Training Webinars Available On-Demand

New: De Novo Application Webinar, Updated for FY 2019 – $49

Date: Friday, January 4, 2019

Time: 12:00pm EST (Noon)

New: EU Regulation Webinar Series (8-part series) – $825

Starting Date: Thursday, January 24, 2019

Time: 12:00pm EST (Noon), Weekly

The following is a list of quality and regulatory training webinars that are available for on-demand purchase from this website. If you subscribe to our email notification list using the form on the right, we will notify you by email of any new webinars when we add them to this page. You can also suggest new topics by submitting your idea to the Suggestion Box:

• De Novo Application Webinar, Updated for FY 2019 – $49
• Design Controls Training Webinar – $129
• ISO 14971 Risk Management Webinar- updated for ISO/DIS 14971:2018 & Regulation (EU) 2017/745 – $129
• Small Business Qualification Webinar – $19
• Canadian Device Licensing Webinar – $49
• IFU Validation and PMS Webinar – $49
• In Vitro Diagnostics (IVD) 510k Webinar – $29
• Clinical Evaluation Report Procedure & Webinar Bundle – $299
• Vol 15 – Biocompatibility – $79
• Vol 5 – 510(k) Summary – $79
• Vol 19 & 20 – Animal & Clinical Studies – $79
• Vol 10 – Executive Summary & RTA Checklist – $79
• Performance Testing Webinar – $49
• Redacted FOIA 510k Webinar – $79
• FDA Declaration of Conformity (Form 3654) Webinar – $49
• Sterilization Shelf Life Webinar – $49
• How to Complete a 510k Cover Letter Webinar – $29
• Labeling & UDI 510k Requirements Webinar – $49
• Device Description Webinar – $29
• 510k Hardware & Software Documentation Webinar –  $129
• 510k Project Management Lessons Learned Webinar –  $129
• New European Medical Device Regulations Webinar –  $129
• Medical Device Reporting Webinar Bundle – 2 Live Recordings & Procedure for $299
• Control of Nonconforming Product Webinar Bundle – 2 Live Recordings & Procedure for $299
• Design Change Webinar – $129
• Design History File (DHF) Webinar –  $129
• ISO 13485:2016 Updates – Stage 1 & Stage 2 – 4 Webinar Bundle for $258
• Death of design fmea –  $129
• Creating a Risk-Based CAPA Process  – $129
• How to Combine a 510k Submission with CE Marking and Reduce Your Workload by 35% –  $129
• FDA Pre-Sub Meetings –  $129
• 510k Submissions: Predicate Device Selection – $129
• 510k Submissions: Substantial Equivalence – $129
• Combining Product Risk Management with Design Controls – $129
• Process Validation: Avoiding Nonconformities, Complaints, FDA 483s and Recalls – $129
• Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring – $129
• 510k Submission Section 4: Indications for Use – $129
• 510k Project Management Webinar – $129
• Remote Auditing of Suppliers: Tips to Save You Time and Money – $129
• Notified Body Unannounced Audit: A Roadmap for Successful Preparation  – $129
• Obtaining the CE Mark: Compliance with the Medical Device Directive (MDD) – $129
• Preparing for the New Post Market Clinical Follow Up (PMCF) Requirements – updated for Regulation (EU) 2017/745 – $129
• Good Documentation Practices “GDP 101”  – $129
• CAPA & Complaint Handling: Hot FDA Inspection Topics Webinar (Q & A With Ex FDA)  – $129
• 7 Steps to Respond to an FDA 483 Inspection Observation – $129
• FDA Medical Device Recalls, Labeling, and 21 CFR 820.120  – $129
• Complaint Handling and Vigilance Reporting – $129
• Adding Value with Audits Using the Process Approach (A.K.A Turtle diagrams)  – for $129
• 21 CFR 820 – A Roadmap to Compliance – for $129
• How to Improve Your CAPA Process – for $129
• Preparing for New Technical File and Design Dossier Requirements: How to Convert a Class IIb Technical File to a Class III Design Dossier – for $129
• Are your Suppliers Qualified? Prove It!  – $129
• Health Canada Medical Device Regulations & CMDCAS Requirements   – $129