ComplianceOnline

Medical Device Risk 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
Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
17
/ Jan
Thursday-2019

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

  • Speaker: Tanvir Mahmud
  • Product ID: 702422
  • Duration: 90 Min
This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
* Per Attendee
$199
Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9
13
/ Feb
Wednesday-2019

Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9

  • Speaker: John E Lincoln
  • Product ID: 701693
  • Duration: 60 Min
In this product risk management webinar attendees will understand the key requirements of ISO 14971 (2007 and 2012) and ICH Q9. Also attendees will learn how to develop and implement product risk management planning through ISO 14971 & ICH Q9 to increase the product safety and reduced liability.
* Per Attendee
$199
Introduction to Root Cause Investigation for CAPA
21
/ Feb
Thursday-2019

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.
* Per Attendee
$179
Failure Modes and Effects Analysis - An effective Risk Management Tool
7
/ Mar
Thursday-2019

Failure Modes and Effects Analysis - An effective Risk Management Tool

  • Speaker: John Chapman
  • Product ID: 701138
  • Duration: 60 Min
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
Recorded/CD
The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

  • Speaker: John E Lincoln
  • Product ID: 705111
  • Duration: 90 Min
This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”. It will touch on “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Another webinar will focus on Part 2, and re-evaluate key portions of Part-1.
CD/Recorded
$249
Recorded/CD
CGMP controlled Raw Materials

CGMP controlled Raw Materials

  • Speaker: Charity Ogunsanya
  • Product ID: 705148
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
CD/Recorded
$249
Recorded/CD
Process Verification and Validation Planning and Execution

Process Verification and Validation Planning and Execution

  • Speaker: John E Lincoln
  • Product ID: 701662
  • Duration: 60 Min
This 60-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
CD/Recorded
$249
Recorded/CD
How to Prepare for the New EU Medical Device Regulations

How to Prepare for the New EU Medical Device Regulations

  • Speaker: Richard Young
  • Product ID: 705513
  • Duration: 90 Min
The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.
CD/Recorded
$279
Recorded/CD
Complaint Management: Best Practices to Assure Compliance and Customer Retention

Complaint Management: Best Practices to Assure Compliance and Customer Retention

  • Speaker: Jeff Kasoff
  • Product ID: 700986
  • Duration: 60 Min
This training will detail how you can handle customer complaints in compliance with FDA and ISO regulations. The instructor will discuss topics like best practices for documenting customer feedback, what constitutes a complaint, what to do with non-complaint feedback, and how to include complaint trending into your firm’s CAPA program.
CD/Recorded
$249
Recorded/CD
Post-market Surveillance - Clinical Evaluation and Risk Management

Post-market Surveillance - Clinical Evaluation and Risk Management

  • Speaker: Daniel O Leary
  • Product ID: 705402
  • Duration: 90 Min
This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.
CD/Recorded
$249
Recorded/CD
Medical Device Software Verification and Validation

Medical Device Software Verification and Validation

  • Speaker: Nancy Knettell
  • Product ID: 705393
  • Duration: 60 Min
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
CD/Recorded
$249
Recorded/CD
Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

  • Speaker: Edwin Waldbusser
  • Product ID: 705432
  • Duration: 60 Min
This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.
Recorded/CD
Develop a Device Master Record that can assist with Device History Record Review

Develop a Device Master Record that can assist with Device History Record Review

  • Speaker: Mary Nunnally
  • Product ID: 705328
  • Duration: 60 Min
This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.
Recorded/CD
Whistle While You Work: Protecting Your Organization from Whistleblower Threats

Whistle While You Work: Protecting Your Organization from Whistleblower Threats

  • Speaker: Christine Zack
  • Product ID: 705413
  • Duration: 60 Min
This webinar will provide an overview of SEC Whistleblower Rules such as False Claims Act, Dodd-Frank, Sarbanes-Oxley and Commodity Exchange Act. It will also discuss best practices on how to mitigate damages from an actual or purported whistleblower.
Recorded/CD
How to prepare a winning Standard Operating Procedure (SOP)

How to prepare a winning 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.
Recorded/CD
Project Risk Management

Project Risk Management

  • Speaker: Mario Mosse
  • Product ID: 705015
  • Duration: 90 Min
Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.
CD/Recorded
$229
Recorded/CD
Life Cycle Risk Management for 21 CFR 820 and ISO 13485

Life Cycle Risk Management for 21 CFR 820 and ISO 13485

  • Speaker: Russell Pizzuto
  • Product ID: 704964
  • Duration: 90 Min
This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR 820 and ISO 13485.
Recorded/CD
Device Design and Risk Management

Device Design and Risk Management

  • Speaker: Daniel O Leary
  • Product ID: 704561
  • Duration: 90 Min
As medical device requirements and expectations increase, coupled with strengthened standards, the design project must seek every opportunity to leverage activities in the area to satisfy requirements in other areas. This reduces the total work and helps make these processes more efficient. By attending this presentation, you will learn techniques to improve your device design project.
Recorded/CD
Risk Assessment in Medical Device Development

Risk Assessment in Medical Device Development

  • Speaker: Charles H Paul
  • Product ID: 704803
  • Duration: 90 Min
This medical device risk assessment webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective device Risk or Hazard Analysis.
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