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Strategies for Good Clinical Practice Audits

Sep 23 2014 12:00PM - Oct 2 2014 1:30PM | Online

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Overview 

This online training will be broadcast in Eastern Time (ET)


Learn basic knowledge of Good Clinical Practice audit programs and strategies.  This online course is designed to help you with types of audits and inspections, audit reporting, general procedures in preparing for a FDA inspection, role and findings of FDA inspections and how to successfully handle and respond to a FDA inspection.

Course Level: Beginner

Who Should Attend 

  • Clinical research associates
  • Quality assurance auditors
  • Data management professionals
  • Medical writers
  • Regulatory affairs professionals

Learning Objectives 

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

  • Describe the quality assurance audit process
  • Strategically plan, prepare for and organize a GCP inspection
  • Recognize the various type of audit programs and strategies
  • Manage the GCP audit process and how to ensure a successful outcome
  • Handle and successfully respond to FDA inspection findings

Special Offers 

Register More than One Group Site and Save 15%!

Contact Information 

Registration Questions and
Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details and Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Faculty 

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Continuing Education 

Corexcel is accredited as a provider of continuing nursing education by American Nurses Credentialing Center’s Commission on Accreditation.

Corexcel designates this activity for a maximum of 7.5 contact hours.

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 .8 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.

This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 4 Core Units
• Regulatory Affairs Certificate Program: 4 Elective Units

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

Name Credit Type Max Credits CEU
Strategies for Good Clinical Practice Audits IACET 7.50 0.800
Strategies for Good Clinical Practice Audits RN 7.50 0.000

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:

Continuing education credits are available to learners who participate in the live online training course. To request credit, complete the on-line credit request process through My Transcript at www.diahome.org. 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 two weeks after the last day of the activity.

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

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE

Agenda  

Day 1 Tuesday, Sep 23, 2014

  • 12:00PM - 1:30PM

    Part 1: Audit Programs and Strategies & The Role of the Audit

Day 2 Wednesday, Sep 24, 2014

  • 12:00PM - 1:30PM

    Part 2: Preparation of the Audit & The Audit Report

Day 3 Tuesday, Sep 30, 2014

  • 12:00PM - 1:30PM

    Part 3: Preparing for an FDA Audit

Day 4 Wednesday, Oct 01, 2014

  • 12:00PM - 1:30PM

    Part 4: FDA Audit Follow-up

Day 5 Thursday, Oct 02, 2014

  • 12:00PM - 1:30PM

    Part 5: FDA Audits and Findings

Registration Fees 

Other Fees

Group Site
$2750.00

Member

Charitable Nonprofit/Academia Member Individual
$550.00
Member Government Individual
$550.00
Member Standard Individual
$1095.00

Non-Member

Charitable Nonprofit/Academia Nonmembe Individual
$635.00
NonMember Government Individual
$635.00
NonMember Standard Individual
$1185.00
Group Discounts

GROUP SITE:
Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.

*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.

This online training offering is sold as one complete series and cannot be purchased in parts.


Cancellation Policy: No refunds will be provided in the event of a participant’s cancellation since all costs for this online training course 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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