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Home › Online Training ›  Medical device Training

Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

Sub Categories: Risk Management | GXP Medical Devices | Marketing and Promotion | Testing and Validation | Audits & Inspections | IVD | Sterilization | Crisis Management | QMS, ISO 13485, CAPA | Supply Chain and Manufacturing | R & D | Regulations & Guidances | Documentation and Data Management
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Medical Device Recalls - a Prevention Strategy
29
/ Sep
Tuesday-2020

Medical Device Recalls - a Prevention Strategy

  • Speaker: Charles H Paul
  • Product ID: 706537
  • Duration: 60 Min
The rough breakdown of medical device failures is 60% residing with the product specification and only 30% of the errors in the components themselves. This rough breakdown indicates that most of the problems are referred to as management errors – caused by faulty systems, processes, and conditions. A failure of procedures and execution. In other words, management failure. In this webinar, learn the strategies to prevent such medical device recalls.
* Per Attendee
$329
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How to Investigate Environmental Monitoring Excursions
30
/ Sep
Wednesday-2020

How to Investigate Environmental Monitoring Excursions

  • Speaker: Gerry O Dell
  • Product ID: 701354
  • Duration: 90 Min
This environmental excursion investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.
* Per Attendee
$199
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Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP
30
/ Sep
Wednesday-2020

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

  • Speaker: John E Lincoln
  • Product ID: 700817
  • Duration: 60 Min
This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.
* Per Attendee
$329
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FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat
6
/ Oct
Tuesday-2020

FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat

  • Speaker: John Misock
  • Product ID: 706557
  • Duration: 120 Min
FDA regulated industries can prophet by understanding the regulatory power of FDA and incorporating this knowledge into their daily routine. Time and resources spent preparing for the inevitable inspection will pay back proportionately. By doing your homework and putting simple principles to work you can minimize the negative effects of FDA’s power and put everyone in your organization at ease. By understanding the risks inherent in your products, you can develop a quality system that will align your operation with FDA’s expectations. Why live in fear when you can rest at night knowing you are ready?
* Per Attendee
$399
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Streamlining your QMS and Audit System for Remote Audits
7
/ Oct
Wednesday-2020

Streamlining your QMS and Audit System for Remote Audits

  • Speaker: Betty Lane
  • Product ID: 703448
  • Duration: 60 Min
This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
* Per Attendee
$199
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Implementation and Management of GMP Data Integrity
7
/ Oct
Wednesday-2020

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
* Per Attendee
$249
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Medical Device Cybersecurity Risk Management Training
16
/ Oct
Friday-2020

Medical Device Cybersecurity Risk Management Training

  • Speaker: Frank Stein
  • Product ID: 706560
  • Duration: 3 hrs
This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
* Per Attendee
$329
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FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
28
/ Oct
Wednesday-2020

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
* Per Attendee
$229
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Supplier Management with the new Medical Device Regulation EU MDR 745/2017
9
/ Nov
Monday-2020

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

  • Speaker: Frank Stein
  • Product ID: 706068
  • Duration: 90 Min
In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.
* Per Attendee
$249
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Attaining Your CE Mark for Your Medical Device in the EU
18
/ Nov
Wednesday-2020

Attaining Your CE Mark for Your Medical Device in the EU

  • Speaker: Charles H Paul
  • Product ID: 706543
  • Duration: 60 Min
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). By placing the CE mark on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements necessary to achieve CE marking status. With that mark, the manufacturer is ensuring validity for that product to be sold throughout the EEA. CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there.
* Per Attendee
$329
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ISO 14971 Medical Device Risk Management Training
19
/ Nov
Thursday-2020

ISO 14971 Medical Device Risk Management Training

  • Speaker: Frank Stein
  • Product ID: 706564
  • Duration: 3 hrs
This course will give an introduction into the new ISO 14971:2019 and how to create a risk management file according the ISO 14971:2019. It will give you an overview about the requirements the interfaces to Post-Market-Surveillance, Clinical Evaluation, Bench-Testing and Life-Cycle-Management. and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.
* Per Attendee
$429
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Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
23
/ Nov
Monday-2020

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

  • Speaker: Frank Stein
  • Product ID: 706565
  • Duration: 4 Hrs
This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
* Per Attendee
$429
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Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
CD/Recorded
$299
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Recorded/CD
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
CD/Recorded
$299
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Recorded/CD
ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

  • Speaker: Betty Lane
  • Product ID: 702871
  • Duration: 60 Min
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2019 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
CD/Recorded
$399
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Recorded/CD
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

  • Speaker: Joy McElroy
  • Product ID: 704531
  • Duration: 120 Min
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
CD/Recorded
$349
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Recorded/CD
Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

  • Speaker: Frank Stein
  • Product ID: 706165
  • Duration: 90 Min
Attend this webinar to understand the changes of the new EU MDR 2017/745 regarding quality management, the EN ISO 13485:2016 and the EU MDR 2017, and how to implement the changes to fast track internal audit.

You might also wish to attend our comprehensive 2-day virtual seminar on Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

CD/Recorded
$299
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Recorded/CD
Supplier and Service Provider Controls: FDA Expectations

Supplier and Service Provider Controls: FDA Expectations

  • Speaker: Vanessa Lopez
  • Product ID: 704844
  • Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
CD/Recorded
$349
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Recorded/CD
Spotlight on Complaint Handling and Medical Device Reporting

Spotlight on Complaint Handling and Medical Device Reporting

  • Speaker: Susanne Manz
  • Product ID: 706099
  • Duration: 90 Min
This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.
CD/Recorded
$299
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Recorded/CD
QA Agreements for ISO 13485:2019 and other Regulatory Compliance

QA Agreements for ISO 13485:2019 and other Regulatory Compliance

  • Speaker: Betty Lane
  • Product ID: 703515
  • Duration: 60 Min
In this webinar you will learn how to create detailed quality agreements (QA Agreements) for key suppliers, particularly those for outsourced processes, and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485:2016 and MDSAP. The agreements discussed will meet the expectations of the GHTF and NBOG supplier guidance documents which are now an expectation of both the FDA and most ISO 13485 auditors. These supplier QA agreements can be an important part of demonstrating that you have control of your key suppliers.
CD/Recorded
$249
View Details
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