Course Overview
Data integrity is currently a spotlight for regulative inspections, with each EU and federal agency inspectors more and more observant violations throughout GxP inspections.
It has become an important issue in document governance and regulators expect employees operating in GxP roles to possess been trained during this vital space.
This taciturn course covers the background to information integrity, why it's vital and the way its necessities have an effect on each paper-based and computer-based systems.
The course can embrace discussion of the most recent MHRA information integrity guide that provides steering on the info integrity expectations that ought to be thought of by organisations concerned in any
the aspect of the GxP pharmaceutical lifecycle (GCP, GMP, GLP and GvP).
You will gain associate degree understanding of the necessities for making certain information integrity, review information integrity scrutiny findings, and get practical advice on defining and implementing an appropriate data governance
process for compliance with data integrity requirements.
Benefits of attending:
Understand the importance of information integrity and smart document apply
Discuss data integrity criteria and definitions – eg ALCOA
Be aware of key regulations and guidelines
Understand QMS issues for information integrity and document management
Review document management and information integrity inspections to facilitate regulative compliance
Consider the necessities for information integrity governance to stop information integrity breaches
Who Should Attend?
This course is meant for managers and employees from all GxP area unitas within the pharmaceutical and medical device industries who are responsible for the creation, review, approval and/or reporting of
data to confirm information integrity, in particular those working in:
Clinical trials
Manufacturing
Quality assurance/quality control
Compliance
Pharmacovigilance
QA personnel from CROs/CMOs and GxP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from the programme.
Programme
Principles of data integrity and good documentation practice
What is data integrity?
Why is data integrity important?
ALCOA principles
Good documentation practice including paper and electronic records
Data integrity regulations and guidelines
MHRA/WHO/FDA/EMA/PICS/ICH GCP R2, Data Integrity guidelines
Group review and discussion of some key regulated documents together with the most recent MHRA information integrity guide
Document management and data integrity inspection findings
MHRA, EMA findings, EU non-compliance reports
FDA findings
Group discussion on inspection findings
QMS considerations for Data integrity and documentation
What area unit the weather of QMS for information integrity?
Risk management considerations
Data governance
Discussion of participants expertise and best apply for QMS and information governance
Data integrity for computer systems
Computer system validation considerations
What is expected for compliance for GXP systems
Discussion of document and data integrity issues
Data integrity and digital signatures
Certified copies/true copies
TMF
Managing and preventing data integrity breaches
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