Lab Data Integrity, Part 1 - Live Online Training A Practical Approach for Generating and Auditing Laboratory Records

Lab Data Integrity, Part 1 - Live Online Training

Seminar Nr. 20722

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

All times mentioned are CET.

Kosten

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

Alle Preise zzgl. MwSt.

* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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

Zielsetzung

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.

Hintergrund

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.

Zielgruppe

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 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.

Programm

Programme Part 1
Establishing the Controls for Laboratory Data Integrity

GMP Regulations Impacting Laboratory Data and Results
  • EU GMP requirements
  • MHRA and WHO Data Integrity Guidances
  • FDA GMP requirements
  • FDA Guidance documents OOS, Inspection of QC labs
  • Inspection findings 483 and warning letters
  • Defining Data Integrity, “complete data” and „raw data“
Principles for the Generation of Data
  • Observational tests and instrument tests
  • Training of staff
  • Qualified analytical instruments and validated Software
  • Integrity issues
  • Application of ALCOA+ principles
WORKSHOP I: Generation of Data
  • What are the requirements for raw data integrity?
  • Three scenarios covering
    • a paper System
    • a hybrid system
    • a client server electronic system
Processing and Reporting of Data
  • Paper / hybrid based Systems
  • Networked systems with electronic records and signatures
  • Calculations and transformation of data manually and by computer applications
  • Application of ALCOA+ principles to the process
  • Calculating the reportable value and comparison with the specification
  • Paper processes versus electronic processes
  • Linkage with out of specification investigations (OOS)
WORKSHOP II: Processing and Reporting of Data
  • Reviewing an analytical record
  • Scenario covering paper based record and an electronic system
Reviewing Data
  • Role of the second person review
  • Determination that the reportable result is correctly calculated
WORKSHOP III: Data Review of an Excel Template

Collation and Reporting Results
  • Role of the second person Review
  • Determination that the reportable result is correctly calculated
  • Identification and correction of errors for paper and electronic systems
  • Do you have complete data?
WORKSHOP IV: Paper, Hybrid and Electronic Reporting Processes
  • Discussion of the strengths and weaknesses of reporting processes

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