Data Integrity is a critical issue in document governance. Document Management and Data Integrity are 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.
Data Integrity issues can apply to all life science industry sectors where data is required to fulfill regulatory requirements, including clinical trials, pharmacovigilance and manufacturing. This concise course will provide an essential understanding of the requirements for ensuring data integrity and effective Document Management in order to maintain compliance with the new regulatory requirements in this area.
Topics to be covered Include:
- Principles of Good Documentation Practice (GDP) and data integrity
- Compliance with Good Documentation Practices for linked paper and electronic records
- Regulatory guideline requirements in the EU, UK, FDA and WHO
Why you should attend
Document Management and Data Integrity are increasingly becoming a focus for regulatory inspections globally. Data Integrity issues can apply to all life science industry sectors where data is required to fulfill regulatory requirements, including clinical trials, pharmacovigilance and manufacturing. Data Integrity issues from inspection findings have resulted in a marked increase over recent years in both EU non compliance reports and FDA warning letters, as regulators are concerned about Data Integrity failures in poor documentation. Regulators, including the FDA and MHRA have reacted to this by issuing guidances that contain provisions on Data Integrity and documentation. This concise course will provide an essential understanding of the requirements for ensuring Data Integrity and effective document management in order to maintain compliance with the new regulatory requirements in this area.
Introduction & Welcome
Principles of Good Documentation Practice and Data Integrity
- What is Data Integrity?
- Why is Data Integrity important?
- ALCOA principles
- Good Documentation Practice
- MHRA / WHO / FDA / EMA / PICS/ ICH GCP R2, Data Integrity guidelines
- Group review and discussion of some key regulated documents
QMS considerations for documentation and ensuring Data Integrity
- What are the elements of QMS
- Risk management considerations
- Discussion of participants experience and best practice
Data Integrity for computer systems
- Data flow and risk considerations
- Steps for compliance
Discussion of document management and Data Integrity issues including
- Good Documentation Practices for linked paper and electronic records
- Records – Life Cycle and Data Integrity issues
- Control Mechanisms
- Validation for electronic documentation
- Data Integrity and digital signatures
- Data Integrity Governance Plans
- Certified copies/true copies
Case Study: PhelxGlobal – practical experience of the electronic TMF and Data Integrity
Document management and Data Integrity inspection findings
- MHRA, EMA findings, EU Non-Compliance Reports
- FDA finding
- Group experiences of inspection and audit
Close of Meeting
Dr Dr. Laura Brown,
Pharmaceutical Management and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA.
She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. Laura has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. In addition to her scientific qualifications, she has a degree in psychology and an MBA.
Laura is co-author of several books on management including Developing the Individual, The Ultimate Book of Business Skills and Pharmaceutical Project Management.
This course is designed for managers and staff from clinical research and other GXP areas in the pharmaceutical and medical device industries who are responsible for the creation, review, approval and reporting of data to ensure Data Integrity, including, Clinical Trials, Manufacturing, Pharmacovigilance, QC/QA and QA personnel from CROs and CMOs. GXP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from this course.
Relevant roles include those working in:
- Clinical research
- Regulatory affairs
- Quality assurance/quality control
- Legal and compliance office
- Compliance manager
- GMP compliance officers
- Heads of internal audits
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.