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Lead Auditor

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 becoming an GMP/GDP auditor. You will receive an overview and practical advice on performing audits. The main focus is put on auditing of GMP and GDP environments: distributors, warehousing, transport and repackaging site; and production of medicinal products.

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Audience

Anyone involved in auditing activities

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
10:00 - 10:30
Networking & closing
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 04.jpg

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.

Kristina Bindus Small.jpg

    Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
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:
Date

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Lead Auditor

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Quastion Learning Center

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

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