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Courses

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
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
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
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
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
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
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
Properly Managing CAPA Programs for Successful Implementation
MP3 Download Duration 90 Minutes
Danielle DeLucy Danielle DeLucy
$199
Clinical Data Management Training
MP3 Download Duration 2 Day
Elaine Eisenbeisz Elaine Eisenbeisz
$1,699
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
FDA’s Regulation Human Cellular Biologics including Preclinical and First-In-Human Considerations
MP3 Download Duration 90 Minutes
Karl M. Nobert Karl M. Nobert
$199
Learn the latest webinar Software Validation Utilizing Principles of Lean Documents and Lean Configuration
24-Feb,2021 at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Jose Mora Jose Mora
$199
Cybersecurity, Data Integrity, Part 11, and Required Software Validation
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
$399
Understanding the Design Verification and Validation Requirements for Medical Devices
MP3 Download Duration 60 Minutes
Meena Chettiar Meena Chettiar
$199
Best Practices To Help You Pass An FDA Computer System Validation Audit
MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
Detailed Investigations: How to avoid an observation
MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
$199
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
Understanding Quality Control Testing
MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
$199
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall
MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$299
Data Integrity Practices for the Laboratory and Beyond
MP3 Download -Duration 90 Minutes
Kelly Thomas Kelly Thomas
$199
Technical Writing for the Pharmaceutical Industry
MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
$199
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
FDA's Recent Regulation on the Use of Social Media
MP3 Download -Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
Upgrade Your Medical Device Recall Strategy
MP3 Download Duration 90 Minutes
Kelly Thomas Kelly Thomas
$199
Sterilization of Pharmaceutical Products and Medical Devices During COVID19
MP3 Download Duration 60 Minutes
Carl Patterson Carl Patterson
$199
3 Hours Virtual Seminar on Successful Deviation Investigations
MP3 Download Duration 180 Minutes
Danielle DeLucy Danielle DeLucy
$399
Medical Device Software: Verification, Validation & Compliance
MP3 Download Duration 60 Minutes
Nancy Knettell Nancy Knettell
$229
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Labo
MP3 Download Duration 60 Minutes
John C. Fetzer John C. Fetzer
$199
Trends in FDA Compliance and Enforcement for Regulated Computer Systems
MP3 Download Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$199
Current regulatory thinking on Data Integrity in 2020
MP3 Download Duration 2 Days
Carolyn Troiano Carolyn Troiano
$1,495
FDA’s Latest UDI Labeling Requirements
MP3 Download Duration 60 Minutes
John E Lincoln John E Lincoln
$199
Issues in Calibrations and Accuracy in Method Validation
MP3 Download Duration 60 Minutes
John C. Fetzer John C. Fetzer
$199

Bundles

GMP Laboratory Control Professionals Certification Program
WCS 6-part GMP Laboratory Control Certification program provides the key principles and tools required to become a GMP Laboratory Control Professional.
Courses: 6
$1,295
Sterilization Professionals Certification Program
WCS 5-Part Sterilization Professional Certification program provides detailed training on the key principals and tools required to become a Sterilization Professional
Courses: 5
$1,495
Pharmacovigilance Certification
Pharmacovigilance Online Courses & Certifications
Courses: 2
$3,995
Good Manufacturing Practices (GMP) Certification Course
Online GMP Training courses
Courses: 4
$1,495
FDA Inspection Readiness Certification Program
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations.
Courses: 7
$1,495
US Dietary Supplements Certification
US Dietary Supplements Virtual Course Online
Courses: 3
$3,995
Lyophilization Basics for Pharmaceuticals
8 hrs Instructor-led Virtual Seminar -Lyophilization Pharmaceutical Course
Courses: 1
$1,295