Below is the schedule for our live webinars that are coming soon, and we have a countdown clock for our next live-streaming YouTube video.
- SYS-019 Post-Market Surveillance Procedure Webinar (October 21, 2024 @ 10:30 a.m. ET)
- Cybersecurity Work Instruction (October 24, 2024 @ 10:30 a.m. ET)
- SYS-022 Statistical Techniques Procedure (October 28, 2024 @ 10:30 a.m. ET)
- FDA PreSTAR Tutorial Kick-off (October 31, 2024 @ 10:30 a.m. ET)
- SYS-023 Nonconforming Product Procedure Webinar (November 4, 2024 @ 10:30 a.m. ET)
- FDA PreSTAR Tutorial Part 2 of 4 (November 7, 2024 @ 10:30 a.m. ET)
- SYS-027 Purchasing Procedure Webinar (November 11, 2024 @ 10:30 a.m. ET)
- FDA PreSTAR Tutorial Part 3 of 4 (November 14, 2024 @ 10:30 a.m. ET)
- SYS-032 Identification and Traceability Procedure Webinar (November 18, 2024 @ 10:30 a.m. ET)
- FDA PreSTAR Tutorial Finale (November 21, 2024 @ 10:30 a.m. ET)
- SYS-030 Labeling Procedure Webinar (November 25, 2024 @ 10:30 a.m. ET)
- Regulatory Submission Plan Webinar (December 5, 2024 @ 10:30 a.m. ET
Do you have suggestions for future webinars? Visit our Suggestion Portal.
Our latest YouTube shorts.
Weekly Live-Streaming Topics on YouTube
Below is a countdown clock for our next live-stream YouTube video and the schedule for the new live webinars we are hosting. Our next YouTube Live-streaming video will be on Friday @ 12:30 pm ET (October 25, 2024). The next live-streaming YouTube video will discuss “Why do we need FDA pre-submissions?”
Human Factors Webinars
- Formative Usability Testing Webinar & Template Bundle – $79
- Use Error and Abnormal Use Decision Tree Training – $79
- Use Specification Template & Webinar Bundle – $79
- Known Use Errors Search Webinar – $129
- Task Analysis Template & Webinar Bundle – $129 – Live Webinar, October 17, 2024
- Use-Related Risk Analysis (URRA) Template & Webinar Bundle – $299
- Participant Screening & Data Collection Forms – $79 – November 27, 2024
- Summative Usability Testing Protocol & Webinar Bundle – $199 – Live Webinar, December 19, 2024
- Summative Usability Testing Report – Live-streaming Free Webinar, December 20, 2024
Risk Management
- Auditing Risk Management Files – $64.50
- Risk Management Training Webinar for ISO 14971:2019 – $129
- ISO/TR 24971:2020 Guidance on the application of risk management – $129
- Benefit-Risk Analysis Webinar – $79
- Hazard identification webinar – $79 (live on August 29, 2024)
Design Controls
- Design Controls Webinar (Updated for 2024) – $129
- Design Change Webinar (Updated for 2022) – $129
- Design History File (DHF) Webinar (Updated for 2024) – $129 (September 26, 2024 @ 10:30 a.m. ET)
- Combining Product Risk Management with Design Controls – $129
Quality System Webinars
- ISO 13485 – need training? – Stage 1 & 2 training webinars – for $258
- 21 CFR 820 Training Webinar (new QMSR) – $79
- How to Create a Risk-Based CAPA Process – $129
- How to qualify your suppliers – $129
- Good Documentation Practices “GDP 101” – $129
- Complaint Handling and Vigilance Reporting – $129
Auditing
- Auditing MDSAP and QSR 4-part Webinar Series – $299
- Remote & Supplier Auditing – $129
- Tool kit for supplier auditing – Forms, templates, etc. – $299
- How to audit using the process approach – $129
MISC Webinars
- How to write Instructions for Use (IFU) Webinar – $129
- Post-Market Surveillance Summary Report Webinar – $129
- IFU Validation and PMS Webinar – $49
- Process Validation: Avoiding Nonconformities, Complaints, FDA 483s and Recalls – $129
- Bioburden Failure Analysis: How auditors can investigate spikes in environmental monitoring – $129
- 7 Steps to Respond to an FDA 483 Inspection Observation – $129
- FDA Medical Device Recalls, Labeling, and 21 CFR 820.120 – $129
- 513g Request Webinar – $149
CE Marking Webinars
- EU MDR Regulation Webinar Series (8-part series) – $825
- CE Marking to UK Market Webinar – for $129
- Technical File Auditing for Compliance with MDR – $129
- FDA Declaration of Conformity (Form 3654) Webinar – $49
- New European Medical Device Regulations Webinar – $129
- Notified Body Unannounced Audit: A Roadmap for Successful Preparation – $64.50
- Preparing for the New Post Market Clinical Follow Up (PMCF) Requirements – updated for Regulation (EU) 2017/745 – $129
- Preparing for New Technical File and Design Dossier Requirements: How to Convert a Class IIb Technical File to a Class III Design Dossier – $129
Canadian Medical Device Licensing
- Canadian Device Licensing Webinar – $49
- Health Canada Medical Device Regulations & CMDCAS Requirements – $129
If you want to be notified of new webinars another way, including the paid webinars that we do not post on our YouTube channel, please subscribe to our email webinar notification list using the form below:
In addition to the webinars available for purchase on this page, you can also watch videos that we have posted on our YouTube channel. If you are a channel subscriber, you will receive automatic notifications of new YouTube postings on our channel by clicking on the notification bell. The time remaining until our YouTube live-streaming video is shown below, and please don’t forget to email Rob your questions at rob@13485cert.com.
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 Portal.
Don’t forget to subscribe to our YouTube Channel
- What is a CE Mark and how to you apply for certification? – Free
- Cybersecurity Webinar – Free
- Interview with Aaron Moncur – Test Fixture Design – Free
- Interview with Rick Stockton: How to Manage Your a Design FMEA – Free
- Management Review Webinar: Making Your Meetings More Effective – Free
- Create an ISO 13485 Quality Plan – Free
- Audit team communication during a remote audit – Free
- Opening Meetings Webinar – Free if you submit a question
- Is Your Medical Device Startup Missing Out on the R&D Tax Credit? – Free
- Post-Market Clinical Follow-up (PMCF) Mobile App – Free if you submit a question
- Human Factors Testing Webinar – Free if you submit a question
- Traceability Matrix Webinar – Free if you submit a question
- IEC 60601 Standards Status Update Webinar – Free if you submit a question
- Combining Risk and Design Controls – Free if you submit a question
- Factory-CRO Clinical Study Webinar – Free if you submit a question
- How To Perform A CAPA Effectiveness Check and 5 Tools for Root Cause Analysis – Free Download
- 6 Steps to ISO 13485 Certification – Free Download
- Management Review Webinar: Making Your Meetings More Effective – Free Download
- FDA UDI Regulation’s Impact on Medical Device Labelers – Free Download
- MDSAP QMS update webinar to meet country-specific requirements – Free Download