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Auditing Principles

3 Days
Auditing

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and requirements applicable in production and distribution of medicinal products. The course aims to provide an educational and reference tool for anyone interested in the process of auditing, and secondly, an overview and practical advice on performing audits. The main focus is put on GDP and GMP environments: distributors, warehousing, transport and repackaging site; and production of medicinal products.

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Audience

Anyone interested in auditing principles

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
Price
€ 2430

per participant    (excl. VAT)

✓ Exclusive learning approach

✓ Personal course documentation

Lunch, water, coffee & tea

Networking

✓ Course certificate after completion

Location

Quastion Learning Center (Qplus consult BVBA)

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Your Trainer

Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.

  • Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.

  • Kristina is specialized in online medical communication: webcast, webinar and e-learning.

  • She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.

  • Kristina has an extensive experience in Quality & Pharmacovigilance.

Program

Audit Definition

  • What's an audit?

Lead Auditor Responsibilities

  • Description responsibilities

  • Audit Team Member's Role

Ethical Standards, Conflict of Interest​

  • Perception

  • Conflict of interest

  • Gifts

  • Confidential Information

​​Regulatory Standards

  • Local, Europe, US

  • Federal and State Law

​Types of Audit

  • System

  • Compliance

  • Product

  • Process

​​Audit Purpose and Benefits

  • Process overview

  • Audit Program Elements

  • Benefits

​Audit Terminology

  • Frequently used terms/principles

Cultural Awareness

  • Workshop 1: Code of conduct in different countries

Audit Planning and Preparation

  • Guidance on planning and preparation

How to use Checklists as a Tool

  • Guidance on checklists

Scheduling of the Audit

  • Guidance on how to schedule an Audit​

Audit Agenda

  • What should be placed on the agenda?

  • Workshop 2: Preparing an audit agenda

​​Awareness for Detecting Fraud and Counterfeiting

  • Challenges

  • Definitions

  • Detection of Fraud

​Auditor Preparation and Selection

  • Audit Team

Opening Meeting, Audit Performance and Inspection Technique

  • Guidance on content opening meeting

  • Do's and don'ts

  • Questioning techniques

  • Collecting information

  • Workshop 3: Questioning techniques

  • How to take notes in an efficient way

​​​Audit Observation

  • How to describe observations

  • Categorization of observations

  • Workshop 4: Observations categorization

​Closing Meeting

  • Guidance on content closing meeting

  • Workshop 5: Closing meeting

​​Audit Report writing from Legal Perspective

  • Report writing

  • Workshop 6: Report writing

Corrective Action Analysis

  • Process and improvements

Supplier Risk Plans

  • How to mitigate risk

Audit Closure

  • Closure approach

Participants about this course:
Contact Quastion for more information about this Auditing Principles training.
 
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Heading 6

+32 (0) 2 899 05 68

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Leuvensesteenweg 643 bus 7

1930 Zaventem

Belgium

TAV: BE 0822 940 179

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a division of

Qplus consult BV

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