SAP Validation and

GMP Compliance
Live demonstration: Using SAP Solution
Manager as a Validation platform
Get a set of useful templates for download
SAP HANA

SPEAKERS:

Thomas Brandacher
PWC Consulting

Lasse Janz
Drger

Florian Rauch
DHC Dr. Herterich and
Consultants

14-15 November 2017, Copenhagen, Denmark

Stefan Staub
DHC Dr. Herterich and
Consultants LEARNING OBJECTIVES:

Validation
Validation strategies
What needs to be validated?
Stefan Temps Process oriented vs. transaction oriented
DHC Dr. Herterich and Global versus local
Consultants Best practice approach
Agile vs. V-Model

Operation
Change management
Lifecycle management
Periodic evaluation
Data Migration

Audit trail in SAP

Data Integrity and SAP

This education course is recognised for the ECA GMP Certification Programme Certified Computer Validation Manager.
Please find details at www.gmp-certification.eu
SAP Validation and GMP Compliance
14-15 November 2017, Copenhagen, Denmark

Objectives Programme

You will learn Introduction SAP Validation

How to validate SAP in a GMP environment Legal requirements
Which specific requirements should be taken into Process oriented vs. transaction oriented validation
consideration in the CSV process Best practice approach
How to use SAP Solution Manager as a validation Agile vs. V-Model
platform
What problems could arise during validation and how SAP Configuration Management vs. Validation
to solve them Approach
How to maintain the validated state of SAP with the Implementation Approach
least efforts Customizing and Developments
Change and Transport System
Enhancement Packages and Business Functions
Background
System landscape of SAP
The leading Enterprise Resource Planning (ERP) System in What is needed and what needs to be validated (high
industry is SAP. Meanwhile it has also become the stand- level risk assessment)
ard solution for pharmaceutical companies. Introducing the SAP modules
Standard risk assessment for each module
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- Live demo
tation.
Using SAP Solution Manager as a Validation platform
Controlled operations, including Change Control will Project Tool in a regulated environment
ensure the validated state is maintained. Document management
Test management
This ECA course will offer you shared best practices for Document status report
the validation of SAP considering recent regulatory Support Tool
requirements like EU GMP Guide Annex 11, GAMP 5 and Incident management
21 CFR Part 11. Integrative change management

Target Group Special features of SAP HANA

Big Data in the regulated environment
This Education Course is directed at experienced Differences between conventional and the in memory
employees from database
IT & IT Service Providers What will be new in S/4 HANA Datamigration from
Quality Assurance / Quality Control old Systems
Production / Engineering Validation efforts fort he cloud solution
who have to deal with SAP in a healthcare environment.
Pharma process landscape
IT systems and pharma processes
Templates Special features of pharmaceutical processes
Processes, IT systems and GxP compliance
All participants get a set of useful templates for
download Process harmonisation and standardisation using
Validation plan a template strategy / SAP and GMP Compliance
User requirement specifications Functional gaps
Functional specifications Process driven system functionality
Test scripts Compliance driven system functionality
Risk assessment questions
SOPs for operating the validated system
Data migration
Managing a global SAP program in a validated Speakers
environment
Governance and global framework Thomas Brandacher
Vendor selection & staffing (including offshoring) PWC Consulting LLC, Tokyo, Japan
Ramp up and training Thomas Brandacher was Head Global ERP
Documentation approach Project Management Office (PMO) at the
Milestones & key deliverables Sandoz site in Holzkirchen close to Munich.
Toll gate reviews Within Sandoz and other companies he managed SAP
Data migration approach projects over a period of more than 10 years. He joined
SOX in a project PWC Consulting as Managing Director in 2016.
Handover to support
Including templates and selected guidelines. Lasse Janz
Drgerwerk AG & Co. KGaA, Germany
Data Migration Lasse Janz studied Business Informatics at Kiel
A strategic approach to data migration University of Applied Science. Since 2015 he
Regulatory requirements and data migration is a Quality Manager at Drgerwerk AG & Co.
Validating the data migration KGaA (Software Validation Officer, Global Process
Owner Software Validation and Global Process Owner
Data Integrity and SAP Electronic Signature).
Regulatory requirements (FDA, EU, MHRA)
Critical processes (QC) Florian Rauch
Roles and responsibilities DHC Dr. Herterich & Consultants GmbH,
SAP support tools (MDG) Germany
Florian Rauch joined DHC Dr. Herterich &
Processes and experiences with validation of SAP Consultants as a Consultant in 2013. During
within a regulatory context the last years he worked in multiple SAP Solution Man-
Change management; IT Validation and electronic ager implementation and SAP authorization projects in
record keeping for quality relevant process software medical devices industry. Florian studied Computer
as a manufacturer of medical devices Science at the University of Applied Sciences in Schmal-
How to ensure that quality relevant impacts are kalden (Germany).
evaluated when changing a validated SAP system?
How to ensure that efforts for validation are kept on Stefan Staub
an efficient level without compromising quality and DHC Dr. Herterich & Consultants AG,
regulatory requirements? Switzerland
How to effectively link system, process and validation Stefan Staub joined DHC Dr. Herterich &
documentation? Consultants AG as a Consultant in 2006. He is
How to manage electronic records within SAP? a specialist in Computerized System Validation with a
strong focus on large SAP ERP implementation projects.
Audit trail in SAP Since 2012 he is part of the DHC AG management team.
Compliance for audit trails: definitions and Prior joining DHC AG Stefan studied Business Adminis-
requirements tration with an emphasis on Information and Technology
A risk-based approach to audit trails Management at the University of St. Gallen (Switzerland).
Implementing audit trails
Audit trail reviews Stefan Temps
DHC Dr. Herterich & Consultants AG,
GMP compliance for SAP authorisation Switzerland
User and authorisation management Stefan Temps joined DHC Dr. Herterich &
Documentation approach for authorisation Consultants as a Senior Consultant in 1996.
Testing of authorisation requirements Since 2000 he is Managing Director of DHC AG, Switzer-
land. During the last years he was engaged as project
Social Event manager for SAP ERP implementation projects and GxP
compliance in the pharmaceutical industry. Prior to
In the evening of the first joining DHC in 1996, Stefan studied Industrial Engineer-
course day, you are cordially ing and Management at the Technical University of
invited to a social event. This is
an excellent opportunity to Hamburg (Germany).
share your experiences with
colleagues from other
companies in a relaxed
atmosphere.
 If the bill-to-address deviates from the specifications Reservation Form (Please complete in full) + 49 6221 84 44 34
on the right, please fill out here:
FF SAP Validation and GMP Compliance, 14-15 November 2017, Copenhagen, Denmark
FF Virtual IT Systems in a GxP Environment, 16-17 November 2017, Copenhagen, Denmark

