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Parenteral Drug Association Connecting People, Science and Regulation ®

Mastering Challenges of Data Integrity and Computer System Validation

Sep 05 - Sep 06, 2019 |
Sep 06, 2019 |
Sheraton Munich Arabellapark Hotel | Munich, Germany
  • Education
  • Europe
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Data Integrity is currently a hot topic in the pharmaceutical industry and in the focus of health authority inspections.

A properly validated computer system allows to establish and maintain over time the data integrity: once the regulatory requirements are met through a consistent and rigorous validation process, this implies that the required controls are in place.

This 2-day training course provides practical guidance to understand the basics of data integrity and computer system validation and offers real world learning examples of integrated approaches. A mixture of lectures and interactive sessions provides a maximum of learning success.

On the first day the focus is on regulatory foundation of data integrity, ALCOA(+) principle, data governance, modelling of data/process flows, and hybrid systems. The second day consists of workshops around risk evaluation and presentation/discussions about general principles of computer system validation and audit trail reviews.

Who Should Attend

  • Managers responsible for IT systems in pharma and
    supplier companies
  • Validation Managers
  • Laboratory Supervisors
  • Production Supervisors
  • QA Managers
  • Everybody, who is involved in the topics of Data Integrity and
    Computer System Validation

Learning Objectives

  • Acquire basics about Data Integrity and Computer System Validation
  • Apply concepts of data integrity on computer system validation
  • Gain experience through real world examples
  • Obtain knowledge to deal with the audit trail review challenge
  • Understand the ideas behind ALCOA
  • Perform computer system validation by your own


Roberto Bertini, Operations Director, PQE
A +18 years long career in Computerized Systems Validation and Data Integrity assurance. Degree in Physics at the University of “La Sapienza” in Rome, he joined PQE in 2000. He is currently Operations Director at PQE for Spain, DACH and CIS Regions, where he is leading the service delivery related to the Business Lines for Data Integrity Assurance. He has managed the validation process of most common Computerized Systems used in the Life Science environment (e.g. ERP, MES, LIMS, WMS, Lab Systems, PCS, Serialization domain) and he has supported the implementation of Quality Management Systems for the IT governance. He is currently supporting a number of pharmaceutical companies in the establishment of Data Integrity Governance and in the resulting Data Integrity Assessment and Remediation.

Stefan Godersky, Consultant, SGMP
Stefan Godersky has been active in the pharmaceutical industry since 1995 in various positions of development and production departments of Global Players for production sites in Europe and Asia. Now running his own company - he has been a consulting engineer for the medical device and pharmaceutical industry since 2010, with a focus on risk management and validation of computerised systems. Since his degree in process engineering, he has been involved in topics and projects at the interface of software development, pharmaceutical manufacturing processes and quality assurance.

Stefan Wurzer, Global Data Integrity Lead, Roche
Stefan Wurzer is Global Data Integrity Lead in Pharma Technical Operations at Roche in Basel. He is responsible for the global Data Integrity project, development and sustainment of data integrity standards and trainings, and leads a global network of Data Integrity stewards. He is working in the field of computer system validation since more than 12 years. Prior he worked for Novartis as global eCompliance Manager and as part of this role he was involved in the validation of a globally used SAP system. He holds a bachelor degree in Business Information Systems and is a frequent speaker at conferences.

Thursday, 05 September 2019

Welcome and Introduction

Regulatory Update

  • Essential Requirements / Update Guideline Changes
  • Inspection Findings / e.g. Warning Letters

Coffee Break


  • General requirements and principals
  • Interactive session

Lunch Break

Code of Conduct/Data Governance

Data Lifecycle / Data Integrity – Part 1

  • Presentation of a sample process

Managing Hybrid Systems

  • pH-meter, autoclave , HPLC

Coffee Break

Data Lifecycle / Data Integrity – Part 2

  • Interactive Session: Modelling the Process

End of Day 1

Friday, 06 September 2019

Recap Day 1

Data Lifecycle / Data Integrity – Part 3

  • Interactive session: Risk evaluation, risk mitigation measures

Coffee Break

Validation and Data Integrity

  • Principles of Computer Systems Validation
    • Software Categories
    • Validation Approaches
  • System Validation lifecycle
    • Simple vs. complex systems
  • Validation responsibilities and role of suppliers

Lunch Break

Validation of commercial software

  • Data Migration projects
  • Part 11, Annex 11

Interactive Session

  • Risk evaluation of simple vs. complex types

Coffee Break

Audit Trail and its Review

  • Requirements for Audit-Trail
  • Risk-based approach to the review of Audit Trail

Wrap-up, Q&A

End of Course

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1595 Euro


Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Sheraton Munich Arabellapark Hotel
Arabellastreet 5
81925 Munich
Hotel Website
Tel.: +49 (0)89 92320

The elegant 4-star Sheraton Munich Arabellapark Hotel offers a soundproof accommodation in a residential area of Munich. Featuring chic architecture, the hotel was renovated in 2007. The property is located in Bogenhausen district, 3.5 km from Marienplatz. The city center lies within 4 km from the venue.

A spectacular view over the countryside welcomes guests to club superior king suite, junior king suite and executive flat with modern-style décor. The property boasts views of Alps from its rooms. Room facilities also include a microwave, an electric kettle and coffee/tea makers for self-catering. The property is in a 5-minute walking distance from Richard-Strauss-Straße subway station. It will take 35 minutes to get to Franz Josef Strauss airport by car.

PDA Europe has reserved a limited number of rooms until the 15th June 2019.
Book your room for the PDA Group Rate.

Single Room € 169 per night* 
Double Room € 194 per night*

*Rates are per room and night, including the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service will apply

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66

Register Now