LEARNING OBJECTIVES:

� Validation – Validation strategies – What needs to be validated? – Process oriented vs. transaction oriented – Global versus local – Best practice approach – Agile vs. V-Model

� Operation – Change management – Lifecycle management – Periodic evaluation – Data Migration

� Audit trail in SAP

� Data Integrity and SAP

� SAP S/4 HANA in a GxP environment

6-7 November 2018, Berlin, Germany

WA/27122017This education course is recognised for the ECA GMP Certification Programme „Certified Computer Validation Manager“. Please find details at www.gmp-certification.eu

� Live demonstration: Using SAP Solution Manager as a Validation platform

� Get a set of useful templates for download � SAP S/4 HANA

SAP – Validation and GMP Compliance

SPEAKERS:

Thomas BrandacherPWC Consulting

Lasse JanzDräger

Florian RauchDHC Dr. Herterich and Consultants

Stefan StaubDHC Dr. Herterich and Consultants

Stefan TempsDHC Dr. Herterich and Consultants

Objectives

You will learn � How to validate SAP in a GMP environment � Which specific requirements should be taken into

consideration in the CSV process � How to use SAP Solution Manager as a validation

platform � What problems could arise during validation and how

to solve them � How to maintain the validated state of SAP with the

least efforts

Background

The leading Enterprise Resource Planning (ERP) System in industry is SAP. Meanwhile it has also become the stand-ard solution for pharmaceutical companies.

As the system is used for GMP critical operations (e.g. inventory, master data management, batch release) valida-tion is a must and a critical element of the SAP implemen-tation.

Controlled operations, including Change Control will ensure the validated state is maintained.

This ECA course will offer you shared best practices for the validation of SAP considering recent regulatory requirements like EU GMP Guide Annex 11, GAMP® 5 and 21 CFR Part 11.

Target Group

This Education Course is directed at experienced employees from

� IT & IT Service Providers � Quality Assurance / Quality Control � Production / Engineering

who have to deal with SAP in a healthcare environment.

Templates

All participants get a set of useful templates for download

� Validation plan � User requirement specifications � Functional specifications � Test scripts � Risk assessment questions � SOPs for operating the validated system � Data migration

Programme

Introduction SAP Validation � Legal requirements � Process oriented vs. transaction oriented validation � Best practice approach � Agile vs. V-Model

SAP Configuration Management vs. Validation Approach

� Implementation Approach � Customizing and Developments � Change and Transport System � Enhancement Packages and Business Functions

System landscape of SAP � Pharma process landscape � What is needed and what needs to be validated

(high level risk assessment) � Introducing the SAP modules � Standard risk assessment for each module

Live demo

Using SAP Solution Manager as a Validation platform � Project Tool in a regulated environment

– Document management – Test management – Document status report

� Support Tool – Incident management – Integrative change management

Special features of SAP HANA � SAP S/4 Hana innovation highlights � Transformation scenarios to SAP S/4 HANA � Challenges for the validation approach � Validation of S/4 HANA as cloud deployment

Process harmonisation and standardisation using a template strategy / SAP and GMP Compliance

� Functional gaps � Process driven system functionality � Compliance driven system functionality

Managing a global SAP program in a validated environment

� Governance and global framework � Vendor selection & staffing (including offshoring) � Ramp up and training � Documentation approach � Milestones & key deliverables � Toll gate reviews � Data migration approach � SOX in a project � Handover to support � Including templates and selected guidelines.

SAP – Validation and GMP Compliance

6-7 November 2018, Berlin, Germany

Data Migration � A strategic approach to data migration � Regulatory requirements and data migration � Validating the data migration

Data Integrity and SAP � Regulatory requirements (FDA, EU, MHRA) � Critical processes (QC) � Roles and responsibilities � SAP support tools (MDG)

Audit trail in SAP � Compliance for audit trails: definitions and

requirements � A risk-based approach to audit trails � Implementing audit trails � Audit trail reviews

Processes and experiences with validation of SAP within a regulatory context

� Change management; IT Validation and electronic record keeping for quality relevant process software as a manufacturer of medical devices

� How to ensure that quality relevant impacts are evaluated when changing a validated SAP system?

