Data Integrity Master Class Book together with the course "Raw Data - Understanding, Defining and Managing" and save up to € 590,-

Data Integrity Master Class

Heidelberg, Germany

Course No 18799

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

 

Our Service

Costs

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

(All prices excl. VAT)

Registration
* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Bob McDowall, R.D.McDowall., UK
Yves Samson, Kereon , Switzerland
Dr Franz Schönfeld, GMP Inspector, Germany,
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche, Switzerland

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 expect 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".

Programme

Wednesday, 30 August 2023
 
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
 
Thursday, 1 September 2023
 
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
 
Friday, 2 September 2023
 
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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