WEBINARS

 

Medical Device QMS, ISO 13485 Requirements and CAPA Regulatory Compliance Training - Live Webinars, Recordings & CDs

Integrating Risk Management into the CAPA System

webinar-speaker   Edwin L Bills

webinar-time   90 Min

Product Id: 700525

This webinar will explain what FDA expects in incorporating risk in the CAPA process, what strategies can be used to assign resources to CAPA activities, and how to manage multi-level CAPA processes so that they will not run afoul of the FDA during inspections

Recording Available

* Per Attendee $229

 

The Use and Mis-use of FMEA in Medical Device Risk Management

webinar-speaker   Edwin L Bills

webinar-time   60 Min

Product Id: 700621

The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process. Most medical device manufacturers use FMEA as a part of their risk management system. Most medical device manufacturers use FMEA as a part of their risk management system.

Recording Available

* Per Attendee $149

 

Equipment Requalification: What and When it is Really Required?

webinar-speaker   Jennifer Medlar

webinar-time   60 Min

Product Id: 703450

This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.

Recording Available

* Per Attendee $229

 

Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

webinar-speaker   Les Schnoll

webinar-time   90 Min

Product Id: 703433

This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.

Recording Available

* Per Attendee $50

 

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700254

This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.

Recording Available

* Per Attendee $229

 

Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 701003

This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.

Recording Available

* Per Attendee $229

 

Are you prepared for a regulatory audit from FDA or any other regulatory body?

webinar-speaker   Philip Russ

webinar-time   90 Min

Product Id: 703355

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

Recording Available

* Per Attendee $229

 

US FDA 510(k): Best Practices for 510(k) Preparation and Submission

webinar-speaker   David Lim

webinar-time   60 Min

Product Id: 703218

This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.

Recording Available

* Per Attendee $229

 

Supplier Quality Agreements for Medical Devices

webinar-speaker   Dan OLeary

webinar-time   90 Min

Product Id: 702848

This training on medical device supplier management will explain the elements of a supplier quality agreement and discuss practical steps for implementation.

Recording Available

* Per Attendee $229

 

Process Capability Indices in Medical Device Manufacturing

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 703141

This webinar will help device manufacturers to identify valid statistical techniques to control process capability and product characteristics. It will explain process capability indices in detail and their use.

Recording Available

* Per Attendee $229

 

Transferring Medical Device Production to a Contract Manufacturer - Decision Making Process and Procedures

webinar-speaker   Rob Braido

webinar-time   90 Min

Product Id: 702719

This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail the options and next steps to transferring it to the right facility or contract manufacturer.

Recording Available

* Per Attendee $229

 

Managing the Software Development Life Cycle to Produce Regulatory Documentation (for Medical Devices)

webinar-speaker   Tim Stein

webinar-time   60 Min

Product Id: 703158

This webinar will discuss regulatory requirements for the medical device software development process and how the documentation needed for MDD technical files and for FDA submission can be developed as part of that process.

Recording Available

* Per Attendee $229

 

Clinical Importance of Objectionable Organisms

webinar-speaker   Ziva Abraham

webinar-time   60 Min

Product Id: 703072

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

Recording Available

 

2-in-1 Virtual Seminar: FDA's Strategic Priorities and Supplier Control Requirements

webinar-speaker   John E Lincoln

webinar-time   3.5 hrs

Product Id: 703052

This virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.

Recording Available

* Per Attendee $499

 

Equipment Calibration in FDA QSR - Regulations and Warning Letters

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 702268

This webinar explains concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. It defines the concepts of accuracy and precision that define the measuring equipment’s requirements. It also explains the meaning of traceability.

Recording Available

* Per Attendee $229

 

Essential Last Minute Preparation for an Imminent FDA Inspection

webinar-speaker   Chris Cook

webinar-time   60 Min

Product Id: 703004

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

Recording Available

* Per Attendee $229

 

Global Medical Device Laws and Regulations: US, EU, and Canada

webinar-speaker   David Lim

webinar-time   90 Min

Product Id: 702842

This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.

Recording Available

* Per Attendee $50

 

Medical Device Reporting for Manufacturers, Importers and Medical Device User Facilities

webinar-speaker   Kosta Makrodimitris

webinar-time   90 Min

Product Id: 702958

This webinar on Medical Device Reporting (MDR) will cover FDA requirements for importers, manufacturers and hospitals to report medical device adverse events. It will discuss current policies and guidances for Medical Device Reporting and provide update on upcoming regulations.

Recording Available

* Per Attendee $149

 

Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea

webinar-speaker   David Lim

webinar-time   90 Min

Product Id: 702841

This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.

Recording Available

* Per Attendee $229

 

FDA Warning Letters - Stop Fumbling your Response and Effectively Demonstrate Compliance

webinar-speaker   Marc Sanchez

webinar-time   60 Min

Product Id: 702797

This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.

Recording Available

* Per Attendee $229

 

 

 

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