ComplianceOnline

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

Human Factors Engineering in New Product Development
15
/ Jan
Tuesday-2019

Human Factors Engineering in New Product Development

  • Speaker: Tom Kramer
  • Product ID: 705153
  • Duration: 120 Min
This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.
* Per Attendee
$199
Complaint Handling, MDR's & Recalls
7
/ Feb
Thursday-2019

Complaint Handling, MDR's & Recalls

  • Speaker: John Chapman
  • Product ID: 700830
  • Duration: 60 Min
This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
* Per Attendee
$199
Recorded/CD
Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge

Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge

  • Speaker: Jeff Kasoff
  • Product ID: 701788
  • Duration: 60 Min
This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.
CD/Recorded
$249
Recorded/CD
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

  • Speaker: Jeff Kasoff
  • Product ID: 700322
  • Duration: 60 Min
This webinar will provide valuable assistance to all regulated companies; a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
CD/Recorded
$25
Recorded/CD
Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

  • Speaker: Daniel O Leary
  • Product ID: 703752
  • Duration: 90 Min
Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.
Recorded/CD
Creating a Risk-based Supplier Management program

Creating a Risk-based Supplier Management program

  • Speaker: Betty Lane
  • Product ID: 702501
  • Duration: 75 Min
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
CD/Recorded
$249
Recorded/CD
Implementing the New Usability Engineering Standard

Implementing the New Usability Engineering Standard

  • Speaker: Daniel O Leary
  • Product ID: 704894
  • Duration: 90 Min
Usability Engineering has become a major topic. The current standard tightens the linkage to risk management. In addition, there are changes in the US and EU approach, all of which find a basis in this standard. Attending this presentation provides the information you need to prepare for these major changes.
CD/Recorded
$279
Recorded/CD
The FDA Compliance Enforcement Process

The FDA Compliance Enforcement Process

  • Speaker: David L Chesney
  • Product ID: 704913
  • Duration: 90 Min
This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.
Recorded/CD
Medical Device Complaints, MDR's and Recalls

Medical Device Complaints, MDR's and Recalls

  • Speaker: John Chapman
  • Product ID: 700196
  • Duration: 60 Min
This training program on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.
CD/Recorded
$249
Recorded/CD
Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals

Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals

  • Speaker: David Lim
  • Product ID: 702318
  • Duration: 120 Min
This webinar will discuss requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. It is designed to help the audience develop, maintain and implement adequate procedures.
CD/Recorded
$249
Recorded/CD
Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries

Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries

  • Speaker: Shahbaz Shahbazi,Ray Bandziulis
  • Product ID: 702614
  • Duration: 75 Min
This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.
CD/Recorded
$229
Recorded/CD
Medical Device: Risk Assessment and Mitigation through FMEA

Medical Device: Risk Assessment and Mitigation through FMEA

  • Speaker: Dev Raheja
  • Product ID: 702321
  • Duration: 90 Min
This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.
CD/Recorded
$229
Recorded/CD
ISO 13485 and medical device quality systems - practical strategies for planning, implementation and beyond

ISO 13485 and medical device quality systems - practical strategies for planning, implementation and beyond

  • Speaker: Cathie Rutt ,Nancy Ruth
  • Product ID: 702036
  • Duration: 70 Min
This medical device quality systems training will show how you can design and maintain your quality system to meet requirements to target the US, Canada and EU.
CD/Recorded
$249
Recorded/CD
3hr Virtual Seminar on Designing Medical Device Software to Prevent Product Recalls

3hr Virtual Seminar on Designing Medical Device Software to Prevent Product Recalls

  • Speaker: Dev Raheja
  • Product ID: 701954
  • Duration: 180 Min
This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.
CD/Recorded
$799
Recorded/CD
Recent Major Industry CGMP Failures - Lessons Learned

Recent Major Industry CGMP Failures - Lessons Learned

  • Speaker: John E Lincoln
  • Product ID: 701897
  • Duration: 105 Min
This cGMP webinar for medical device companies will focus on recent manufacturing lapses that have resulted in major recalls, multi-million dollar fines and some criminal charges. It will analyze why they happened and show how to prevent it.
CD/Recorded
$545
Recorded/CD
Recalls of Medical Devices in the US

Recalls of Medical Devices in the US

  • Speaker: Edwin L Bills
  • Product ID: 701700
  • Duration: 80 Min
In this Medical device recall training learn how to interface with FDA in regards to anticipated recalls, the communication, the response, how to prepare the public information.
CD/Recorded
$25
Recorded/CD
How to Manage a Medical Device Recall Efficiently and Effectively

How to Manage a Medical Device Recall Efficiently and Effectively

  • Speaker: David Dills
  • Product ID: 700911
  • Duration: 64 min
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
CD/Recorded
$25
Recorded/CD
Development and Audit of Complaint Handling and MDR Processes

Development and Audit of Complaint Handling and MDR Processes

  • Speaker: Jeff Kasoff
  • Product ID: 701287
  • Duration: 60 Min
This Medical device training will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action.
Recorded/CD
How CAPA and complaint handling should interact in Medical Device - Simplification of the processes is often needed to preserve their effectiveness

How CAPA and complaint handling should interact in Medical Device - Simplification of the processes is often needed to preserve their effectiveness

  • Speaker: Nicolaas Besseling
  • Product ID: 701314
  • Duration: 60 Min
This CAPA training/webinar for Medical device will guide you how CAPA and complaint handling should interact in Medical Device and it will mention the Differences between the FDA's approach and the ISO approach.
CD/Recorded
$299
Recorded/CD
Medical Device Complaint Handling: Solving Your Toughest Reporting Problems

Medical Device Complaint Handling: Solving Your Toughest Reporting Problems

  • Speaker: Dennis Moore
  • Product ID: 701192
  • Duration: 60 Min
This Medical device training will review the sections of the QS Reg. Complaint handling rules and will help you avoid FDA 483’s and warning letters.
CD/Recorded
$299
Best Sellers
You Recently Viewed
    Loading