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Data Integrity and Document Management Training Course
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.
10 Oct 2022
Details
Course overview
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, in- cluding 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.
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). 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.
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 including the latest 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
- Managing and preventing data integrity breaches
Presenter
Laura Brown (More...)
Dr Laura Brown MBA, BSc, PhD, is a pharmaceutical QA and training consultant and Senior Lecturer for the MSc in Clinical Research at the School of Pharmacy, University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSK, Hoechst Marion Roussel, Farmitalia and Phoenix International. Laura has a particular expertise in quality assurance including risk-based approaches to quality systems, data integrity and quality project management implementation in the pharmaceutical industry. She was Chair of the ACRPI GCP Forum for six years and regularly writes on pharmaceutical regulatory and quality issues including for the Research Quality Assurance Association’s journal.
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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10 Oct 2022 Live webinar 09:30-17:00 UK (London) |
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10 Oct 2022 Live webinar 09:30-17:00 UK (London) |
GBP 599 499 EUR 859 719 USD 970 814 Until 5 Sep* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.