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Workshops - Clinical and Regulatory Training from CDG...

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Our Mission:
Our mission is to build an online university where you can learn everything there is to know about medical device clinical and regulatory issues.

The Workshop:
The Workshop is the basic unit of instruction, a 3- to 4-hour college-level training event where you focus on a specific topic related to clinical trials, regulatory affairs, biological safety, and a range of other medical device pre-approval issues. Scroll down for course descriptions.

Learning Management:
Workshops, presented live via the web, are tracked in a sophisticated Learning Management System. Your participation is recorded, you are polled for answers to case studies, you can network with each other via chat--all in real time. After the lecture you take an online quiz to reinforce your learning and a course assessment to give us your feedback.

A Learning System is an online application that tracks your participation in the whole event, including downloading and reading workshop materials, actively participating in the lecture, taking the quiz, and providing workshop assessment. It provides you with a complete transcript of your participation.

Instructor:
Workshops are taught by Nancy J Stark, PhD. Dr. Stark has over 25 years experience in device trials, serves as the US co-chair to ISO 14155—Clinical Investigation of Medical Devices for Human Subjects, is a member of ISO TC 232—Learning Services for Non-formal Education and Training, was identified as one of 100 Notable People in Medical Devices by Medical Device & Diagnostics Industry magazine, and serves on the Editorial Advisory Board of MD&DI. You can learn more about her at Nancy J Stark.

Satisfactory Completion Requirements:
CEUs are granted based on a learner’s active participation in the exercises, quiz, and assessment. An attendance of 90% of the workshop in compliance with the International Association of Continuing Education and Training standards is required. Following the IACET/ISO standards, one CEU is issued for ten contact hours.

System Requirements:
1. Personal computer.
2. Confirmed access to Adobe Connect (test connection by viewing this cartoon.)
3. Telephone with speakers.

Auditing the Workshop:
Unlike e-conferences, your participation in a workshop is monitored and recorded by a Learning Management System. Your tuition gains you the right to have a single individual log on and participate. Your colleagues may audit the workshop, but only registered learners can take the quiz and course assessment and will receive CEUs or certificates.

Certificates are Issued in the Registered Learner's Name:
We understand that your administrative assistant might purchase the registration, but please give our registration manager the name and email address of the learner who will take the course. This way, the Learning Management System can give credit to the actual learner.

  
Fee: $500 per learner
$195 per additional learner Colleagues audit free
$75 for late quiz

Agenda:
Lecture – 4 hours
Quiz – 1 hour

CEUs:
0.5 (IACET/ISO guidelines)

Quantity:

Quantity:
additional
learners

Project Management for Clinical Trials Workshop

The purpose of project management is to control the project and correct problems before they are uncorrectable. Without project management many trials evaporate into a cloud of no-enrollment and absence of data.

This is a hands-on, problem solving workshop where you’ll grapple with real-life clinical trial problems and learn practical solutions. Bring your pencil, paper, and calculator. The learning objective is to be able to apply the traditional steps of project management to clinical trials to gain control over the process. Learn more ->

Dates: Please check the calendar on CDG's home page for presentation dates.
 
Fee: $500 per learner
$195 per additional learner Colleagues audit free
$75 for late quiz

Agenda:
Lecture – 3.5 hours
Quiz – ½ hour

CEUs:
0.4 (IACET/ISO guidelines)

Quantity:

Quantity:
additional
learners

Clinical Research Quality System Workshop

FDA has suggested device companies apply the quality system regulations to clinical trials, the ICH-GCPs have always said clinical research functions should have procedures for conducting clinical trials, and now the ISO/DIS 14155 (2008) standard requires procedures and a quality system for clinical trials.

In this workshop we’ll walk through the steps of creating a quality system for clinical research, considering our customer base and work products, and examine models for the most important standard operating procedures.

The learning objective is to be able to create a clinical research quality system for your department. Learn more ->

Dates: Please check the calendar on CDG's home page for presentation dates.
 

Fee: $500 per learner
$195 per additional learner
 $75 for late quiz

Agenda:
Lecture - 4 hours
Quiz- 1 hour

CEUs:
 0.5 (IACET/ISO guidelines)  

Quantity:

Quantity:
additional
learners

Protocol Design Workshop


A good protocol begins with team consensus on what you want to claim about your device when the study is over. Writing a clear statement about efficacy or performance takes thought and debate. The difficulty is that you must commit today to what you will call a success tomorrow.

It helps to think in terms of the natural order of progression from want-to-have claims to substantiated claims.

The objective is to learn how to define the elements of a protocol to obtain a good study design. Learn more ->

Dates: Please check the calendar on CDG's home page for presentation dates.
 

Fee: $500 per learner
$195 per additional learner
 $75 for late quiz

Agenda:
Lecture - 4 hours
Quiz- .5 hour

CEUs:
 0.45 (IACET/ISO guidelines)  

May 13th

Quantity:

Quantity:
additional
learners

Adverse Event & Effect Workshop


 Adverse event reporting is one of the more difficult aspects of conducting a medical device clinical trial. The rules are different from drugs and different in the States and Europe. Even the definition of what is and isn't and adverse event can vary.

The goal of this workshop is to learn a decision-making framework that will facilitate correct adverse event recording and reporting. Learn more ->

Dates: Please check the calendar on CDG's home page for presentation dates.
 
 

Deviations and Amendments Workshop

Fee: $500 per learner
$195 per additional learner
 $75 for late quiz

Agenda:
Lecture - 3 hours
Quiz- 1 hour

CEUs:
 0.4 (IACET/ISO guidelines)  

Quantity:

Quantity:
additional
 learners

 


What, exactly, are study deviations? Deviations are incorrectly implementing the research activities as defined in the protocol, changing the configuration of the investigational device mid-study, or failing to comply with regulations.

Deviations, violations, and amendments have interesting an intercalated relationship, but no clear reporting requirements. In this workshop we'll use the FDA guidelines for study amendments to build a framework for managing and reporting deviations.

The objective is to be able to identify a deviation when it occurs and determine how to report it. Learn more ->

Dates: Please check the calendar on CDG's home page for presentation dates.
 

Regulatory Permissions Workshop

Fee: $500 per learner
$195 per additional learner
 $75 for late quiz

Agenda:
Lecture - 3 hours
Quiz- 1 hour

CEUs:
 0.4 (IACET/ISO guidelines)  

Quantity:

Quantity:
additional
learners 

 

Permission to conduct clinical trials and permission to commercialize are two of the most important approvals you'll need from FDA. In this 3-hour workshop we'll examine the roles of IDE, 510(k), and PMA submissions in the product development process.

The learning objective is to understand the differences between the three major types of FDA permissions—IDEs, 510k, and PMAs—as a basis for understanding medical device regulations. Learn more ->

Tuition: $500 for first learner; $195 for additional learners.

Dates: Please check the calendar on CDG's home page for presentation dates.
 

Fee: $500 per learner
$195 per additional learner
 $75 for late quiz

Agenda:
Lecture - 4 hours
Quiz- 1 hour

CEUs:
 0.5 (IACET/ISO guidelines)  

Quantity:

Quantity:
additional
learners

Good Monitoring Practices Workshop


Since first given responsibility to monitor the progress of their clinical trials by the regulations of 1974-76, monitoring has played a unique role in the relationship of sponsor and investigator. But it isn't magic. Monitoring is a set of skills that can be mastered by anyone with a sense of order and completeness. If you like things to be 'finished' you will make a good monitor. 

The learning objective is to be able to identify and implement the four types of monitoring visits in a clinical trial. Learn more ->

Dates: Please check the calendar on CDG's home page for presentation dates.
 
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