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Designed for Success: Utilizing Protocol Quality by Design (QbD) to Plan Clinical Studies

May 1 2014 11:00AM - May 1 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


Essential information and practical skills are needed to build a strong foundation for identifying and managing risks to quality in the protocol development process. Quality by Design (QbD) emphasizes building quality into the process from the beginning to help avoid risks from becoming realized. The Critical to Quality (CTQ) parameters also need to be identified. This webinar will outline what aspects of a trial have a meaningful impact on patient safety and interpretation of trial results, including:

  • What proactive steps can be taken to avoid risks/problems inherent in running a clinical study
  • Identification of critical to quality factors in protocol design
  • What ongoing checks can be performed to detect problems
  • How will the impact of any corrective actions be assessed   

Who Should Attend 

Professionals involved in:

  • Clinical Development
  • Clinical Operations
  • Science
  • Academia
  • Medical Monitoring
  • Medical Writing
  • Regulatory Affairs
  • BioMetrics
  • Quality Assurance
  • Quality Management
  • Risk Management in support of Clinical and Device Trials

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Discuss the regulatory expectations for applying Protocol Quality by Design
  • Describe  the concepts of Quality by Design (QbD) including protocol design, trial operations, monitoring, and quality improvement
  • Define “errors that matter” in other words the Critical to Quality (CTQ) parameters in clinical trial design and execution
  • Determine priorities for addressing CTQ parameters
  • Discuss how Quality by Design can be implemented within your organization

Contact Information 

Printable Registration Form

Registration Questions and Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Karen Tenaglia, CE Manager
Phone +1.215.442.6196
Fax +1.215.442.6199
Karen.Tenaglia@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Presenter(s) 

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Continuing Education 

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 1 Elective Unit
• Project Management Certificate Program: 1 Elective Unit
• Regulatory Affairs Certificate Program: 1 Elective Unit

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Designed for Success: Utilizing Protocol QbD IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Thursday, May 15, 2014.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for participation in the archived version of the webinar.

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Member Academia Individual
$175.00
Member Standard Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Standard Individual
$350.00
Registration Information

Printable Registration Form

  • Individual registration is a license for ONE internet login allowing one viewer.
  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities:  Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs

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