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.
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.
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.
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.
Daniel O Leary
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.
Daniel O Leary
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.
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.
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.
Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries
Shahbaz Shahbazi,Ray Bandziulis
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.
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.
ISO 13485 and medical device quality systems - practical strategies for planning, implementation and beyond
Cathie Rutt ,Nancy Ruth
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.
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.
John E Lincoln
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.
Edwin L Bills
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.
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.
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.
How CAPA and complaint handling should interact in Medical Device - Simplification of the processes is often needed to preserve their effectiveness
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.
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.