Lab Data Integrity, Part 2 - Live Online Training A Practical Approach for Generating and Auditing Laboratory Records

Lab Data Integrity, Part 2 - Live Online Training

Course No 20549

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

All times mentioned are CET.

Costs

ECA-Member*: EUR 1290,--
Non ECA Member*: EUR 1490,--
EU/GMP Inspectorates*: EUR 745,--
APIC Member Discount*: EUR 1390,--

(All prices excl. VAT)

* 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

Dr Christopher Burgess, Chairman of the ECA Analytical Quality Control Working Group
Dr Bob McDowall, Member of the ECA IT Compliance Interest Group

Objectives

The learning objectives are firstly, understand the data integrity requirements of a GMP regulated laboratory in Pharmaceutical organisations and contract labs and secondly, how laboratory personnel can ensure compliance and be able to defend their positions. Records generated by three processes will be taken through the presentations and workshops: paper only with records maintained in a laboratory notebook or controlled sheets, hybrid system with signed paper records with underlying electronic records and an electronic system using electronic signatures. Second person review is a critical process that needs to be thorough and effective to ensure that data issues are picked up and resolved.

The auditing part of the Live Online Training will develop the understanding of what is required for a data integrity on-site or remote audit of a laboratory computerized system and then develop the principles, based mainly on workshops and Q&A session, of how to audit hybrid and electronic laboratory systems. The scope of auditing (on-site and remote) a system for data integrity will be developed during the training along with a risk based prioritisation of the key areas to focus audit attention on. In preparation for the final sessions there will be workshops dealing with specific data integrity topics.

Background

Data Integrity is currently the major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies globally. The regulatory concern has been responded by the FDA issuing Compliance Program Guide (CPG) 7346.832 that covers Pre-Approval Inspections. This document became effective in May 2012 after Agency inspectors received training in Data Integrity where they focus on computer systems and not the paper output. The CPG objective 3 covers the laboratory data integrity Audit.

Since 2015, various regulatory authorities have published data integrity guidance documents e.g.
  • MHRA: 2 versions of a GMP guidance in 2015 and a GXP guidance in 2018
  • WHO: two guidance documents in 2016 and 2021.  The 2016 version is more comprehensive and contains the best description of ALCOA criteria in any regulatory guidance.
  • FDA: issued an interpretation of cGMP about data integrity in a Q&A format and
  • PIC/S: published their final version of PI-041 guidance in 2021.
Industry bodies have also been active with the GAMP Forum publishing a Records and Data Integrity Guide in 2017 and three Good Practice Guides.  APIC and PDA have issued guidance documents on the subject.

Finally, ECA have issued a Data Governance and Data Integrity Guide that delegates will get a free electronic copy of.
The emphasis of all regulators is on the ALCOA principles to outline regulatory expectations for ways to ensure the integrity of data over the life cycle.

The Live Online Training focuses on three types of records that can be found in analytical laboratories working to GMP: paper, hybrid computerized system and electronic workflows with electronic signatures. Through presentations, workshops and Q&A sessions attendees are taken through the process from analysis to generation of results to understand Data Integrity issues.

Target Group

This Live Online Training will be of significant value to:
  •  Managers and scientists from Quality Control and Analytical Development Laboratories wanting to understand the Data Integrity and audit process
  •  Quality Assurance personnel
  •  Contract Research Organisation and Contract Manufacturing Organisation laboratory and QA personnel
  •  Auditors (internal and external) responsible for assessing laboratory quality and Data Integrity

Technical Requirements

We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Programme Part 2
Self Inspections and Audits to confirm Effective Data Integrity Controls
 
WORKSHOP IV: Paper, Hybrid and Electronic Reporting Processes
  • Discussion of the strengths and weaknesses of reporting processes
Data Integrity Self Inspections and On-site and Remote Audits for Hybrid and Electronic Systems
  •  Observations and findings
  •  Remote audits: practicalities, limitations and problems
WORKSHOP V: Electronic Signature Auditing
  • Use of electronic signatures can mask some Data Integrity issues
  • Can the attendees find what those issues are?
  • Feedback from the teaching team
WORKSHOP VI: Risk Assessment and Prioritisation
  • So much to do but so little time – risk management in practice
  • When conducting a Data Integrity audit which areas within a pharmaceutical quality system will be the focus?
  • Feedback from the teaching team
WORKSHOP VII: Audit of an Excel Spreadsheet
  • Attendees will be given an example of a spreadsheet
  • What questions need to be asked to determine if there is sufficient Data Integrity and control?
  • Feedback from the teaching team
WORKSHOP VIII: Auditing a Hybrid Standalone System
  • A laboratory system is used in hybrid mode
  • What questions should the auditor ask to determine if there are any data integrity problems?
  • Feedback and discussion with the teaching team
WORKSHOP IX: Auditing a Networked Laboratory System – Audit Trail Review
  • Review of audit trail entries is a key data integrity requirement of Annex 11
  • Attendees will review the printout of an audit trail to determine if there any data integrity issues to be raised?
  • Can the attendees find what those issues are?
  • Feedback and discussion with the teaching team
WORKSHOP X: Preparing for the Data Integrity Audit
  • Preparation for a remote audit - what can you read?
  • Requesting the Site Master File
  • Requesting documents
  • Handling time zone differences
  • What video conferencing system will you use?
WORKSHOP XI: Conducting a Remote Data Integrity Audit
  • Remote laboratory tour - what are you allowed to see?
  • On-line access to networked computer Systems
  • Access to standalone systems?
  • Viewing documents on-line
  • Screens for the remote audit and taking notes
WORKSHOP XII: Reviewing the Follow up Responses from a Remote Data Integrity Audit
  • Access to documents after the Audit
  • Reviewing responses to audit findings
  • Resolution of audit findings with evidence
Review of the Course and Key Learning Points

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