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Home › Online Training ›  Medical device Training

Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

Sub Categories: Risk Management | GXP Medical Devices | Marketing and Promotion | Testing and Validation | Audits & Inspections | IVD | Sterilization | Crisis Management | QMS, ISO 13485, CAPA | Supply Chain and Manufacturing | R & D | Regulations & Guidances | Documentation and Data Management
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Metrology - Statistical Analysis of Measurement Uncertainty
17
/ Oct
Thursday-2019

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").
* Per Attendee
$249
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How to write SOP's that Avoid Human Error
17
/ Oct
Thursday-2019

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.
* Per Attendee
$249
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Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU
18
/ Oct
Friday-2019

Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU

  • Speaker: Robert J Russell
  • Product ID: 701369
  • Duration: 90 Min
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
* Per Attendee
$249
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Managing Non-conforming Material and Failure Investigations
23
/ Oct
Wednesday-2019

Managing Non-conforming Material and Failure Investigations

  • Speaker: Susanne Manz
  • Product ID: 706245
  • Duration: 90 Min
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.
* Per Attendee
$249
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US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
23
/ Oct
Wednesday-2019

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

  • Speaker: John E Lincoln
  • Product ID: 705794
  • Duration: 60 Min
Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.
* Per Attendee
$229
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Good Documentation Guideline (Chapter <1029> USP)
24
/ Oct
Thursday-2019

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
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EU IVDR 2017/746 - the new EU regulation for invitro diagnostic
31
/ Oct
Thursday-2019

EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

  • Speaker: Frank Stein
  • Product ID: 706170
  • Duration: 90 Min
Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.
* Per Attendee
$249
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Reduce Compliance and Recordkeeping Burdens
4
/ Nov
Monday-2019

Reduce Compliance and Recordkeeping Burdens

  • Speaker: Susanne Manz
  • Product ID: 706248
  • Duration: 90 Min
This webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. It will get you started in setting up a quality system that reduces compliance burden. We’ll. discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS.
* Per Attendee
$249
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Powerful Closed-loop CAPA - Meeting FDA Expectations
6
/ Nov
Wednesday-2019

Powerful Closed-loop CAPA - Meeting FDA Expectations

  • Speaker: John E Lincoln
  • Product ID: 702012
  • Duration: 90 Min
This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.
* Per Attendee
$249
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Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
12
/ Nov
Tuesday-2019

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
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Introduction to SPC (Statistical Process Control)
14
/ Nov
Thursday-2019

Introduction to SPC (Statistical Process Control)

  • Speaker: John N Zorich
  • Product ID: 706230
  • Duration: 90 Min
Attend this webinar to learn how to use SPC to meet ISO requirements for "continual improvement" as well as FDA requirements to "control and monitor production processes". It introduces SPC, using Xbar-R charts as an example.
* Per Attendee
$249
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Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
19
/ Nov
Tuesday-2019

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
* Per Attendee
$249
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How to Prepare a Standard Operating Procedure (SOP)?
19
/ Nov
Tuesday-2019

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
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You have a BI Positive or Product Sterility Positive - Now What?
19
/ Nov
Tuesday-2019

You have a BI Positive or Product Sterility Positive - Now What?

  • Speaker: Gerry O Dell
  • Product ID: 703288
  • Duration: 60 Min
This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation.
* Per Attendee
$229
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Changes in the upcoming Standard ISO 14971:2019
22
/ Nov
Friday-2019

Changes in the upcoming Standard ISO 14971:2019

  • Speaker: Bijan Elahi
  • Product ID: 706257
  • Duration: 60 Min
The third revision of ISO 14971 will be released in Q4, 2019. Upon release it will cancel and replace ISO 14971:2007. In this webinar you will learn what has changed and how to prepare for compliance to the new Standard.
* Per Attendee
$229
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Recorded/CD
Managing Multi Track Audits

Managing Multi Track Audits

  • Speaker: Deb Simpson
  • Product ID: 706206
  • Duration: 90 Min
This course will prepare you to manage multiple auditors and audit teams for audits with multiple evaluation paths (tracks). This includes How to prepare your Audit Leaders and Subject Matter Experts (SME), How to prepare your Back Room (Work Room) staff, How to prepare a comprehensive schedule to ensure the right people are in the right place at the right time during the audit. Although this course is focused on multiple track audits for the Medical Device or Life Sciences industry, the process and tools defined in this course can be applied to any audit.
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Recorded/CD
Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

  • Speaker: Steven Wachs
  • Product ID: 705020
  • Duration: 90 Min
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
CD/Recorded
$299
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Recorded/CD
Normality Tests and Normality Transformations: Explanations, Justifications, and Uses

Normality Tests and Normality Transformations: Explanations, Justifications, and Uses

  • Speaker: John N Zorich
  • Product ID: 706175
  • Duration: 90 Min
The calculations used in many statistical tests and methods require that the inputted data be “normally distributed”. This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data, and how to justify the transformations to internal and external quality system auditors.
CD/Recorded
$299
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Recorded/CD
Root Cause Analysis - The Heart of Corrective Action

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
CD/Recorded
$299
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Recorded/CD
Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

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.
CD/Recorded
$299
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