Introduzione
Data Integrity and Data Governance
Data integrity is a fundamental element of pharmaceutical quality and regulatory compliance. Regulators expect organisations to demonstrate that GxP data are complete, consistent, accurate, attributable and reliable throughout the entire data lifecycle. Failure to meet these expectations can compromise confidence in the data used to support product quality and may result in significant regulatory findings.
This practical workshop provides participants with a clear understanding of Data Integrity principles and how they apply to both paper and electronic records. The course explores the ALCOA+ principles in detail and translates them into practical expectations for everyday activities, including documentation, electronic systems, audit trails, data transcription, record review, calculations and critical process data.
Emphasis is placed on identifying Data Integrity vulnerabilities, distinguishing accidental failures from intentional falsification, assessing the criticality and impact of Data Integrity deficiencies, and designing processes and controls that reduce opportunities for errors and non-compliance.
Through real regulatory observations and practical workshops, participants will apply Data Integrity concepts to realistic pharmaceutical scenarios and identify appropriate corrective and preventive actions.
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Introduction to Data Integrity
- Why Data Integrity matters in GMP environments
- Regulatory expectations and common areas of concern
- Data Integrity throughout the data lifecycle
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ALCOA+ Principles
- Understanding the ALCOA+ framework
- Application to paper and electronic records
- Good documentation and record-management practices
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Data Integrity Risks and Vulnerabilities
- Common weaknesses in processes, documentation and systems
- Accidental errors versus intentional data falsification
- Data criticality and impact assessment
- Classification of Data Integrity deficiencies
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Controls and Data Governance
- Roles, responsibilities and appropriate access controls
- Review and verification of GMP data
- Traceability, audit trails and management of original records
- Risk-based controls according to data criticality
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Regulatory Expectations and Case Studies
- Examples of Data Integrity findings from regulatory inspections
- Analysis of common compliance failures
- Lessons learned from real inspection observations
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Investigation, CAPA and Prevention
- Identifying the underlying causes of Data Integrity failures
- Developing appropriate corrective and preventive actions
- Improving process and documentation design
- Strengthening Quality Culture and preventing recurrence
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Practical Workshop
- Application of ALCOA+ principles
- Assessment of Data Integrity deficiencies and criticality
- Identification of process vulnerabilities
- Development of appropriate remediation actions
This course is designed for professionals who generate, review, approve or manage GMP data and for those responsible for ensuring its integrity and compliance throughout the data lifecycle.
It is relevant both for professionals who want to build a solid understanding of Data Integrity principles and for experienced personnel looking to strengthen their ability to identify vulnerabilities, assess potential deficiencies and support a robust Data Integrity culture within their organisation.
The course is particularly suitable for:
- Quality Assurance professionals
- Quality Control and laboratory personnel
- Manufacturing and Operations personnel
- Regulatory Compliance professionals
- Validation and Computerised Systems professionals
- Engineering and Technical Operations personnel
- Data Governance and Data Integrity specialists
- Document Control personnel
- Supervisors and managers responsible for GxP activities
- Internal auditors
- Subject Matter Experts involved in regulatory inspections
- Personnel responsible for reviewing batch records, laboratory records or electronic data
Participant Experience
A basic understanding of GMP documentation principles is recommended.
Previous specialist experience in Data Integrity is not required. The course is suitable both for professionals seeking to understand the fundamentals of Data Integrity and for experienced personnel who want to strengthen their ability to identify vulnerabilities and assess Data Integrity deficiencies.
This is an interactive, instructor-led workshop with a strong practical focus.
The training combines key regulatory and Data Integrity concepts with real FDA inspection observations, pharmaceutical case studies, group discussions and hands-on exercises.
Participants will work on practical activities including data criticality assessment, process mapping, identification of Data Integrity vulnerabilities and CAPA development, with a focus on translating ALCOA+ principles into effective documentation and process controls.
Docente/i
Andrés Gola Isasi
Andres Gola Isasi is a Life Science Regulatory Compliance professional with extensive experience in the pharmaceutical, biotechnology and medical device industries. His expertise covers Regulatory Affairs, Quality Assurance, GMP compliance, investigations, Root Cause Analysis, CAPA systems, Human Factors and regulatory inspections.
Throughout his career, he has supported international life science organisations in quality and regulatory projects, including deviation investigations, CAPA improvement, inspection readiness, remediation activities and quality-system optimisation. He also combines his consulting experience with university teaching and professional training in Regulatory Affairs, Quality and Project Management.
Online Training – 2 modules
MODULE 1 | 03 May 2027 from 2:30 pm to 5:30 pm CEST
MODULE 2 | 05 May from 2:30 pm to 5:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 690,00* (until 12 April 2027)
Ordinary: € 885,00*
Freelance – Individual – Academy – Public Administration**: € 495,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Metodi di pagamento accettati: Bonifico bancario, Carta di credito, PayPal.
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.