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Safety Audits and Inspections

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Overview 

This module is part of the DIA Drug Safety eLearning Program. The Safety Audits and Inspections module provides an introduction to audits and inspections as part of pharmacovigilance. The module provides information about audits and inspections, with specific focus on the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) inspections. The module also discusses common inspection findings, how companies should respond to an inspection, and practicalities of inspections and audits.

Featured Topics 

  • Types and Scope of Audits and Inspections
  • Common Inspection Findings
  • Responding to an Inspection
  • Corrective and Preventive Action Plan

Who Should Attend 

Professionals working in the area of:

  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Postmarketing activities
  • Regulatory affairs
  • Medical affairs
  • Quality assurance/compliance
  • Anyone who would like to enhance their knowledge and understanding of drug safety

Learning Objectives 

Upon completion of this course, participants should be able to:

  • Define audits and inspections, different types, and their scope
  • Describe FDA inspections and possible sanctions
  • Describe European Medicines Agency (EMA) and MHRA inspections, the legal basis for European inspections, the new European guideline on pharmacovigilance inspections, the MHRA’s risk-based approach, and possible sanctions
  • Discuss inspection findings common to both FDA and MHRA, and to each agency individually
  • Describe how a company should respond to an FDA inspection, including the Corrective and Preventive Action Plan (CAPA)
  • Explain the “practicalities” of inspections and audits – what a company needs do

Special Offers 

Save 20% by purchasing all six modules in Drug Safety eLearning Program for $1,920 (a $480 savings).  Save 10% on the purchase of two to five modules.

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 3.25 contact hours or .325 CEUs. 0286-0000-14-416-H04-P Type of Activity: Application


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 .3 CEUs for this program.

This eLearning module is part of DIA’s Certificate Program and is awarded the following: • Clinical Safety and Pharmacovigilance Certificate Program: 2 Elective Units
If you successfully complete all six modules in the Drug Safety eLearning Program, the Elective Units will be converted into the required Core Units in the Clinical Safety and Pharmacovigilance Certificate Program. For more information go to www.diahome.org/certificateprograms

Release Date: October 27, 2014
Expiration Date: October 27, 2017*

*Continuing education credit is available to participants who successfully complete the eLearning program before the expiration date.

Name Credit Type Max Credits CEU
Safety Audits and Inspections ACPE 3.25 0.325
Safety Audits and Inspections IACET 3.25 0.300

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:

In order to receive a statement of credit (before the one year purchase expiration date and before the expiration date listed above), please review the entire module, complete the exam and evaluation form. You must receive a passing score of 80% or better to receive a statement of credit. A statement of credit will be emailed within one month of receipt of exam and evaluation form. Please note: If you do not complete the module, pass the module exam, AND complete the evaluation form, you will not receive a statement of credit.

Registration Fees 

Other Fees

Individual
$400.00
Group Discounts

Save 20% by purchasing all six modules in Drug Safety eLearning Program for $1,920 (a $480 savings).  Save 10% on the purchase of two to five modules.

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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