WEBINARS

 

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

Creating a Risk-based Supplier Management program

webinar-speaker   Betty Lane

webinar-time   75 Min

Product Id: 702501

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.

Recording Available

* Per Attendee $299

 

Complaint Handling, MDR's & Recalls

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700830

This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

Recording Available

* Per Attendee $299

 

Human Factors Engineering in New Product Development

webinar-speaker   Tom Kramer

webinar-time   120 Min

Product Id: 705153

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.

Recording Available

* Per Attendee $249

 

Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 701788

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700322

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.

Recording Available

* Per Attendee $25

 

Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 703752

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.

Recording Available

 

Implementing the New Usability Engineering Standard

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 704894

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.

Recording Available

* Per Attendee $279

 

The FDA Compliance Enforcement Process

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 704913

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.

Recording Available

 

Medical Device Complaints, MDR's and Recalls

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700196

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   David Lim

webinar-time   120 Min

Product Id: 702318

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Shahbaz Shahbazi,Ray Bandziulis

webinar-time   75 Min

Product Id: 702614

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.

Recording Available

* Per Attendee $229

 

Medical Device: Risk Assessment and Mitigation through FMEA

webinar-speaker   Dev Raheja

webinar-time   90 Min

Product Id: 702321

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Cathie Rutt ,Nancy Ruth

webinar-time   70 Min

Product Id: 702036

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Dev Raheja

webinar-time   180 Min

Product Id: 701954

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.

Recording Available

* Per Attendee $799

 

Recent Major Industry CGMP Failures - Lessons Learned

webinar-speaker   John E Lincoln

webinar-time   105 Min

Product Id: 701897

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.

Recording Available

* Per Attendee $545

 

Recalls of Medical Devices in the US

webinar-speaker   Edwin L Bills

webinar-time   80 Min

Product Id: 701700

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.

Recording Available

* Per Attendee $50

 

How to Manage a Medical Device Recall Efficiently and Effectively

webinar-speaker   David Dills

webinar-time   64 min

Product Id: 700911

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.

Recording Available

* Per Attendee $50

 

Development and Audit of Complaint Handling and MDR Processes

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 701287

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.

Recording Available

 

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

webinar-speaker   Nicolaas Besseling

webinar-time   60 Min

Product Id: 701314

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.

Recording Available

* Per Attendee $299

 

Medical Device Complaint Handling: Solving Your Toughest Reporting Problems

webinar-speaker   Dennis Moore

webinar-time   60 Min

Product Id: 701192

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.

Recording Available

* Per Attendee $299

 

 

 

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