� How to ensure that efforts for validation are kept on an efficient level without compromising quality and regulatory requirements?

� How to effectively link system, process and validation documentation?

� How to manage electronic records within SAP?

GMP compliance for SAP authorisation � User and authorisation management � Documentation approach for authorisation � Testing of authorisation requirements

Social Event

In the evening of the first course day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.

Speakers

Thomas Brandacher PWC Consulting LLC, Tokyo, JapanThomas Brandacher was Head Global ERP Project Management Office (PMO) at the Sandoz site in Holzkirchen close to Munich.

Within Sandoz and other companies he managed SAP projects over a period of more than 10 years. He joined PWC Consulting as Managing Director in 2016.

Lasse Janz Drägerwerk AG & Co. KGaA, GermanyLasse Janz studied Business Informatics at Kiel University of Applied Science. Since 2015 he is a Quality Manager at Drägerwerk AG & Co.

KGaA (Software Validation Officer, Global Process Owner Software Validation and Global Process Owner Electronic Signature).

Florian Rauch DHC Dr. Herterich & Consultants GmbH, GermanyFlorian Rauch joined DHC Dr. Herterich & Consultants as a Consultant in 2013. During

the last years he worked in multiple SAP Solution Man-ager implementation and SAP authorization projects in medical devices industry. Florian studied Computer Science at the University of Applied Sciences in Schmal-kalden (Germany).

Stefan StaubDHC Dr. Herterich & Consultants AG, SwitzerlandStefan Staub joined DHC Dr. Herterich & Consultants AG as a Consultant in 2006. He is

a specialist in Computerized System Validation with a strong focus on large SAP ERP implementation projects. Since 2012 he is part of the DHC AG management team. Prior joining DHC AG Stefan studied Business Adminis-tration with an emphasis on Information and Technology Management at the University of St. Gallen (Switzerland).

Stefan TempsDHC Dr. Herterich & Consultants AG, SwitzerlandStefan Temps joined DHC Dr. Herterich & Consultants as a Senior Consultant in 1996.

Since 2000 he is Managing Director of DHC AG, Switzer-land. During the last years he was engaged as project manager for SAP ERP implementation projects and GxP compliance in the pharmaceutical industry. Prior to joining DHC in 1996, Stefan studied Industrial Engineer-ing and Management at the Technical University of Hamburg (Germany).

Rese

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4 Easy Registration

Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 Heidelberg, Germany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

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

#

Date

Tuesday, 6 November 2018, 09.00 h – 18.00 h(Registration and coffee 08.30 h – 09.00 h)Wednesday, 7 November 2018, 08.30 h – 17.00 h

Venue

Steigenberger Hotel BerlinLos-Angeles-Platz 110789 Berlin, GermanyPhone +49(0)30 2127 0berlin@steigenberger.de

Fees (per delegate plus VAT)

ECA 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 documentation, dinner on the first day, lunch on both days and all re-freshments. VAT is reclaimable.

Accommodation

CONCEPT HEIDELBERG has reserved a limited num-ber of rooms in the conference hotels. You will re-ceive a room reservation form when you have regis-tered for the event. Reservation should be made directly with the hotel. Early reservation is recom-mended.

Would you like to save money?

If you book “SAP – Validation and GMP Compliance and “Virtual IT Systems in a GxP Environment” (8-9 November 2018) simultaneously the fee reduces as follows:ECA Members € 2,790APIC Members € 2,890Non-ECA Members € 2,990EU GMP Inspectorates € 1,690

Conference Language

The official conference language will be English.

Organisation and Contact

ECA has entrusted Concept Heidelberg with the organisation of this event. CONCEPT HEIDELBERG, P.O. Box 10 17 6469007 Heidelberg, GermanyPhone +49-(0)62 21/84 44-0Fax +49-(0)62 21/84 44 84info@concept-heidelberg.de www.concept-heidelberg.de

For questions regarding content:Dr Andreas Mangel (Operations Director) at +49(0) 62 21 / 84 44 41 or at mangel@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.:Mr Rouwen Schopka (Organisation Manager) at +49(0) 62 21 / 84 44 13 or per e-mail at schopka@concept-heidelberg.de.

