DUBLIN–(BUSINESS WIRE)–The “Data Integrity and Document Management Training Course” conference has been added to ResearchAndMarkets.com’s offering.
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 programme will include discussion of the latest MHRA data integrity guide and EMA TMF guideline that should be considered by organisations involved in any aspect of the GxP pharmaceutical lifecycle (GCP, GMP, GLP and GvP).
Document management and data integrity are a key focus of 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.
Ensuring data integrity is an important component of the pharma industry’s responsibility to guarantee the safety, efficacy, and quality of drugs. Violations relating to document management and data integrity have led to numerous regulatory actions, including warning letters and critical inspection findings. To address these concerns, the FDA, EMA, MHRA and the World Health Organization (WHO) have all recently published data integrity guidelines.
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
Ensure you are compliant with the new EU trial master file (TMF) guideline
Be aware of key regulations and guidelines
Discuss QMS considerations for data integrity and document management
Review document management and data integrity inspections to facilitate regulatory compliance
Consider the requirements for document management and 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.
Key Topics Covered:
Principles of data integrity and good documentation practice
What is data integrity?
Why is data integrity important?
ALCOAprinciples
Good documentation practice including paper and electronic records
Data integrity regulations and guidelines
MHRA/WHO/FDA/EMA/PICS/ICHGCPR2 data integrity guidelines
Group review and discussion of some key regulated documents including the latestMHRAdata integrity guide
Document management and data integrity inspection findings
MHRA,EMAfindings, EU non-compliance reports
FDAfindings
Group discussion on inspection findings
QMS considerations for Data integrity and documentation
What are the elements ofQMSfor data integrity?
Risk management considerations
Data governance
Discussion of participant’s 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
Managing and preventing data integrity breaches
Speakers
Laura Brown
Pharmaceutical QA and Training Consultant
University of Cardiff
Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International.
She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
For more information about this conference visit https://www.researchandmarkets.com/r/ak95uu