Dr. Christopher Burgess
Burgess Analytical Consultancy
Referent:innen
Dr. Bob McDowall
R.D. McDowall Ltd.
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.
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.
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.
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 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.
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?
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
Recording from 8 - 10 November 2022.
Duration of Recording: 12h 58min
| ECA-Member*: | € 2380,- |
| Regular Fee*: | € 2580,- |
| EU/GMP Inspectorates*: | € 1290,- |
| APIC Member Discount*: | € 2480,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager"
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E-Mail: info@concept-heidelberg.de
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