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ECA - Data Integrity

 

Data Integrity (24/25 March 2020)

Objective

  • You will get a deeper understanding what European  inspectors expect from pharmaceutical companies in regard to Data Integrity and how they deal with Data Integrity issues during inspections
  • You will learn how to prepare your company for a successful inspection in regard to Data Integrity
  • You will learn how to investigate Data Integrity issues  in your company, especially in manufacturing and engineering
  • You will discuss suppliers’ responsibilities in Data Integrity compliance

Background

Even Data Integrity has been one of the basic GMP principles for years, multiple Data Integrity citations have been reported by FDA und European inspectors during the last five years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections.

As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA - published (draft) documents to describe the regulatory expectations of Data Integrity.

Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily business and how to integrate suppliers’ experience.

Moderator

Yves Samson, ECA Data Integrity & IT Compliance Interest Group

Target Audience

  • Managers and staff from Manufacturing, QA and Engineering of pharmaceutical companies and suppliers
  • Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity

 

Programme (24 March 2020)

CONGRESS KEYNOTE

Annex 1 Revision – the long and winding road
Dr. Bernd Renger, Immediate Past Chair, European Qualified Person AssociationThe drivers of change

  • New paradigms and concepts
  • Contamination Control und Quality Risk Management
  • Stakeholder consultation
  • New expectations to Media Fills and Lyophilisation
  • The big challenges – CCIT and PUPSIT

 

Data Integrity from an Inspector's Point of View
Maria Kladi, National Organization for Medicines, Greece

  • Data integrity and Good Documentation Practice
  • Principles of Data Integrity
  • WHO/FDA/MHRA Data Integrity Guidances
  • Examples of Data Integrity issues

Data Integrity by Design
Stefan Schoettle, Roche Diagnostics

  • Systems, Processes, Organizations
  • Data Lifecycle based measures
  • Best practice (dos and don'ts)
  • Challenges today
  • Available and emerging technologies

DI as topic of GMP-inspections; an inspectors view
Dr. Arno Terhechte, Bezirksregierung Münster

  • Specific documents requested during preparation of an inspection
  • How DI is addressed in the Quality Management resp. Data Governance system
  • What is the company-specific definition of data (GxP-Data)?
  • Specific activities during implementation / operation of compu-terized GxP systems (risk management, validation approach, backup, archiving, rolls and responsibilities)
  • Data Flow in manufacturing and quality control
  • Ensuring Compliance with regard to DI at service provider and contract manufacturers / labs
  • Inspection findings

Case Study: A risk based approach for systematic DI-assessments and -mitigation  
Hannah Greiner, Fresenius Kabi Austria

  • How to get started with DI gap assessments
  • How to set up a systematic DI assessment approach
  • How to document DI assessments
  • How to identify high risk DI gaps that need immediate mitigation
  • How to define a risk-based mitigation strategy
  • Experiences with this risk based approach during a CS inspection by Austrian Authorities (AGES)

Requirements for Operating Computerized Systems and Data Management
Dr. Philip Hörsch, Vetter Pharma Fertigung

  • Data Integrity: Definitions and requirements for operating compu-terized systems
  • Risk-based evaluation of data management (data input and output during operation) and follow-up activities for application (e.g. data review)
  • Application of data management evaluation in case of new system acquisition and for assessment of existing systems
  • Examples from quality control and manufacturing (aseptic, secondary packaging)

Data Integrity Compliance Improvement: A Combined Approach to Mitigation
Matthias Runge / Dirk Denecke, Bayer

  • Challenges of a gap-based approach to ensure data integrity for a large number of computerized systems
  • Ensuring data integrity with a general set of mitigation measures
  • General mitigation measures combined with gap-based approach
  • Practical experiences

 

Programme (25 March 2020)

CONGRESS KEYNOTE

Case Study AbbVie: The new Biologics Site in Singapore
Dr. Rolf Ratke, Abbvie
Ronan Mc Garvey, Abbvie Singapore

  • The Site strategy
  • Products, processes & equipment
  • Cooperation with EMA, blueprint to prepare for the successful pre-approval-inspection
  • From start- up to realization until approval

Data Integrity implementation at Curium
Dr. Ruud van Stigt, Curium

  • Intro Curium, the Nuclear Medicine company
  • Direct Cause for follow up the program
  • Why are we doing this
  • Remediation plan
  • What is next, where are we standing

Practical applications of Data Integrity and Audit Trail Review
Sinéad Cowman, Lonza

With the intro of the Data Integrity guidelines and the focus on the data management and security, the audit trail has become a primary focus of inspections. Understanding your Audit trail and the ability to review the data contained in it is now essential to compliance.

  • Recommendations in understanding the audit trail functionality and approaches for validation.
  • Importance of details of user requirements and user acceptance testing of audit trail functionality
  • Review of the audit trail: System review vs Data review & Event logs vs. audit logs
  • Identify and avoid typical pitfalls

Practical Examples found and case studies on how to challenge DI potential issues
Swa Vandeweyer, Formerly Janssen Pharmaceutica

  • Introduction and real life examples
  • Practical challenges on potential DI issues in Production, Calibration, Quality Organisation

Data Integrity in the interaction between business departments and IT as service provider
Thomas Wibbeling, Miltenyi Biotec

  • Aspects of Data Integrity and their translation into "tangible" requirements
  • Data Integrity and its implementation in SLAs between business units and IT
  • IT strategy as a provider of shared services for the regulated environment

Data integrity from engineering to operations based on Comos DDMS at Boehringer Ingelheim
Günther Kurta, Boehringer Ingelheim

  • How to validate a complex engineering tool landscape according to EU GMP Annex 11 and 15
  • Change management (working layer technique)
  • Assisted engineering document and data management (e.g. object-oriented engineering templates, IEC document classification, flexible unique tags)
  • Approval workflows and electronic signature (CFR 21 Part 11)
  • Electronic plant documentation (incl. fulltext search, redlining)
  • Plant maintenance interface
  • Future scenarios (brownfield enablement, scanning solution, intelligent P&ID

Data Integrity and Process Validation: a virtuous circle
Yves Samson, ECA Data Integrity & IT Compliance Interest Group

  • How much data are needed?
  • Understanding the process
  • Reporting validation
  • Securing data integrity