ComplianceOnline
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
9
/ Dec
Monday-2019

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
* Per Attendee
$249
FDA's Ambitious Regulation of Social Media
10
/ Dec
Tuesday-2019

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
* Per Attendee
$229
Introduction to Root Cause Investigation for CAPA
10
/ Dec
Tuesday-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
$229
NLRB Effects on  Social Media, Non-Union Employers and Other Changes
12
/ Dec
Thursday-2019

NLRB Effects on Social Media, Non-Union Employers and Other Changes

  • Speaker: Teri Morning
  • Product ID: 702604
  • Duration: 60 Min
This NLRA compliance webinar will discuss the fundamentals of NLRA and review how recent decisions of the National Labor Relations Board (NLRB) affects both non-union and union employers.
* Per Attendee
$179
Understanding, Calculating, and Using Statistical Power in Sample Size Determinations for Significance Tests
12
/ Dec
Thursday-2019

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.
* Per Attendee
$249
ISO 13485:2016 - What are the hot topics and changes?
13
/ Dec
Friday-2019

ISO 13485:2016 - What are the hot topics and changes?

  • Speaker: Frank Stein
  • Product ID: 705864
  • Duration: 90 Min
In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
* Per Attendee
$199
Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit
16
/ Dec
Monday-2019

Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit

  • Speaker: George Yanulis
  • Product ID: 706295
  • Duration: 90 Min
Premarket Approvals Premarket approval (PMA) are required by The Food and Drug Administration is the regulatory protocol presently used to evaluate the safety and effectiveness of Class III medical devices, e.g., an implantable cardioverter defibrillator (ICD). This webinar will help you understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. The information when applied is most effective in reducing potential adverse events.
* Per Attendee
$249
Medical Device Registration Requirements in Saudi Arabia and MEA
16
/ Dec
Monday-2019

Medical Device Registration Requirements in Saudi Arabia and MEA

  • Speaker: John Riggi
  • Product ID: 706291
  • Duration: 60 Min
This webinar will discuss the basics of product registration in Saudi Arabia and MEA such as Registration Timelines, documentation requirements and governmental processes.
* Per Attendee
$229
Purchasing Control Essentials for Medical Devices
7
/ Jan
Tuesday-2020

Purchasing Control Essentials for Medical Devices

  • Speaker: Susanne Manz
  • Product ID: 706266
  • Duration: 90 Min
This webinar will help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. You will gain an understanding of the regulations and learn to translate them into an efficient and effective process for purchasing/ supplier control. You will learn about the essential elements of purchasing control and how to translate them into your procedures, prevent quality and compliance problems by having a strong system for Purchasing Controls. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.
* Per Attendee
$249
Supplier Management with the new Medical Device Regulation EU MDR 745/2017
8
/ Jan
Wednesday-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
Confidence/Reliability & Tolerance Calculations for Extremely Non-Normal Data
9
/ Jan
Thursday-2020

Confidence/Reliability & Tolerance Calculations for Extremely Non-Normal Data

  • Speaker: John N Zorich
  • Product ID: 705908
  • Duration: 90 Min
Standard methods of statistical analysis of process capabilities require normally distributed data or transformations to normality. When that is impossible, due to data having a bimodal or other distribution, the only practical alternative to calculating a high level of confidence/reliability or an acceptable Tolerance limit is to use Reliability Plotting.
* Per Attendee
$249
Supplier and Service Provider Controls: FDA Expectations
9
/ Jan
Thursday-2020

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
$299
Understanding the Role of your Expert Witness
15
/ Jan
Wednesday-2020

Understanding the Role of your Expert Witness

  • Speaker: George Yanulis
  • Product ID: 706296
  • Duration: 90 Min
This webinar will provide you a thorough background into the FDA regulatory and EU control issue related to the specific device required to provide expert opinions.
* Per Attendee
$249
Medical Device Registration in Mexico, Brazil and Argentina
15
/ Jan
Wednesday-2020

Medical Device Registration in Mexico, Brazil and Argentina

  • Speaker: John Riggi
  • Product ID: 706292
  • Duration: 60 Min
This webinar will discuss the basics of product registration in Mexico, Brazil and Argentina such as Registration Timelines, documentation requirements and governmental processes.
* Per Attendee
$229
4-Hr Virtual Training: How to Respond to an FDA Investigation
16
/ Jan
Thursday-2020

4-Hr Virtual Training: How to Respond to an FDA Investigation

  • Speaker: Joy McElroy
  • Product ID: 704549
  • Duration: 4 hrs
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
* Per Attendee
$399
Recorded/CD
IQ, OQ, PQ - Verification and Validation for Medical Devices

IQ, OQ, PQ - Verification and Validation for Medical Devices

  • Speaker: Susanne Manz
  • Product ID: 706252
  • Duration: 90 Min
Verification and validation are important elements of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn which processes needed to be validated and what steps are required 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. A validated process is optimized ensure predictable and improved quality and compliance results.
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
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

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.
CD/Recorded
$299
Recorded/CD
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
CD/Recorded
$299
Recorded/CD
Changes in the upcoming Standard ISO 14971:2019

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.
CD/Recorded
$299
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