Category:
Author:
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
30-Nov at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
How to Implement a Compliant Training Program and Reduce Human Error
01-Dec at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Ginette Collazo Ginette Collazo
$199
Detailed Investigations: How to avoid an observation
01-Dec at 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 60 Minutes
Carl Patterson Carl Patterson
$199
Best Practices To Help You Pass An FDA Computer System Validation Audit
01-Dec at 02:30 PM EST | 11:30 AM PST | 01:30 PM CT Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
Managing Your FDA Inspection’s 483 Observations
01-Dec at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
Casper (Cap) Uldriks Casper (Cap) Uldriks
$199
Developing an Effective CAPA Management and Root Cause Analysis System
02-Dec at 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 180 Minutes
Danielle DeLucy Danielle DeLucy
$499
Secrets for Writing Excellent SOPs for Medical Device QMS
02-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 90 Minutes
Susanne Manz Susanne Manz
$199
FDA’s Regulation Human Cellular Biologics including Preclinical and First-In-Human Considerations
02-Dec at 11:00 AM EST | 08:00 AM PST | 10:00 AM CST Duration 90 Minutes
Karl M. Nobert Karl M. Nobert
$199
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall
02-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$299
Learn the latest webinar Software Validation Utilizing Principles of Lean Documents and Lean Configuration
02-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 90 Minutes
Jose Mora Jose Mora
$199
Webinar FDA’s Regulatory Management of Your Cybersecurity Threats
03-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST 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
03-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 2hrs
John G. Lanese John G. Lanese
$499
Understanding the Design Verification and Validation Requirements for Medical Devices
04-Dec at 12:00 PM EST | 09:00 AM PST | 11:00 AM CST Duration 60 Minutes
Meena Chettiar Meena Chettiar
$199
FDA Warnings - common trends and observations and how to prepare for FDA inspection
07-Dec at 01:30 PM EST | 10:30 AM PST | 12:30 PM CST Duration 90 Minutes
Eleonora Babayants Eleonora Babayants
$199
FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You
7-8 Dec , 2020 at 10:00 AM EST to 04:00 PM EST
Karl M. Nobert Karl M. Nobert
$1,699
A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls
08-09 Dec at 10:00 AM EST to 04:00 PM EST
Rita Hoffman Rita Hoffman
$1,699
Rouge Monitoring - The usage of science-based online instrumentation to determine derouging and pas
08-Dec at 01:30 PM EST | 10:30 AM PST | 12:30 PM CST Duration 60 Minutes
Nissan Cohen Nissan Cohen
$199
21 CFR Part 11, SaaS/Cloud, EU GDPR - What Regulatory, Quality & Compliance Professionals Need to Know
09-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 60 Minutes
David Nettleton David Nettleton
$199
Clinical Data Management Training
December 10-11, 2020 (10:00 AM - 4:00 PM EDT)
Elaine Eisenbeisz Elaine Eisenbeisz
$1,699
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
08 - 09 Dec,2020, 26- 28 Jan,2021 and 23-25 Feb at 12:30 PM - 05:00 PM EST
Carolyn Troiano Carolyn Troiano
$1,650
FDA Compliance and Mobile Applications
14-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
Sunscreens: Their Importance and US Regulations
15-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 90 Minutes
Paolo Giacomoni Paolo Giacomoni
$199
NEW FDA Proposed FSMA Rule on Food Traceability During COVID19 – New Course
15-Dec at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 60 Minutes
Dr. John M. Ryans Dr. John M. Ryans
$199
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
26-Jan at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$229
Medical Device Cybersecurity and FDA Compliance
23-Feb at 01:00 PM EST | 10:00 AM PST | 12:00 PM CST Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$229
Understanding Quality Control Testing
MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
$199
Annex 1 and its Comparison to Critical Utilities Compendial mandates: What does it all imply to the
MP3 Download Duration 60 Minutes
Nissan Cohen Nissan Cohen
$199
Technical Writing for the Pharmaceutical Industry
MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
$199
Computer System Validation Professional Certification Program 3 Days
On Demand 3-Day Virtual Seminar
Carolyn Troiano Carolyn Troiano
$1,650
Understanding the FDA: How to avoid the most recent observations - Annual 4-Part Live Training Annual
MP3 Download Annual 4-Part
Carl Patterson Carl Patterson
$599
Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies
MP3 Download -Duration 60 Minutes
Meena Chettiar Meena Chettiar
$199
Cosmetic Ingredients: from Science to Practical Use
MP3 Download Duration 90 Minutes
Paolo Giacomoni Paolo Giacomoni
$199
How to write SOP's that Avoid Human Error
MP3 Download Duration 90 Minutes
Ginette Collazo Ginette Collazo
$199
FDA’s Ambitious Regulation of Social Media - New Course By FDA Investigator
MP3 Download Duration 60 Minutes
Casper (Cap) Uldriks Casper (Cap) Uldriks
$229
Data Integrity Practices for the Laboratory and Beyond
MP3 Download -Duration 90 Minutes
Kelly Thomas Kelly Thomas
$199
A Critical Step in Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
MP3 Download 90 Minutes
Carolyn Troiano Carolyn Troiano
$199