WA/27122017Gen

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#

LEARNING OBJECTIVES:

� Advantages and disadvantages of virtual systems in a GxP environment

� Benefits of virtualisation � Regulations apply to virtualisation � Differences between virtual systems and real systems � What are the critical points - during implementation - during qualification and - during operation of virtual systems

� Virtualisation platform � Planning and qualification of a virtualisation project � Case studies from virtualisation projects � Change management / configuration management and disaster recovery

� From virtualisation to cloud computing

8-9 November 2018, Berlin, Germany

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

Virtual IT Systems in a GxP Environment

SPEAKERS:

Bob McDowallR.D.McDowall Limited

Yves SamsonKereon AG

Jürgen SchmitzGSK

Objectives

� Get an overview of technologies discussed currently in the pharmaceutical environment and their poten-tial fields of application,

� Assess how to use and implement GMP requirements and provisions for virtual IT systems and, where appropriate, for cloud computing,

� Learn more about the qualification and use of virtual systems in the GMP environment, and

� Evaluate whether the use of virtual IT systems and cloud computing would be profitable if your com-pany.

Background

Virtual systems, cloud computing, and GMP; does this fit together? What are the advantages and disadvantages of these systems in a GMP environment? Are there any limits with their use?

The increasing use of virtual IT systems and cloud computing in a GMP-regulated environ-ment is getting more and more discussed. The vir-tualisation of computer systems offers a great

number of advantages, such as the simultaneous use of multiple operating systems, the simple and low-cost con-struction of test environments, and the improved utilisa-tion of multi-core processors.

Can these advantages also be used in a GMP environment and which aspects have to be specifically considered from the “GMP view” for virtual systems and cloud computing?

This event considers virtual systems and cloud computing from the GMP point of view and provides practical support to determine measures regarding the use of such systems.

Target Audience

The event is aimed at managers in the pharmaceutical in-dustry, suppliers and service providers that operate virtual IT systems and cloud computing in a GMP environment or intend to use them in the future.

Programme

Principles of IT qualification and validation � Regulatory requirements � Definitions � Validation and qualification

What is Virtualisation? � Definitions � Physical platform foundation requirements � Software for virtualisation � Virtual platform options

Benefits of Virtualisation � On demand infrastructure � Speed of implementation � Flexibility

Regulations apply to Virtualisation � Annex 11 key points for consideration � IT infrastructure shall be qualified � In-house or hosted system

Qualification of IT-Infrastructure � General Principles of IT Infrastructure Qualification � How to do qualification in a real environment vs.

what to do in a virtual environment � Qualification Activities � Roles and responsibilities � Installation and Testing

Planning of virtualisation projects � User / Technical Requirements Specification � Definition of the installation and deployment

approach � Definition of backup cycles and scenarios � From a virtual server to a virtual farm � Efficient planning � Qualification planning

Compliance requirements for virtual systems � IT Infrastructure Platform � Server Platform Qualification � Virtual Platform considerations � Maintaining the Qualified State during operation

Overview of the virtualisation platform � Platform components � Platform operation � Handling of SANs and VMs

Qualification of the virtualisation platform � Requirements gathering � Platform design � Qualification planning � Supporting processes

Virtual IT Systems in a GxP Environment

8-9 November 2018, Berlin, Germany

Making of a virtual data centre � Specification of virtual data centre requirements � Do I qualify or validate the hypervisor software? � Building and qualifying a virtual data centre

Risk management � ASTM E 2500-07 � Good Engineering Practice (GEP) � Q 9 – Quality risk management � GAMP 5, M 3 � GEP, Qualification, Validation reconciliation � NIST-SP 800-30 Risk Management for IT systems � HA-Op

Virtualisation of laboratory equipment / Desktop virtualisation

� Use cases for virtualisation in a laboratory environment

� Operating a virtual system

Show and tell: Virtualisation documentation � Technical Requirements Specification � Configuration Specifications � Installation Qualification

