Data Integrity Master Class

Name: Data Integrity Master Class
Start: 2020-09-02
End: 2020-09-03
Location: Data Integrity Master Class

2-4 September 2020

Berlin, Germany

Course No 17294

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

Our Service

Costs

This conference already took place. To get a list with courses and conferences in a specific subject area according to your professional demands, please visit GMP Training Courses and Conferences by topic.

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 Ltd.
Yves Samson, Kereon AG
Dr Franz Schönfeld, GMP Inspector
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche Ltd.

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 an 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

Regulatory Update

EU GMP Requirements
- Chapter 4
- Annex 11
Guidance Documents Overview (state of the art)
- GMDP Inspectors WG, Data Integrity Q&A
- (PIC/S Good Practices for Data Management and Integrity in regulated GMP/GDP Environments)
- WHO, Annex 5 Guidance on Good Data and Record Management Practices
- MHRA GxP Data Integrity Definitions and Guidance for Industry
- FDA, Data Integrity and Compliance with cGMP
“These Guides are not intended to impose additional regulatory burden upon regulated entities”. Is This correct?
- Data Governance
- Dynamic Data

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

Data flow analysis

Objective and purpose
Electronic data flow
Complete data flow
Identification of possible weaknesses

Workshop on Data Flow Analysis

Identification of data flow weaknesses and non-compliances

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
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?

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

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

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 Persons Review

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

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

Identification of QA oversight weaknesses

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

Working in teams, the attendees will be presented with a scenario of a computerised system that generates electronic records. They will assess the record vulnerability and determine the controls to put in place to protect the records and ensure data integrity. Team outputs will be discussed with all participants.

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?

Options for Long Term Data Retention of Laboratory Data

Proprietary v open standards for laboratory data
Options for long term retention:
- Keep original system, Virtualisation, Data migration

Case study Data Migration

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
Based on a case study, attendees will be presented with key facts and determine what an organisation should do to investigate a data integrity issue. At the end of the workshop, during the discussion of the team outputs there will be a comparison with the work performed in the case study.

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