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Parenteral Drug Association Connecting People, Science and Regulation ®

Mastering Challenges of Data Integrity and Computer System Validation

Oct 17 - Oct 18, 2018 |
Oct 18, 2018 |
Berlin Mariott Hotel | Berlin, 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

Instructors

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.

Wednesday, 17 October 2018

9:00
Welcome and Introduction


9:15
Regulatory Update

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

10:15
Coffee Break

10:45
“ALCOA +”

  • General requirements and principals
  • Interactive session

12:15
Lunch Break

13:15
Code of Conduct/Data Governance


13:45
Data Lifecycle / Data Integrity – Part 1

  • Presentation of a sample process

14:15
Managing Hybrid Systems

  • pH-meter, autoclave , HPLC

14:45
Coffee Break

15:15
Data Lifecycle / Data Integrity – Part 2

  • Interactive Session: Modelling the Process

17:15
End of Day 1

Thursday, 18 October 2018

9:00
Recap Day 1


9:15
Data Lifecycle / Data Integrity – Part 3

  • Interactive session: Risk evaluation, risk mitigation measures

10:45
Coffee Break

11:15
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

13:00
Lunch Break

14:00
Validation of commercial software

  • Data Migration projects
  • Part 11, Annex 11

14:30
Interactive Session

  • Risk evaluation of simple vs. complex types

15:15
Coffee Break

15:30
Audit Trail and its Review

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

16:00
Wrap-up, Q&A


16:30
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

1495 Euro

Contact

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

Exterior

Berlin Marriott Hotel
Inge-Beisheim-Platz 1
10785 Berlin
Germany
Tel: +49-30-220000
Hotel Website

Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

PDA Europe has reserved a limited number of rooms until the 14th August 2018.
Book Your Room for the PDA Group Rate

Single Room € 195 per night*
Double Room € 215 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 Charge will apply

How to Get There

Berlin-Tegel Airport – TXL
Airport Phone: +49 30 60911150
Hotel direction: 5.6 miles SE

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 60911150
Hotel direction: 12.3 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3.5 EUR hourly, 30 EUR daily

Photos

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
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4481

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