ComplianceOnline
Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in Your Company Required by the EU MDR Regulation
6
/ Jul
Monday-2020

Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in Your Company Required by the EU MDR Regulation

  • Speaker: Frank Stein
  • Product ID: 706532
  • Duration: 90 Min
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One of those requirements is Article 15 Responsible Person for Regulatory Compliance. That role is a little bit similar to the role of the Qualified Person in the Pharma Industry but not the same and the new role is not the same as the Quality Representative for the quality management system. Your company must implement the new role in the organization structure and in the processes and take care of the qualification requirements.
* Per Attendee
$349
GXP: Quality Standards and Regulations for the Medical Device Field
10
/ Jul
Friday-2020

GXP: Quality Standards and Regulations for the Medical Device Field

  • Speaker: James W Monroe
  • Product ID: 706494
  • Duration: 60 Min
This webinar will discuss and define GXP’s, where the variable “x”, is Laboratory, Clinical, or Manufacturing. The webinar will focus on the requirements for each, and how they relate to the total product lifecycle, compliance, and inspections.
* Per Attendee
$329
Good Documentation Guideline (Chapter <1029> USP)
14
/ Jul
Tuesday-2020

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.
* Per Attendee
$229
How to Create A PMS Plan and Report According to EU MDR 2017/745 Article 83-86?
15
/ Jul
Wednesday-2020

How to Create A PMS Plan and Report According to EU MDR 2017/745 Article 83-86?

  • Speaker: Frank Stein
  • Product ID: 706533
  • Duration: 90 Min
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the "Post-Market- Surveillance-Process" and the new requirements e.g. reporting to Competent Authorities and Notified Bodies and how this process is connected to other processes in the quality management system according to ISO 13485:2016. The understanding of these changes and how to implement changes until May 2021 is essential to keep your certificates and to keep the market entry open.
* Per Attendee
$349
Metrics for a Suitable and Effective Quality Management System
15
/ Jul
Wednesday-2020

Metrics for a Suitable and Effective Quality Management System

  • Speaker: Susanne Manz
  • Product ID: 706489
  • Duration:
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.
* Per Attendee
$349
Supplier Management with the new Medical Device Regulation EU MDR 745/2017
16
/ Jul
Thursday-2020

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

  • Speaker: Frank Stein
  • Product ID: 706068
  • Duration: 90 Min
In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.
* Per Attendee
$249
Japan: Regulatory Compliance Requirements for Life Science Products
21
/ Jul
Tuesday-2020

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
* Per Attendee
$249
Successful 510(k) Submissions
22
/ Jul
Wednesday-2020

Successful 510(k) Submissions

  • Speaker: John E Lincoln
  • Product ID: 700815
  • Duration: 60 Min
In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.
* Per Attendee
$329
Audit 3.0: Audit/Auditing Fundamentals for the 21st Century
31
/ Jul
Friday-2020

Audit 3.0: Audit/Auditing Fundamentals for the 21st Century

  • Speaker: James W Monroe
  • Product ID: 706495
  • Duration: 60 Min
Whether you are being audited or conducting and audit, understanding the fundamental is critical for both quality system and regulatory compliance. In this webinar we will examine the concepts of conducting audits and being the subject of an audit (internal or external).
* Per Attendee
$329
Spotlight on Complaint Handling and Medical Device Reporting
19
/ Aug
Wednesday-2020

Spotlight on Complaint Handling and Medical Device Reporting

  • Speaker: Susanne Manz
  • Product ID: 706099
  • Duration: 90 Min
This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.
* Per Attendee
$249
How to Prepare a Standard Operating Procedure (SOP)?
15
/ Sep
Tuesday-2020

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
Medical Device Recalls - a Prevention Strategy
29
/ Sep
Tuesday-2020

