Lab Data Integrity - Meeting FDA & EU Concerns - Part 1

Lab Data Integrity - Meeting FDA & EU Concerns - Part 1

Prague, Czech Republic

Course No 17593


Costs

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

(All prices excl. VAT)

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

These two courses have the following objectives:

Part 1:
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.

Part 2:
The auditing course will develop the understanding of what is required for a data integrity audit of a laboratory computerized system and then develop the principles, based mainly on workshops and discussions, of how to audit hybrid and electronic laboratory systems. The scope of auditing a system for data integrity will be developed during the course 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. At the end, attendees will read the laboratory audit report, determine if there are any findings and classify them. Then feed back selected audit findings to the quality control manager and head of quality assurance.

A checklist will be provided to all attendees for the auditing of computerised systems for data integrity.

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. In April 2016 a draft Data Integrity guidance was issued for industry comment.
In March 2015, also MHRA issued an updated Data Integrity Guidance containing an expansion of the expectations of Data Integrity governance together with a list of 19 definitions and expectations for each one. Followed in July 2016 by a more general guidance for GXP data integrity.

In June 2016, the World Health Organisation issued a final version of a guidance document which provides a more encompassing explanation of Data Integrity and also data governance expectations for regulated healthcare companies. EMA and PIC/S both issued draft Data Integrity guidance documents in August 2016. ECA have published two versions of Data Governance and Data Integrity guidance in 2016 and 2018. The GAMP Forum has  published a Guide on Records and Data Integrity in 2017 and the first of three Good Practice Guides on Data Integrity - Key Concepts. Lastly, PDA has also issued a guidance document for pharmaceutical laboratories in August 2018.

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. This is reflected in the way the two courses will be presented.

Part 1 focuses on three types of record that can be found in analytical laboratories working to GMP: paper, hybrid computerized system and electronic workflows with electronic signatures. Through presentations, work- shops and discussions attendees are taken through the process from analysis to generation of results to under- stand Data Integrity issues.

Part 2 takes the principles from the earlier course and develops them to enable attendees to be able to conduct effective internal audits or self-inspections of either hybrid or electronic systems in compliance with EU GMP Chapter 9. This is achieved mainly via a series of interlinked workshops with a few presentations. This course will focus only on hybrid and electronic Systems.

Target Group

These courses will be of significant value to:
  • Managers and scientists from Quality Control and Analytical Development Laboratories wanting to understand the Data Integrity and auditing 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

Programme

Part 1: Establishing the Controls for Ensuring Laboratory Data Integrity

EU and FDA 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
  •  Identification and correction of errors for paper and electronic systems
  •  Do you have complete data?
WORKSHOP III: Data Review – Paper Records
  • Application of ALCOA+ principles for the review of paper records
WORKSHOP IV: Facilitated Discussion
Paper, Hybrid and Electronic Reporting Processes
  •  Discussion of the strengths and weaknesses of reporting processes

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