This education course is recognised for the ECA GMP Certification Programme „GDP Compliance Manager“. Please find details at www.gmp-certification.eu

LEARNING OBJECTIVES:

� Regulatory Requirements and Expectations

� Audit Management (from Preparation to Follow-Up)

� Typical Audit Findings

� Conducting a GAP Analysis

� Quality Oversight

� Communication in an Audit

SPEAKERS:

Mag. pharm. Andreas KraßniggAustrian Agency for Health and Food Safety (AGES)

Dr Martin MelzerChemgineering Business Design GmbH

Anil RattuRoche

Wolfgang SchmittConcept Heidelberg

20-21 November 2018, Vienna, Austria

The GDP Audit

How to conduct and pass GDP Audits and Inspections

All participants will receive: � the current GDP-Guidelines as

a handy Paperback � an SOP on Self-Inspection � a Checklist for GDP-Compliance

Supported by theEuropean GDP Association

Learning Objectives

The EU GDP Guidelines have been extensively revised to take into account the changing nature of the glo-balised supply chain. One important aspect is auditing partners in the supply chain. But who needs to audit which service provider and how? And who will be inspected by the authorities? And how can I prepare myself?

In this training course you will learn � How to plan and conduct audits efficiently � How to prepare yourself when being audited � How to face the various challenges � What communication techniques are needed � How you can avoid and solve conflicts

Background

The revised GDP Guidelines highlight the need for an effective quality management system and appropriate controls for all partners and service providers in the distribution chain (like manufacturers, wholesalers, warehouses and transport and logistics providers).

Qualification of these partners, like for example with au-dits, is a core element to implement the GDP require-ments.

Initial and continuous professional training for auditors is of utmost importance as the authorities expect highly qualified personal performing audits. Therefore, the ECA has developed the programme at hand to give you a de-tailed overview about important matters to consider and to discuss important tasks and challenges of GDP audits.

On the other hand you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome.

Target Audience

This education course is designed for all managers, supervisors and other staff members who are involved in audits of pharmaceutical storage, transportation, cold chain and distribution activities.

Moderator

Wolfgang Schmitt

Programme

Regulatory Part:

Overview: Regulatory Requirements and Guidance � EU-GMP Guidelines � EU-GDP Guidelines � Other Guides � Who needs to audit? � Expectations of the Authorities

Regulatory Inspections and typical GDP Deviations � GDP inspections

- Who will be inspected- Different kinds of inspections- Approach- Classification of audit findings

� Examples of frequent observations and typical audit findings:- Storage- Transport- Wholesalers

Audit Management Part:

Part 1: Planning the Audit � Evaluation of the distribution chain/ Risk-based

planning � Audit planning and resource planning � Auditor training and qualification

Part 2: Conducting the Audit � Aide Memoire vs. Checklist (benefits and risks) � Audit strategy during the audit � Audit report and classification of findings

Part 3: Audit Follow-Up � Follow-up of corrective/ preventive actions (CAPA) � Development of Key Quality Performance Indicators

(KQPI) � CAPA efficiency evaluation in the follow-up audit

All participants will receive

- the current GDP-Guidelines as a handy Paperback- an SOP on Self-Inspection- a Checklist for GDP-Compliance

The GDP Audit

20-21 November 2018, Vienna, Austria

Practical Part:

GDP Certification to Quality Oversight beyond the Audit

� Preparation for the GDP audit � Auditing and qualifying service providers: a look

behind the scenes - what can go wrong � Deviation management � Beyond GDP - Staying ahead of the game for IVD/

MDs Product Quality specifics

The Psychology of Audits � The challenge of appropriate communication in an

audit � When things go wrong: conflict management

Workshop: Before being audited: Conducting a GAP Analysis

� Preliminary considerations – what are the require-ments? What are the expectations?

� Conducting your own GAP Analysis � Action plan & processing � How to keep the achieved status

Social Event

In the evening of the frist course day, you are cordially invited to a social event (city tour and dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmos-phere.

Speakers

Mag. pharm. Andreas KraßniggAustrian Agency for Health and Food Safety (AGES)Mag.pharm. Andreas Kraßnigg is Head of Inspections at the Austrian Agency for Health and Food Safety (AGES) and the Austrian Federal Office for Safety in Health Care (BASG).

Dr Martin MelzerChemgineering Business Design GmbH, GermanyDr Martin Melzer is Senior Consultant GMP Compliance. Before that he was GMP Inspector in a German Field Inspec-torate in Hannover. During that time he was representing the German inspector-ates in EMA and PIC/S Working Groups for the preparation of the new GDP-Guidelines.

Anil RattuRoche Diagnostics Ltd, U.K.Anil Rattu is Quality Manager, Global Distribution Quality. He leads and en-sures GPD compliance of Roche’s Sup-ply Chain network of hubs, local sales affiliate warehouses and 3PL partners.

Wolfgang SchmittConcept Heidelberg, GermanyWolfgang Schmitt is Director Operations at Concept Heidelberg. Before that he was Associate Director, Qualified Person and Lead Auditor at Abbott.

The European GDP Association

The European GDP Association aims to support Pharmaceuti-cal Industry, Authorities and Logistic Providers with regard to

the implementation of Good Distribution Practice.

It represents all stakeholders e.g. from Pharmaceutical Industry, Authorities and Logistic Providers and supports all members and stakeholders by providing them information

and support in the implementation of GDP.

The Association is a not for profit organisation under the umbrella of the ECA Foundation. Membership is fee to all

individuals involved in Good Distribution Practice (currently more than 2.000 members).

www.good-distribution-practice-group.org

Rese

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Date

Tuesday, 20 November 2018, 9.30h – 17.30h(Registration and coffee 9.00h – 9.30h)Wednesday, 21 November 2018, 9.00h – 13.30h

Venue

Radisson Blu Park Royal Palace Hotel ViennaSchlossallee 81140 Vienna, AustriaPhone +43/1/89110 9 200 Fax +43/1/891 109 050

Fees (per delegate plus VAT)

ECA Members € 1,490European GDP Association Members € 1,490APIC Members € 1,590Non-ECA Members € 1,690EU GMP Inspectorates € 845The conference fee is payable in advance after receipt of invoice and includes conference docu-mentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.

Accommodation

CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.

Registration

Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.

Conference language

The official conference language will be English.

Organisation and Contact

ECA has entrusted Concept Heidelberg with the organisation of this event.

CONCEPT HEIDELBERGP.O. Box 10 17 64D-69007 Heidelberg, GermanyPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 34E-mail: info@concept-heidelberg.dewww.concept-heidelberg.de

For questions regarding content:Mr Wolfgang Schmitt (Operations Director) at +49(0) 62 21 / 84 44 39, or per e-mail at w.schmitt@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.:Ms Nicole Bach (Organisation Manager) at +49(0) 62 21 / 84 44 22, or per e-mail at bach@concept-heidelberg.de.

WA/29012018

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info@concept-heidelberg.de Internet:www.gmp-compliance.org

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