ComplianceOnline
All About UOUP (Usability of Unknown Provenance) A Guide to Creating a Usability Engineering File Retrospectively
25
/ Feb
Thursday-2021

All About UOUP (Usability of Unknown Provenance) A Guide to Creating a Usability Engineering File Retrospectively

  • Speaker: Elizabeth Bononno
  • Product ID: 706625
  • Duration: 90 Min
This webinar will discuss Usability of Unknown Provenance (UOUP) as described in Annex C of IEC62366-1 Application of usability engineering to medical devices (2_2015). Understanding the deliverables described in the standard can lead to the successful retrospective Human Factors documentation and provision of objective evidence that the required deliverables have been achieved for a commercialized medical device.
* Per Attendee
$249
How to Prepare a Standard Operating Procedure (SOP)?
10
/ Mar
Wednesday-2021

How to Prepare a 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.
* Per Attendee
$229
Incorporating Human Factors into the Risk Management Process
16
/ Mar
Tuesday-2021

Incorporating Human Factors into the Risk Management Process

  • Speaker: Elizabeth Bononno
  • Product ID: 706643
  • Duration: 90 Min
This webinar will discuss how to integrate Human Factors Engineering into the Risk Management process as per the requirements of the FDA’s Guidance for Applying Human Factors and Usability Engineering to Medical Devices (2_2016) and IEC62366-1 Application of usability engineering to medical devices (2_2015) and ISO 14971 Medical devices - Application of risk management to medical devices (12_2019). Both Human Factors Engineering and Risk Management standards are complementary in their goals to reduce the safety risks associated with medical devices to levels as low as reasonably possible. This webinar presents organizations with opportunities and insights on how to align and streamline their approach.
* Per Attendee
$249
Validation Essentials for Medical Device Manufacturers -  IQ, OQ, PQ
16
/ Mar
Tuesday-2021

Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ

  • Speaker: Susanne Manz
  • Product ID: 705972
  • Duration: 90 Min
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
* Per Attendee
$249
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
18
/ Mar
Thursday-2021

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
* Per Attendee
$229
User Needs - Creation to Design Validation
18
/ Mar
Thursday-2021

User Needs - Creation to Design Validation

  • Speaker: Elizabeth Bononno
  • Product ID: 706644
  • Duration: 90 Min
A key aspect of developing a medical device that users find safe, efficient, effective, delightful (and a host of other adjectives) is understanding what users need. This webinar discusses approaches to creating and validating user needs and the role of Human Factors Engineering throughout the design and development process.
* Per Attendee
$249
Medical Device Cybersecurity Risk Management Training
22
/ Mar
Monday-2021

Medical Device Cybersecurity Risk Management Training

  • Speaker: Frank Stein
  • Product ID: 706560
  • Duration: 3 hrs
This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
* Per Attendee
$329
QA Agreements for ISO 13485:2019 and other Regulatory Compliance
24
/ Mar
Wednesday-2021

QA Agreements for ISO 13485:2019 and other Regulatory Compliance

  • Speaker: Betty Lane
  • Product ID: 703515
  • Duration: 60 Min
In this webinar you will learn how to create detailed quality agreements (QA Agreements) for key suppliers, particularly those for outsourced processes, and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485:2016 and MDSAP. The agreements discussed will meet the expectations of the GHTF and NBOG supplier guidance documents which are now an expectation of both the FDA and most ISO 13485 auditors. These supplier QA agreements can be an important part of demonstrating that you have control of your key suppliers.
* Per Attendee
$199
Introduction to Medical Device Quality System Regulations
25
/ Mar
Thursday-2021

Introduction to Medical Device Quality System Regulations

  • Speaker: Paul Larocque
  • Product ID: 706648
  • Duration: 90 Min
In this webinar, you will get an overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.
* Per Attendee
$249
How FDA trains its investigators to review CAPA and what should you do to prepare
26
/ Mar
Friday-2021

How FDA trains its investigators to review CAPA and what should you do to prepare

  • Speaker: Jeff Kasoff
  • Product ID: 700851
  • Duration: 60 Min
This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.
* Per Attendee
$199
Recorded/CD
All About UOUP (Usability of Unknown Provenance) A Guide to Creating a Usability Engineering File Retrospectively

All About UOUP (Usability of Unknown Provenance) A Guide to Creating a Usability Engineering File Retrospectively

  • Speaker: Elizabeth Bononno
  • Product ID: 706634
  • Duration: 90 Min
This webinar will discuss Usability of Unknown Provenance (UOUP) as described in Annex C of IEC62366-1 Application of usability engineering to medical devices (2_2015). Understanding the deliverables described in the standard can lead to the successful retrospective Human Factors documentation and provision of objective evidence that the required deliverables have been achieved for a commercialized medical device.
Recorded/CD
Design Control for Medical Devices Including Verification/Validation

Design Control for Medical Devices Including Verification/Validation

  • Speaker: Alan M Golden
  • Product ID: 706619
  • Duration: 60 Min
Overview of design control for medical devices with and emphasis on verification and validation of design inputs. Webinar will cover basic regulations regarding verification/validation of inputs, trace of inputs to verification/validation and techniques including statistics for proper verification/validation of design inputs.
Recorded/CD
Supplier Management: How to meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner

Supplier Management: How to meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner

  • Speaker: Jeff Kasoff
  • Product ID: 700193
  • Duration: 60 Min
Attend this webinar to learn the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.
CD/Recorded
$299
Recorded/CD
Integrating Human Factors Engineering into the Product Development Lifecycle

Integrating Human Factors Engineering into the Product Development Lifecycle

  • Speaker: Elizabeth Bononno
  • Product ID: 706624
  • Duration: 90 Min
This webinar will discuss how to integrate Human Factors Engineering into the product development lifecycle of an organization as per the requirements of the FDA’s Guidance for Applying Human Factors and Usability Engineering to Medical Devices (2_2016) and IEC62366-1 Application of usability engineering to medical devices (2_2015). Understanding the deliverables described in these standards can lead to the successful creation of standard operating procedures, the ability to accurately determine the scope of work and necessary budget, appropriate project deliverables and organizational buy-in.
Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
CD/Recorded
$299
Recorded/CD
Metrics for a Suitable and Effective Quality Management System

Metrics for a Suitable and Effective Quality Management System

  • Speaker: Susanne Manz
  • Product ID: 706489
  • Duration: 90 Min
Metrics and data are a key part of Management Review. Management needs to know how the quality system is performing, where the risks are, and where to invest precious dollars and resources for improvement. This course can help you determine what to measure, how to present information, and how to escalate issues for management review.
CD/Recorded
$399
Recorded/CD
Design Control for Medical Devices: Overview and Design Inputs

Design Control for Medical Devices: Overview and Design Inputs

  • Speaker: Alan M Golden
  • Product ID: 706618
  • Duration: 60 Min
Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.
Recorded/CD
How to write SOP's that Avoid Human Error

How to write SOP's that Avoid Human Error

  • Speaker: Ginette M Collazo
  • Product ID: 704418
  • Duration: 90 Min
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
CD/Recorded
$299
Recorded/CD
Write it Right - Excellent SOPs for Improved Quality and Compliance

Write it Right - Excellent SOPs for Improved Quality and Compliance

  • Speaker: Susanne Manz
  • Product ID: 706471
  • Duration: 90 Min
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well written SOPs result in more consistent process outputs and quality results.
CD/Recorded
$299
Recorded/CD
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

  • Speaker: Frank Stein
  • Product ID: 706565
  • Duration: 4 Hrs
This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
CD/Recorded
$499
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