ComplianceOnline

Course Description:

Clinical trial management systems (CTMS) are not medical devices yet CTMS software is used to collect important clinical trial information for many products including medical devices and therefore should be validated. Available FDA guidance documents do not clearly describe how to validate a CTMS for the US market. CTMS developers, sponsors, site users and vendor/site auditors are left to interpret the clinical trial regulations and FDA guidance documents which are not directly applicable to CTMS software development.

For example, the software validation steps suggested and required for medical device software development may be appropriate for CTMS software in certain areas, but most of the medical device software requirements are not applicable to CTMS software development because the CTMS software is used for an entirely different purpose (i.e. intended use) than the medical device software. Many auditors point to the "General Principles of Software Validation" guidance and suggest rigorous medical device software validation principals which may not be the "least burdensome" path for CTMS software development. So what are the steps required for CTMS software validation and when is the CTMS software considered validated?

This course will review two FDA guidance documents related to software development in computerized systems including the "Computerized Systems Used in Clinical Investigations" which is clearly applicable to CTMS and the "General Principles of Software Validation" which is more directly applicable to software within a medical device. Attendees will understand how to use these guidance documents in a stepwise manner to create a robust CTMS software validation plan which should withstand an auditor’s scrutiny. Key features of a good CTMS software validation process will be presented and a review of the required Quality Management System and Standard Operating System documents will be discussed.


Learning Objectives:

  • Review two FDA guidance documents related to CTMS software development processes:
    • Computerized Systems Used in Clinical Investigations
    • General Principles of Software Validation
  • Understand the software validation requirements for CTMS systems
  • Develop a stepwise approach to CTMS software validation
  • Understand the key features of good CTMS software validation processes
  • Review the Quality Management System components (Standard Operating Procedures, Work Instructions and Forms) needed to support CTMS software validation


Who will Benefit:

  • Presidents and CEOs of CTMS providers
  • CTMS developers, testers auditors
  • Site Managers responsible for CTMS selection
  • Directors of Clinical and Regulatory Affairs
  • Managers of Quality Affairs
  • Clinical Research Coordinators & Associates
  • Clinical Project Managers, Research Nurses, Scientists and Others



Course Outline:

Day One     Day Two
  • Introductions - 15 Min
    • Instructor
    • Participants
  • Session 1: Session 1:  Overview of Validation - 30 Min
    • Definition of validation
    • Differences between CTMS and Medical Device Software
  • Session 2: Computerized Systems Used in Clinical Investigations - 60 Min
    • Requirements
    • Safeguards
    • System features
    • Personnel training
  • Break - 30 Min
  • Workshop: Developing a checklist from the guidance of required activities and features - 60 Min
  • Lunch - 60 Min
  • Session 3: General Principles of Software Validation - 60 Min
    • Verification
    • Validation documents
    • Software Development Life Cycle
  • Workshop: Developing a checklist from the guidance of required activities and features - 60 Min
  • Break - 30 Min
  • Interactive Session 4 (Facilitated Group Discussion): Software validation requirements for CTMS systems - 75 Min
    • What applies from the guidances
    • What doesn’t apply and why

   
  • Day 1 Recap - 15 Min
  • Session 5: Stepwise approach to CTMS software validation - 60 Min
    • Approach
    • Gap Analysis
    • Action Plans
  • Case Study: Gap Analysis and Action Plan - 60 Min
  • Break - 30 Min
  • Session 6: Quality Management System tools - 30 Min
    • SOPs and Work Instructions
    • Checklists
  • Q&A and Conclusions - 45 Min




Meet Your Instructor

Dr Joy Frestedt
President and CEO of Frestedt Incorporated

Dr. Frestedt is President and CEO of Frestedt Incorporated, a virtual Contract Research Organization including a corporate network of over 70 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of experience in the health care, pharmaceutical, medical device and food-related industries assisting firms with strategic decisions involving clinical trials, successful regulatory negotiations and the development of quality management systems to compete globally. She has held key positions at Johnson and Johnson's Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical providing leadership and management for the development of pharmaceutical, medical device and food products.

Dr. Frestedt holds a BA in biology from Knox College and a PhD in pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, Society of Clinical Research Associates, Association of Clinical Research Professionals (where she served as past chapter president and on the Editorial Advisory Board), and she is a Fellow and past chair of the ethics committee for the Regulatory Affairs Professionals Society. Dr. Frestedt recently founded Alimentix, the Minnesota Diet Research Center, was named interim Regulatory Director for the University of Minnesota Academic Health Center and she is one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE, 2011 as well as one of the top 25 “Industry Leaders” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal, 2011.




Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($150) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.







Local Attractions

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.




The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.




A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.




City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.




San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity




We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading