Data Integrity Master Class - Online Training Recording
Course No. 21318
Speakers
Dr. Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Dr. Wolfgang Schumacher
ehemals/formerly F. Hoffmann-La Roche
Dr. Franz Schönfeld
Regierung von Oberfranken
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 online training is 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".
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
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
Case Study/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
Case Study/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
Case Study/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
Case Study/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?
Case Study/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
Case Study/Workshop: Justifying Long Term Solutions
Recording from 30 August 2023 Duration of the recording: approx. 15 h 38 min
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more
Testimonials