Change & Configuration Management � Regulatory requirements � What is a change? � Definitions of change management & configuration

management � An outline change management process

Disaster recovery planning � Regulatory requirements for Disaster Recovery � Disaster Recovery or Business Continuity Planning? � Mitigating physical faults � Triggers for the plan � Testing the plan � Keeping the plan up to date

Workshop: Risk-based approach to planning of virtualisation platform The participants should assess and control the risks related to the virtualisation of some critical systems, such as DMS, CDS, ERP, LIMS, process historian

From virtualisation to Cloud Computing � What is Cloud Computing really? � Abstraction of services and IT-infrastructure � Virtualisation vs. Cloud Computing � Recommendations for a GxP compliant Cloud

Computing

Speakers

Dr Bob McDowallR.D.McDowall Limited, Bromley, Kent, UKAnalytical chemist with over 40 years experience including 15 years working in the pharmaceutical industry and af-terwards working for the industry as a consultant. Bob is an ISO 17025 asses-sor and he has been involved with the

validation of computerised systems for over 25 years and is the author of a book on the validation of chromatogra-phy data systems. He was also a contributor to the GAMP GPG IT Infrastructure control & compliance.

Yves SamsonKereon AG, Basel, SwitzerlandYves is founder of Kereon AG, Basel. He is member of GAMP Europe Steer-ing Committees, chairman and co-founder of GAMP Francophone and edited the French version of GAMP 4 and GAMP 5. In 2017, Yves launched

the e-Compliance Requirements Initiative (eCRI) with the aim to help the regulated pharmaceutical industry and its suppliers to address and to implement accurately, con-sistently, and effectively the regulatory e-Compliance re-quirements.

Dr Jürgen SchmitzGSK, Wavre, BelgiumJürgen Schmitz was from 1994 until 2000 at RELAB AG and from 2000 - 2003 at KPMG Consulting AG responsi-ble for computer systems validation. Between 2003 and 2015 he was in dif-ferent positions at global IT Quality

Management at Novartis and Novartis Vaccines and Di-agnostics. Since 2016 he is Head Quality IT and Compli-ance at GSK Vaccines.

Social Event

In the evening of the first course day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.

Rese

rvat

ion

Form

(Ple

ase

com

ple

te in

full)

F

Vir

tual

IT S

yste

ms

in a

GxP

En

viro

nm

ent,

8-9

No

vem

ber

20

18, B

erlin

, Ger

man

y F

SAP

– V

alid

atio

n a

nd

GM

P C

om

plia

nce

, 6-7

No

vem

ber

20

18, B

erlin

, Ger

man

y

*

Mr

*

Ms

Title

, firs

t nam

e, s

urna

me

Co

mp

any

Dep

artm

ent

Imp

ort

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Ple

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C

ON

CEP

T H

EID

ELBE

RG

P.O

. Box

1017

64

Fax

+49

(0) 6

2 21

/84

44 3

4

D

-690

07

Hei

del

ber

g

GER

MA

NY

+

49

6221

84

44 3

4 Easy Registration

Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 Heidelberg, Germany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

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

Date

Thursday, 8 November 2018, 09.00 h – 17.30 h(Registration and coffee 08.30 h – 09.00 h)Friday, 9 November 2018, 08.30 h – 16.30 h

Venue

Steigenberger Hotel BerlinLos-Angeles-Platz 110789 Berlin, GermanyPhone 030 2127 0berlin@steigenberger.de

Fees (per delegate plus VAT)

ECA 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 documentation, dinner on the first day, lunch on both days and all re-freshments. VAT is reclaimable.

Accommodation

CONCEPT HEIDELBERG has reserved a limited num-ber of rooms in the conference hotels. You will re-ceive a room reservation form when you have regis-tered for the event. Reservation should be made directly with the hotel. Early reservation is recom-mended.

Would you like to save money?

If you book “Virtual IT Systems in a GxP Environment” and “SAP – Validation and GMP Compliance” (6-7 November 2018) simultaneously the fee reduces as follows:ECA Members € 2,790APIC Members € 2,890Non-ECA Members € 2,990EU GMP Inspectorates € 1,690

Conference Language

The official conference language will be English.

