DUBLIN–(BUSINESS WIRE)–The “Data
Integrity and Document Management for GxP Compliance”
conference has been added to ResearchAndMarkets.com’s
offering.
Data Integrity is a critical issue in document governance. It
increasingly becoming a focus for regulatory inspections globally. This
course will equip you with knowledge necessary to identify and avoid
potential Data Integrity issues before auditors do.
Course Overview
Data integrity is now a focus for regulatory inspections, with both EU
and FDA inspectors increasingly observing violations during GxP
inspections. It has become a critical issue in document governance and
regulators expect staff working in GxP roles to have been trained in
this important area.
This concise course covers the background to data integrity, why it is
important and how its requirements affect both paper-based and
computer-based systems. The course will include discussion of the
recently finalised MHRA data integrity guide which provides guidance on
the data integrity expectations that should be considered by
organisations involved in any aspect of the GxP pharmaceutical lifecycle
(GCP, GMP, GLP and GvP). You will gain an understanding of the
requirements for ensuring data integrity, review data integrity
inspection 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 data integrity and good document practice
- Discuss data integrity criteria and definitions – eg ALCOA
- Be aware of key regulations and guidelines
-
Understand QMS considerations for data integrity and document
management -
Review document management and data integrity inspections to
facilitate regulatory compliance -
Consider the requirements for data integrity governance to prevent
data integrity breaches
Who Should Attend:
This course is designed for managers and staff from all GxP areas in the
pharmaceutical and medical device industries who are responsible for the
creation, review, approval and/or reporting of data to ensure data
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.
Agenda:
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 including
the new MHRA data 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 are the elements of QMS for data integrity?
- Risk management considerations
- Data governance
-
Discussion of participants experience and best practice for QMS and
data 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
Final questions and summary discussion
For more information about this conference visit https://www.researchandmarkets.com/r/blywal
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Information
Management, Pharmaceutical
Manufacturing
