Raw Data - Understanding, Defining and Managing - Online Training Recording
Course No. 21317
Speakers
Dr. Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Objectives
The aim of this online training is to understand what can be defined as raw data and to explore the meaning of the term for manufacturing, laboratory and quality records. Is there harmonisation of US and EU GMP regulations? For example:
What is a “quality decision” and what is the impact of having to define raw data for the process or system?
Can raw data be equivalent to complete information and complete data?
Should we treat manufacturing “information” and laboratory “data” as the same?
Background
FDA GMP in 21 CFR 211 requires “complete information” for manufacturing records and “complete data” for laboratory records. In contrast, Chapter 4 of EU GMP on documentation contains in the Principle three sentences that are in apparent contradiction to the United States regulations:
Records include the raw data which is used to generate other records
For electronic records regulated users should define which data are to be used as raw data
At least, all data on which quality decisions are based should be defined as raw data
In the days of harmonisation of regulations how can we reconcile these differences? This situation is compounded by the failure of EU GMP to define the term “raw data” in the regulations to help industry plan their approach to meeting these regulatory requirements.
Target Group
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
Data, Information and Knowledge An overview presentation covering for production, laboratories and QA. Link to regulations e.g,
Data vs information vs knowledge
From knowledge to insight
DIKI model
Product, Prcocess, Data
Regulations
US GMP regulations: 211.68(b), 211.180(d), 211.188 and 211.194(a-e): complete data and complete Information
EU GMP Chapter 4 regulations – raw data principles outlined from a GMP perspective
Cutting Through the Confusion and Fog of Regulatory Terms Currently there are many terms used in GMP regulations and data integrity guidance documents. What do they mean? How are they relevant to debate? Definition and interpretation of
Original record / record
Raw data – MHRA GMP and US GLP definitions
Data and metadata
True copy
Complete data
Initial data
Translating raw data for a GMP environment: should we treat manufacturing and laboratory the same when it comes to raw data?
Interpretation of Raw Data for Production Systems Using a manufacturing process that is automated by standalone PLCs, PLCs linked to a SCADA system and an automated Manufacturing Execution System, what constitutes raw data will be outlined.
Raw Data for PLCs
PLCs linked to a SCADA system
SCADA linked to a Manufacturing Execution System
Interpretation of Raw Data for Laboratory Systems Using a process involving a chromatography data system and a LIMS, what constitutes raw data will be outlined in two scenarios
Hybrid CDS and manual input to the LIMS
Electronic CDS with automatic transfer to the LIMS
Managing sample management and preparation records
Case Study/Workshop: Defining Raw Data for Production, QA and Laboratory Systems
Can a True Copy be Raw Data?
This brief presentation will start from the definitions of raw data and true copy and explore if and how a true copy can be considered raw data.
Case Study / Workshop : What are Raw Data for Quality Decisions
Recording from 29 August 2023 Duration of the recording: approx. 4 h 37 min
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more
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