Data Integrity

Description

PIC/S Data Integrity requirements and guidance from the FDA, TGA, EMA, MHRA, and more.

GMP Data Integrity Compliance Requirements (Training)

This Data Integrity training course is based on various guidance publications from regulatory authorities. It includes key Data Integrity GMP compliance examples published in the following guidance:

• PIC/s Data Integrity Guidelines (1 July 2021)
• Data Integrity/Data Governance guidance in PIC/S Annexes (including Annex 11, Computerised Systems)
• FDA’s CFRs – Data Governance/Data Integrity regulations
• The TGA’s guidelines for interpreting PIC/S Data Integrity requirements
• UK MHRA and EU EMA publications and related guidance on Data Integrity compliance requirements
• cGMP Data Integrity – common audit findings
• Other industry data integrity publications

What is covered in this Data Integrity (DI) training course?

Course topics include:

• Regulatory guidance for data integrity and data management in GMP environments
• Data governance expectations
• Data risk management/data risk assessments and prioritisation of data governance and data controls
• IT security and data protection requirements for computerised systems
• Computerised records vs paper records and the use of electronic signatures
• User authentication requirements (logins, passwords, remote access)
• Cultural/behavioural influences on data integrity compliance
• Management responsibilities for ensuring data reliability/data integrity for the data lifecycle (retention periods)
• Systems and controls for data integrity (GMP manufacturing environments)
• Pharmaceutical recordkeeping basics (ALCOA+ and Good Recordkeeping Practice or ‘GRK’) – note GRK requirements are covered in a separately available online GRK training course.
• Record changes and approval processes for corrections and mistakes
• Data integrity in the laboratory (avoiding scientific fraud)

Who should complete GMP/cGMP Data Integrity training?

This course, as part of our extensive array of online GMP training materials, is suitable for anyone who needs a better understanding of regulatory expectations for data governance and data integrity. While it focuses on data integrity in GMP environments (pharmaceutical industry data integrity, medical device industry data integrity, etc.), it is suitable for other industries as well. Data integrity regulatory compliance training (online) will suits various types of personnel, contractors, and service providers, including:

• GMP Quality Managers and Quality Associates
• Operations Managers/GMP Team Leaders
• New employees
• IT System Administrators
• Laboratory researchers
• Contractors, suppliers and distribution personnel who require introduction training (or refresher training) in data integrity compliance/regulatory expectations
• Managers and IT personnel who need to understand their cGMP data management and data governance responsibilities, including computer system access restrictions and the impact of organisational culture on data integrity (data reliability) and product quality

Note: This course can be taken as a stand-alone course or combined with other online cGMP training courses. This GMP certificate training course is available online, 24/7 from the date of purchase, for 12 months. One learner per license.

Pre-requisites

While there are no formal prerequisites for data integrity training, learners will find it helpful to first gain a basic understanding of good manufacturing practice (GMP) requirements. Learners should also complete the required good recordkeeping practice (GRP)/good documentation practice (GDocP) training courses, PIC/S Annex 11 (GMP Computerised Systems), and GXP Computerised Systems (e.g. referring to GAMP 5/2nd edition standards).

Click here to purchase GAMP5 guidance from ISPE.

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This course will also suit Regulatory Authority representatives, self-inspection personnel, and GMP Auditors who want to better understand the recent updates to GMP compliance guidelines for data integrity (DI) (e.g. from PIC/s, the FDA, the TGA, and other Regulatory Authorities)*.

 

For Quality Team leaders who need to train larger numbers of personnel on GMP compliance topics, or need multiple courses for a single user, consider the option of custom bundled training packages. 

PIC/S Data Integrity plus FDA, TGA, EMA, MHRA guidance

In addition to the latest Data Integrity guidance updates from PIC/s (the Pharmaceutical Inspection Co-operation Scheme) PE 009-16, this course includes draft guidance documents on GMP data integrity requirements from various Regulatory Authorities.

This training course includes Regulatory Authority Guidance on Data Integrity from the following sources:

• Recent PIC/s guidelines on Data Management and Data Integrity (July 2021)
• Draft documents on Data Integrity from the World Health Organisation (WHO) (June 2020)
• Data integrity GxP guidelines from the MHRA (March 2018 Draft)
• FDA Data Integrity guidelines (April 2016 Draft)
• TGA presentations and publications on Data Integrity expectations in GMP/GxP environments (2017, 2019)

Course Duration

How long will it take to complete the online training course?

• Course duration: Allow 2 to 3 hours to complete this course.
• Note: Online course completion timeframes can vary based on learning styles and pre-existing familiarity with the training topic.

Which life science industry professions require training in data integrity issues?

• Quality Managers and Responsible Person(s)
• Operations Managers
• Hospital managers/hospital personnel
• IT professionals
• GMP manufacturing personnel including contractors and maintenance workers
• GMP Team Leaders/Department Heads
• Suppliers and approved vendors (supply chain personnel, contractors, logistics personnel)
• Data Management Personnel
• Information Technology Personnel and Security System Administrators
• System Administrators, particularly IT personnel and system admin teams in GMP environments and/or laboratories
• Auditors and Self-inspection/CAPA investigators
• Department Heads
• Warehouse managers and distribution personnel
• Logistics Managers and shipping/receiving personnel
• Laboratory researchers and non-clinical personnel
• Clinical research study sponsors
• Academics and non-clinical laboratory teams/scientists/investigators
• Analysts/Laboratory Research Report Writers

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Pre-requisites: None

• Note, however, that this Introduction to Data Integrity online training course assumes learners will have an understanding of basic GMP compliance requirements.
• If learners are new to GMP environments, ensure they take “The 10 Golden Rules of GMP” and GMP Part I, GMP Part II, and product-relevant online training for PIC/s Annexes.
• Good Recordkeeping Practice (GRK) is a key requirement for compliance and while GRK is covered briefly in this online Data Integrity (cGMP/GxP requirements) training course, it requires more comprehensive training.

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Other GMP training materials (examples) 

• Good Recordkeeping Practice
• Annex 11 – Computerised Systems
• FDA CFRs 210 and 211 for pharmaceutical manufacturing 
• Good Laboratory Practice (GLP) – non-clinical 
• Preparing for an Audit (cGMP Audit checklists)
• Remote Auditing techniques/procedures training for GMP Regulators and GMP compliance Self-Inspections

Suggested reading

• Top 10 pharmaceutical industry blogs (top 10 GMP blogs)
• Pharmaceutical Industry Jobs: 5 Essential Skills
• GMP Audits and PQS deficiencies (MHRA)
• List of Global Regulatory Authorities / GMP Auditors (Who regulates GMP environments?)

Disclaimer: Education purposes only.

Successful course completion will enable the learner to get a course Certificate of Completion (dated).

*The course is based on recently updated Data Integrity (DI) compliance guidelines published by PIC/s (1 July 2021) on good data management practices and data integrity requirements; and other draft data integrity guidelines published from regulators such as the FDA (USA), the TGA (Australia), EMA (Europe), MHRA (UK) and other GMP Authorities.

 

Course Summary: Data integrity, data governance and data management responsibilities in GMP environments. Suitable for personnel, managers, contractors, system administrators and IT support personnel working in GMP environments (e.g. pharmaceutical manufacturing, medical device manufacturing, biological medicines, and ATMPs, veterinary medicines, other life science products with public health implications, etc).