ComplianceOnline

Medical Device GxP Regulations 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
Cell Based Assays: Development and Validation
16
/ Jan
Wednesday-2019

Cell Based Assays: Development and Validation

  • Speaker: Michael Simonian
  • Product ID: 704528
  • Duration: 60 Min
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
* Per Attendee
$199
Data Governance for Computer Systems Regulated by FDA
23
/ Jan
Wednesday-2019

Data Governance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 704745
  • Duration: 60 Min
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
* 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
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
26
/ Feb
Tuesday-2019

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

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 90 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
$199
Supplier and Service Provider Controls: FDA Expectations
6
/ Mar
Wednesday-2019

Supplier and Service Provider Controls: FDA Expectations

  • Speaker: Vanessa Lopez
  • Product ID: 704844
  • Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
* Per Attendee
$249
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
$249
Recorded/CD
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

  • Speaker: John E Lincoln
  • Product ID: 704848
  • Duration: 90 Min
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
CD/Recorded
$249
Recorded/CD
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
CD/Recorded
$249
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
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

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.
CD/Recorded
$249
Recorded/CD
Medical Device Tracking Requirements

Medical Device Tracking Requirements

  • Speaker: Vanessa Lopez
  • Product ID: 705192
  • Duration: 60 Min
Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.
CD/Recorded
$249
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
$249
Recorded/CD
Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

  • Speaker: John R Godshalk
  • Product ID: 704806
  • Duration: 60 Min
This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
CD/Recorded
$249
Recorded/CD
Performing Effective Management Review of the Quality System

Performing Effective Management Review of the Quality System

  • Speaker: David L Chesney
  • Product ID: 704933
  • Duration: 90 Min
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.
CD/Recorded
$249
Recorded/CD
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

  • Speaker: Joy McElroy
  • Product ID: 704531
  • Duration: 120 Min
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
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
Environmental Monitoring (EM) Program Basics

Environmental Monitoring (EM) Program Basics

  • Speaker: Joy McElroy
  • Product ID: 704377
  • Duration: 60 Min
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
CD/Recorded
$249
Recorded/CD
Computer System Validation and Part 11 Compliance

Computer System Validation and Part 11 Compliance

  • Speaker: Joy McElroy
  • Product ID: 705427
  • Duration: 60 Min
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.
Recorded/CD
How to Analyze PQ Data with Multiple Populations/ Failure Modes using Minitab®

How to Analyze PQ Data with Multiple Populations/ Failure Modes using Minitab®

  • Speaker: Jerry Phillips
  • Product ID: 705281
  • Duration: 90 Min
This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.
CD/Recorded
$249
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