Medical Device Recalls - a Prevention Strategy

  • Speaker: Charles H Paul
  • Product ID: 706537
  • Duration: 60 Min
The rough breakdown of medical device failures is 60% residing with the product specification and only 30% of the errors in the components themselves. This rough breakdown indicates that most of the problems are referred to as management errors – caused by faulty systems, processes, and conditions. A failure of procedures and execution. In other words, management failure. In this webinar, learn the strategies to prevent such medical device recalls.
* Per Attendee
$329
Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP
30
/ Sep
Wednesday-2020

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

  • Speaker: John E Lincoln
  • Product ID: 700817
  • Duration: 60 Min
This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.
* Per Attendee
$329
Attaining Your CE Mark for Your Medical Device in the EU
18
/ Nov
Wednesday-2020

Attaining Your CE Mark for Your Medical Device in the EU

  • Speaker: Charles H Paul
  • Product ID: 706543
  • Duration: 60 Min
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). By placing the CE mark on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements necessary to achieve CE marking status. With that mark, the manufacturer is ensuring validity for that product to be sold throughout the EEA. CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there.
* Per Attendee
$329
Recorded/CD
Understanding, Calculating, and Using Statistical Power in Sample Size Determinations for Significance Tests

Understanding, Calculating, and Using Statistical Power in Sample Size Determinations for Significance Tests

  • Speaker: John N Zorich
  • Product ID: 706176
  • Duration: 90 Min
Calculation of power is so complicated that it typically must be done with a software program. Even so, the software program's output can be misunderstood unless the user has a firm understanding of the basic concept of statistical power. This seminar helps the attendee to understand and use the output of power calculations, to determine adequate sample sizes and to determine whether or not a product or process meets requirements.
CD/Recorded
$399
Recorded/CD
Statistical Tolerance Intervals & Limits: What, Why, How, & Alternatives

Statistical Tolerance Intervals & Limits: What, Why, How, & Alternatives

  • Speaker: John N Zorich
  • Product ID: 706349
  • Duration: 90 Min
This webinar explains the practical use and theoretical basis of Statistical Tolerance Intervals and Statistical Tolerance Limits. It explains the difference between non-statistical tolerance limits and statistical ones. It explains the difference between "identifying the distribution" and "transforming the data". You will learn how "Normal Tolerance Intervals" are calculated, and how to transform non-normal data into Normality, how to calculate Statistical Tolerance Intervals for data that cannot be transformed to Normality. And it recommends an alternative method to using Statistical Tolerance Intervals.
CD/Recorded
$299
Recorded/CD
Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies

Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies

  • Speaker: John N Zorich
  • Product ID: 706189
  • Duration: 90 Min
This webinar provides guidance on how to justify sample sizes, and thereby indirectly provides guidance on how to choose sample sizes. Those justifications can then be documented in Protocols or regulatory submissions or can be given to regulatory auditors who may ask for them during onsite audits at your company. Thus, this webinar is designed to help you avoid regulatory delays in product approvals and to prevent an auditor from issuing you a nonconformity.
CD/Recorded
$299
Recorded/CD
Metrology - Statistical Analysis of Measurement Uncertainty

Metrology - Statistical Analysis of Measurement Uncertainty

  • Speaker: John N Zorich
  • Product ID: 706202
  • Duration: 90 Min
Attend this webinar to learn about the fundamental vocabulary and concepts related to metrology including accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation including Gage R&R, Gage Correlation, Gage Linearity, and Gage Bias described and explained. You will learn how to combine all relevant uncertainty information into an "Uncertainty Budget" to determine the appropriate width of QC specification intervals (i.e., "guard-banded specifications").
CD/Recorded
$299
Recorded/CD
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

  • Speaker: Frank Stein
  • Product ID: 706121
  • Duration: 90 Min
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union.
CD/Recorded
$299
Recorded/CD
How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

  • Speaker: Javier Kuong
  • Product ID: 700095
  • Duration: 120 Min
This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise.
CD/Recorded
$249
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