John E Lincoln John E Lincoln
%
COMPLETE
$399
Learn the latest Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar

Available until

MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$199
A Culture of Quality is a Competitive Advantage

Available until

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
%
COMPLETE
$199
Understanding the Design Verification and Validation Requirements for Medical Devices

Available until

MP3 Download Duration 60 Minutes
Meena Chettiar Meena Chettiar
%
COMPLETE
$199
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Available until

MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$199
Managing Compliance during the Pandemic

Available until

MP3 Download Duration 60 Minutes
Danielle DeLucy Danielle DeLucy
%
COMPLETE
$199
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

Available until

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
%
COMPLETE
$199
4-Hour Virtual Seminar - Batch Record Review and Product Release

Available until

MP3 Download Duration 240 Minutes
Danielle DeLucy Danielle DeLucy
%
COMPLETE
$499
NEW FDA Proposed FSMA Rule on Food Traceability During COVID19 – New Course

Available until

MP3 Download Duration 60 Minutes
Dr. John M. Ryans Dr. John M. Ryans
%
COMPLETE
$199
Properly Managing CAPA Programs for Successful Implementation

Available until

MP3 Download Duration 90 Minutes
Danielle DeLucy Danielle DeLucy
%
COMPLETE
$199
Why people make mistakes. Understanding Human error

Available until

MP3 Download Duration 90 Minutes
Ginette Collazo Ginette Collazo
%
COMPLETE
$199
Clinical Data Management Training

Available until

MP3 Download Duration 2 Day
Elaine Eisenbeisz Elaine Eisenbeisz
%
COMPLETE
$1,699
Rouge Monitoring - The usage of science-based online instrumentation to determine derouging and pas

Available until

MP3 Download Duration 60 Minutes
Nissan Cohen Nissan Cohen
%
COMPLETE
$199
Webinar FDA’s Regulatory Management of Your Cybersecurity Threats

Available until

MP3 Download -Duration 60 Minutes
Casper (Cap) Uldriks Casper (Cap) Uldriks
%
COMPLETE
$199
Masterclass: 4 Keys to Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations

Available until

MP3 Download Duration 120 Minutes
John G. Lanese John G. Lanese
%
COMPLETE
$499
FDA’s Regulation Human Cellular Biologics including Preclinical and First-In-Human Considerations

Available until

MP3 Download Duration 90 Minutes
Karl M. Nobert Karl M. Nobert
%
COMPLETE
$199
Learn the latest webinar Software Validation Utilizing Principles of Lean Documents and Lean Configuration

Available until

24-Feb,2021 at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Jose Mora Jose Mora
%
COMPLETE
$199
Cybersecurity, Data Integrity, Part 11, and Required Software Validation

Available until

MP3 Download This online training describes FDA Guidances on Cybersecurity and Data Integrity , FDA’s enforcement, Software Validation , CGMPs and Cloud
John E Lincoln John E Lincoln
%
COMPLETE
$399
Understanding the Design Verification and Validation Requirements for Medical Devices

Available until

MP3 Download Duration 60 Minutes
Meena Chettiar Meena Chettiar
%
COMPLETE
$199
Managing Your FDA Inspection’s 483 Observations

Available until

MP3 Download Duration 60 Minutes
Casper (Cap) Uldriks Casper (Cap) Uldriks
%
COMPLETE
$199
Secrets for Writing Excellent SOPs for Medical Device QMS

Available until

MP3 Download Duration 90 Minutes
Susanne Manz Susanne Manz
%
COMPLETE
$199
Patient Access of PHI and Communications – How to Use Plain Texting and E-mail under HIPAA

Available until

MP3 Download / Online On Demand-Duration 90 Minutes
Jim Sheldon-Dean Jim Sheldon-Dean
%
COMPLETE
$199
Best Practices To Help You Pass An FDA Computer System Validation Audit

Available until

MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$199
Detailed Investigations: How to avoid an observation

Available until

MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
%
COMPLETE
$199
How to Implement a Compliant Training Program and Reduce Human Error

Available until

MP3 Download Duration 90 Minutes
Ginette Collazo Ginette Collazo
%
COMPLETE
$199
What You Need to Know IEC 62304 and Demystifying Software Validation using the Principles of LDLC

Available until

MP3 Download Duration 180 Minutes
Jose Mora Jose Mora
%
COMPLETE
$299
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

Available until

MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$199
Understanding Quality Control Testing

Available until

MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
%
COMPLETE
$199
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall

Available until

MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
%
COMPLETE
$299
Annex 1 and its Comparison to Critical Utilities Compendial mandates: What does it all imply to the

Available until

MP3 Download Duration 60 Minutes
Nissan Cohen Nissan Cohen
%
COMPLETE
$199
Data Integrity Practices for the Laboratory and Beyond

Available until

MP3 Download -Duration 90 Minutes
Kelly Thomas Kelly Thomas
%
COMPLETE
$199
Technical Writing for the Pharmaceutical Industry

Available until

MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
%
COMPLETE
$199
Understanding the FDA: How to avoid the most recent observations - Annual 4-Part Live Training Annual

Available until

MP3 Download Annual 4-Part
Carl Patterson Carl Patterson
%
COMPLETE
$599
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