Raw Data - Understanding, Defining and Managing - Online Training Recording

Course No. 21317

header-image

Speakers

Dr. Bob McDowall

Dr. Bob McDowall

R.D. McDowall Ltd.

Yves Samson

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

stop

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

ECA-Member*: € 990,-
Regular Fee*: € 1190,-
EU/GMP Inspectorates*: € 595,-
APIC Member Discount*: € 1090,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023