Organisation and Contact

ECA has entrusted Concept Heidelberg with the organisation of this event. CONCEPT HEIDELBERG, P.O. Box 10 17 6469007 Heidelberg, GermanyPhone +49(0) 62 21/84 44-0Fax +49(0) 62 21/84 44 84info@concept-heidelberg.dewww.concept-heidelberg.de

For questions regarding content:Dr Andreas Mangel (Operations Director) at +49(0) 62 21 / 84 44 41 or at mangel@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.:Mr Rouwen Schopka (Organisation Manager) at +49(0) 62 21 / 84 44 13 or per e-mail at schopka@concept-heidelberg.de.

WA/11122017Gen

eral

term

s an

d c

ond

itio

nsIf

you

cann

ot a

ttend

the

conf

eren

ce y

ou h

ave

two

optio

ns:

1. W

e ar

e ha

ppy

to w

elco

me

a su

bst

itute

col

leag

ue a

t any

tim

e.2.

If y

ou h

ave

to c

ance

l ent

irely

we

mus

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rge

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fol-

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cess

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fees

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cella

tion

- un

til 2

wee

ks p

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ence

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can

cel a

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If th

e ev

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mus

t be

canc

elle

d, r

egis

tran

ts w

ill b

e no

tified

as

soon

as

poss

ible

and

w

ill re

ceiv

e a

full

refu

nd o

f fee

s p

aid

. CO

NC

EPT

HEI

DEL

BERG

will

not

b

e re

spon

sib

le fo

r dis

coun

t airf

are

pena

lties

or o

ther

cos

ts in

curr

ed

due

to a

can

cella

tion.

Te

rms

of p

aym

ent:

Pay

able

with

out d

educ

-tio

ns w

ithin

10 d

ays

afte

r rec

eip

t of i

nvoi

ce.

Imp

ort

ant:

Thi

s is

a b

ind

ing

regi

stra

tion

and

ab

ove

fees

are

due

in

case

of c

ance

llatio

n or

non

-ap

pea

ranc

e. If

you

can

not t

ake

part

,

you

have

to in

form

us

in w

ritin

g. T

he c

ance

llatio

n fe

e w

ill th

en b

e ca

lcul

ated

acc

ord

ing

to th

e po

int o

f tim

e at

whi

ch w

e re

ceiv

e yo

ur

mes

sage

. In

case

you

do

not a

ppea

r at t

he e

vent

with

out h

avin

g in

form

ed u

s, y

ou w

ill h

ave

to p

ay th

e fu

ll re

gist

ratio

n fe

e, e

ven

if yo

u ha

ve n

ot m

ade

the

paym

ent y

et. O

nly

afte

r we

have

rece

ived

yo

ur p

aym

ent,

you

are

entit

led

to p

artic

ipat

e in

the

conf

eren

ce

(rec

eipt

of p

aym

ent w

ill n

ot b

e co

nfirm

ed)!

(As

of Ja

nuar

y 20

12)

Ger

man

law

sha

ll ap

ply.

Cou

rt o

f jur

isd

ictio

n is

Hei

del

ber

g.

Priv

acy

Polic

y: B

y re

gist

erin

g fo

r thi

s ev

ent,

I acc

ept t

he p

roce

ssin

g of

my

Pers

onal

Dat

a. C

once

pt H

eid

elb

erg

will

use

my

dat

a fo

r the

pr

oces

sing

of t

his

ord

er, f

or w

hich

I he

reb

y d

ecla

re to

agr

ee th

at m

y pe

rson

al d

ata

is s

tore

d a

nd p

roce

ssed

. Con

cept

Hei

del

ber

g w

ill o

nly

send

me

info

rmat

ion

in re

latio

n w

ith th

is o

rder

or s

imila

r one

s. M

y pe

rson

al d

ata

will

not

be

dis

clos

ed to

third

par

ties

(see

als

o th

e pr

ivac

y po

licy

at h

ttp:/

/ww

w.g

mp-

com

plia

nce.

org/

eca_

priv

acy.

htm

l).

I not

e th

at I

can

ask

for t

he m

odifi

catio

n, c

orre

ctio

n or

del

etio

n of

my

dat

a at

any

tim

e vi

a th

e co

ntac

t for

m o

n th

is w

ebsi

te.

#