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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
Managing Your FDA Inspection’s 483 Observations
MP3 Download Duration 60 Minutes
Casper (Cap) Uldriks Casper (Cap) Uldriks
$199
Secrets for Writing Excellent SOPs for Medical Device QMS
MP3 Download Duration 90 Minutes
Susanne Manz Susanne Manz
$199
Patient Access of PHI and Communications – How to Use Plain Texting and E-mail under HIPAA
MP3 Download / Online On Demand-Duration 90 Minutes
Jim Sheldon-Dean Jim Sheldon-Dean
$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
How to Implement a Compliant Training Program and Reduce Human Error
MP3 Download Duration 90 Minutes
Ginette Collazo Ginette Collazo
$199
What You Need to Know IEC 62304 and Demystifying Software Validation using the Principles of LDLC
MP3 Download Duration 180 Minutes
Jose Mora Jose Mora
$299
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
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
Data Integrity Practices for the Laboratory and Beyond
MP3 Download -Duration 90 Minutes
Kelly Thomas Kelly Thomas
$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 in 2020
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
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training
MP3 Download Duration 120 Minutes
John G. Lanese John G. Lanese
$299
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
Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
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
Project Management for FDA-Regulated Companies
MP3 Download Duration 60 Minutes
John E Lincoln John E Lincoln
$199
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
CAPA: Definition, Plan and Program
MP3 Download Duration 90 Minutes
Danielle DeLucy Danielle DeLucy
$199
Understanding the Process Validation Life Cycle
MP3 Download Duration 90 Minutes
Danielle DeLucy Danielle DeLucy
$199
Risk-based Design Control - The New Paradigm for Medical Device Design
MP3 Download- Duration 60 Minutes
Jose Mora Jose Mora
$199
What should you know about the Clinical Trial Master File Compliance : A REFRESHER
MP3 Download - Duration 90 Minutes
Carolyn Troiano Carolyn Troiano
$179
Meeting Global Unique Device Identification Requirements
MP3 Download Duration 90 Minutes
Kelly Thomas Kelly Thomas
$199