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.
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
- 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
- MHRA, EMA findings, EU non-compliance reports
- FDA findings
- Group discussion on inspection findings
- 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
- Computer system validation considerations
- What is expected for compliance for GxP systems?
- Data integrity and digital signatures
- Certified copies/true copies
- Managing and preventing data integrity breaches
Final questions and summary discussion
Dr 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.
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
- Quality assurance/quality control
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.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.