* Mr * Ms
Reservation
Easy Registration

Title, first name, surname

P.O. Box 10 17 64
Form:

Company Department
CONCEPT HEIDELBERG

Important: Please indicate your companys VAT ID Number P.O. Number (if applicable)
69007 Heidelberg, Germany

CONCEPT HEIDELBERG Street/P.O. Box

P.O. Box 101764

Fax +49 (0) 62 21/84 44 34 City Zip Code Country

D-69007 Heidelberg Phone/Fax

GERMANY

E-Mail (please fill in)

Reservation Form:
+ 49 6221 84 44 34

General terms and conditions structors, or speakers without notice or to cancel an event. If the event you have to inform us in writing. The cancellation fee will then be Privacy Policy: By registering for this event, I accept the processing
If you cannot attend the conference you have two options: must be cancelled, registrants will be notified as soon as possible and calculated according to the point of time at which we receive your of my Personal Data. Concept Heidelberg will use my data for the
1. We are happy to welcome a substitute colleague at any time. will receive a full refund of fees paid. CONCEPT HEIDELBERG will not message. In case you do not appear at the event without having processing of this order, for which I hereby declare to agree that my
2. If you have to cancel entirely we must charge the fol- be responsible for discount airfare penalties or other costs incurred informed us, you will have to pay the full registration fee, even if personal data is stored and processed. Concept Heidelberg will only
lowing processing fees: Cancellation due to a cancellation. you have not made the payment yet. Only after we have received send me information in relation with this order or similar ones. My
- until 2 weeks prior to the conference 10 %, Terms of payment: Payable without deduc- your payment, you are entitled to participate in the conference personal data will not be disclosed to third parties (see also the privacy
- until 1 weeks prior to the conference 50 % tions within 10 days after receipt of invoice. (receipt of payment will not be confirmed)! (As of January 2012) policy at http://www.gmp-compliance.org/eca_privacy.html).
- within 1 week prior to the conference 100 %. Important: This is a binding registration and above fees are due in German law shall apply. Court of jurisdiction is Heidelberg. I note that I can ask for the modification, correction or deletion of my
CONCEPT HEIDELBERG reserves the right to change the materials, in- case of cancellation or non-appearance. If you cannot take part, data at any time via the contact form on this website.
@ e-mail:

#
Fax
Date

Venue

follows:
mended.

organisation etc.:
Accommodation
Hammerichsgade 1

ECA Members 1,490

Conference Language
ECA Members 2,790
APIC Members 1,590
+45 3342 6100

APIC Members 2,890

Phone +45 3342 6000
Radisson Blu Royal Hotel

organisation of this event.

Fax +49-(0)62 21/84 44 84

Organisation and Contact
Non-ECA Members 1,690

Non-ECA Members 2,990

Phone +49-(0)62 21/84 44-0

Fees (per delegate plus VAT)

EU GMP Inspectorates 845

www.concept-heidelberg.de
69007 Heidelberg, Germany

info@concept-heidelberg.de
1611 Copenhagen V, Denmark

at +49(0) 62 21 / 84 44 41 or at
EU GMP Inspectorates 1,690
freshments. VAT is reclaimable.

Would you like to save money?

For questions regarding content:

mangel@concept-heidelberg.de.

schopka@concept-heidelberg.de.
Internet:

For questions regarding reservation, hotel,

at +49(0) 62 21 / 84 44 13 or per e-mail at

Dr Andreas Mangel (Operations Director)
CONCEPT HEIDELBERG, P.O. Box 10 17 64
(Registration and coffee 08.30 h 09.00 h)

Mr Rouwen Schopka (Organisation Manager)

Tuesday, 14 November 2017, 09.00 h 18.00 h

The official conference language will be English.

ECA has entrusted Concept Heidelberg with the

tered for the event. Reservation should be made
Wednesday, 15 November 2017, 08.30 h 16.30 h

directly with the hotel. Early reservation is recom-

ber of rooms in the conference hotels. You will re-
email royal.meetings.events@radissonblu.com

November 2017) simultaneously the fee reduces as

ceive a room reservation form when you have regis-

and Virtual IT Systems in a GxP Environment (16-17

If you book SAP Validation and GMP Compliance
of invoice and includes conference documentation,

CONCEPT HEIDELBERG has reserved a limited num-

dinner on the first day, lunch on both days and all re-
The conference fee is payable in advance after receipt
info@concept-heidelberg.de www.gmp-compliance.org

WA/11112016