Data Integrity Master Class

28-30 August 2024, Copenhagen, Denmark

Course No. 21472

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Speakers

Dr. Bob McDowall

Dr. Bob McDowall

R.D. McDowall Ltd.

Yves Samson

Yves Samson

Kereon

Dr. Wolfgang Schumacher

Dr. Wolfgang Schumacher

ehemals/formerly F. Hoffmann-La Roche

Dr. Franz Schönfeld

Dr. Franz Schönfeld

Regierung von Oberfranken

Note: All times mentioned are CEST.

Objectives

  • Your will get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements
  • You will get a deeper understanding what FDA and European inspectors expects from pharmaceutical companies in regard to Data Integrity
  • You will learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System
  • You will learn how to prepare your company for a successful inspection in regard to Data Integrity
  • You will understand how to establish an effective Data Governance System
  • You will learn how to investigate Data Integrity issues in your company

Background

Even Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue 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.

Target Group

The courses are directed at
  • Managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies
  • Contract Research Organisation and Contract Manufacturing Organisation manufacturing, laboratory and QA personnel
  • Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity
Especially the Data Integrity Master Class course is directed to participants who have first experiences in Data Integrity, e.g. the ECA course “Data Integrity – Requirements for a GMP compliant Data Life Cycle".

 
For Attendees Only

Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity Guide” - Version 3

Programme

Data Integrity Master Class

Seminar Programme as PDF

Regulatory Update
  • EU GMP Requirements
    • Chapter 4, Annex 11
  • Guidance Documents Overview (state of the art)
  • “These Guides are not intended to impose additional regulatory burden upon regulated entities”. Is this correct?
    • Data Governance, Dynamic Data
Quality Culture for Data Integrity
  • Regulatory expectations for a data integrity quality culture
  • Role senior management in creating the culture
  • Components of a quality culture
  • Reinforcement of the culture
Data Flow Analysis
  • Objective and purpose
  • Electronic data flow
  • Complete data flow
  • Identification of possible weaknesses
Workshop on Data Flow Analysis

Metrics for Data Integrity
  • Metrics in the context of a corporate data integrity programme
  • Suggested metrics in the assessment phase
  • Suggested metrics in the operational phase
QA Oversight for Data Integrity
  • Data integrity training
  • Enforce data flows
  • Reviews
  • Internal inspection
  • Audit of external organisations
Workshop on QA Oversight for Data Integrity

Control of Master Templates and Blank Forms
  • Why is control of master templates and blank forms important?
  • Regulatory requirements from FDA, MHRA, WHO, EMA and PIC/S
  • Devising and controlling the master template
  • Operational use of the blank forms
  • Do you really want to work this way?
Data Integrity in the Pharmaceutical Quality System / Data Governance
  • Which PQS elements need to be added or updated?
  • The Data Integrity Program
    • Priorities (immediate/short/mid-term)
    • Capacity, Timing
  • Governance responsibilities
  • Data governance vs. IT governance
  • Elements of a data governance
  • Embedding data governance into the PQS
Audit Trail Review
  • Regulatory Overview
  • Essential Audit Trails in QA/QC/Manufacturing
  • Risk-based Approach
  • What about legacy systems w/o Audit Trail?
  • Who shall review Audit Trails? Documentation
  • What process and documentation is appropriate in case of deviations/discrepancies?
Second Person Review
  • Regulatory and guidance document requirements for the second person review
  • Role of the second person Review
  • Scope of the second Person Review
  • Documenting the review for paper, hybrid and electronic systems
  • Facilitated discussion on Second Person review
Facilitated Discussion on Second Person Review

Preparing your Company for an Data Integrity Inspection
  • How to present the DI status and future approach?
  • Gap analysis
  • Training program coverage
  • Experience from FDA inspections – Hot Buttons
DI Inspections
  • Basis for Inspections: “PIC/S Good Practices for Data Management and Integrity in regulated GMP/GDP Environments”
  • Data Integrity Assessment during Inspection
    • Quality Control, Manufacturing
  • Inspection Findings
Workshop: Data Inspection Findings

Vulnerability of Records
  • What is record vulnerability?
  • Protection and security of electronic records requirements
  • What can go wrong? Scope of misfortunes that can impact records
  • Assessment of record vulnerability and implementation of control measures
Workshop on Vulnerability of Records

Case Study Data Migration: Preserving Content and  Meaning
  • Principles of data migration
  • Design of the migration process
  • Risk-based elaboration of the verification strategy – case study examples
Cybersecurity / Cloud Computing / Time Synchronisation
  • Cybersecurity securing data integrity
  • Robust IT infrastructure
  • Time Synchronisation
  • Qualification of time dissemination
Results of a Data integrity Audit from a Contract Laboratory
  • Audit context, Audit scope, Findings, Root causes
Data Integrity Investigations
  • What are data integrity investigations?
  • Human and technical triggers for DI investigations
  • Who should investigate the problem?
  • Process description and how to document a DI Investigation
  • Should we inform regulatory authorities?
Workshop on Data Integrity Investigations

Options for Long Term Data Retention
  • Proprietary v open standards for laboratory data
  • Options for long term retention:
    • Keep original system, Virtualisation, Data migration
Workshop: Justifying Long Term Solutions

Key Learning Points and Final Discussion

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This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more

ECA-Member*: € 2090,-
Non ECA Member*: € 2290,-
EU/GMP Inspectorates*: € 1145,-
APIC Member Discount*: € 2190,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023