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How to Prepare for a Safety Inspection

May 6 2014 11:00AM - May 8 2014 1:00PM | Online

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Overview 

Every pharmacovigilance department will, at one time or another, undergo a governmental or health authority inspection as well as audits by vendors, partners, suppliers, internal auditors and others. The introductory online course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to conclusion of the audit.

 

Course Level: Beginner

Featured Topics 

  • How to prepare for an audit/inspection
  • How to prepare a response and corrective action plans
  • Different types of inspections and audits from around the world (EMA, UK MHRA and US FDA)
  • Review a case study

Who Should Attend 

Professionals who work in:

  • Drug Safety/Pharmacovigilance
  • Regulatory Affairs
  • Quality
  • Compliance
  • Information Technology
  • Medical Information
  • Risk Management
  • Legal
  • Pharmacology

Learning Objectives 

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

  • Define the types of inspections and audits that exist and how they differ around the world
  • Discuss the legal basis for inspections and how inspectors do their job
  • Prepare for an inspection: preparing the roadmap, team, tasks, and documents
  • Assess how to handle the actual inspection
  • Discuss how to prepare the response and CAPA

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 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 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102, (703) 506-3275.

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 .6 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 Safety and Pharmacovigilance Certificate Program: 3 Elective Units
• Regulatory Affairs Certificate Program: 3 Elective Units

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

Name Credit Type Max Credits CEU
How to Prepare for a Safety Inspection IACET 6.00 0.600

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 activity. Participants must attend the live online training activity in order to be eligible to receive a statement of credit. To request credit, complete the online 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 not available for participation in the archived sessions of the online training activity.

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

Agenda  

Day 1 Tuesday, May 06, 2014

  • 11:00AM - 1:00PM

    Part 1: Module 1: The Basics & Module 2: FDA Inspections

Day 2 Wednesday, May 07, 2014

  • 11:00AM - 1:00PM

    Part 2: Module 3: MHRA/EMA/EU Inspections; Module 4: Common Inspection Findings; Module 5: Responding to the Findings

Day 3 Thursday, May 08, 2014

  • 11:00AM - 1:00PM

    Part 3: Modules 6: What You Really Have to Do; Module 7: Behavior, Advise and Comments; Module 8: Case Studies

Registration Fees 

Other Fees

Group Site
$1750.00

Member

Charitable Nonprofit/Academia Member Individual
$350.00
Member Government Individual
$350.00
Member Standard Individual
$695.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$435.00
NonMember Government Individual
$435.00
NonMember Standard Individual
$785.00
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.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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