Data Quality and Integrity Management in GMP Environment
Data management refers to all activities performed during data lifecycle including but not limited to data policy, documentation, quality, integrity and security. Good data management practices influence the quality of all data generated and recorded by a manufacturer. These practices should ensure that data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
This online live workshop will cover data integrity, data quality, paper and electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
- Understand the current MHRA, FDA and EU GMP regulations and guidance impacting data integrity from paper records to hybrid and electronic systems
- Learn what is required for a data governance system from senior management through to staff in laboratories, manufacturing and quality assurance
- Understand the data life cycle and how it is linked with the business process and where problems can occur for both paper records, hybrid systems and electronic systems
- Understand the need for Data integrity throughout the system and data life cycles and the requirement for a data governance framework
- Learn how to implement data quality and integrity framework and governance and policies throughout the organization
- Learn how to meet the international regulatory requirements for electronic records and signatures
- Understand how to maintain Data Integrity through the operation phase of GMP life cycle
- Know why An Audit Trail and Its Review are Important:
- Part 11 and Annex 11 / Chapter 4 requirements for audit trail
- Regulatory requirements for audit trail review
- Guidance documents for audit trail review
- Do I really need an audit trail?
Who should attend?
This Live Online Training is designed for managers and staff from health care and clinical study industries as well for auditors who are responsible for the organization and execution of audit trail (reviews) in their companies:
- All those working in a GxP regulated environment that require a working knowledge of data quality and integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems
- Anyone who needs a fundamental understanding of Data Integrity regulation and risk management approaches to achieving electronic record and signature compliance
- Computer system vendors or consultants, engineering contractors, and validation service companies.
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of Data Quality Governance.
– Training material and practical examples will be distributed
– An attestation of course completion will be issued to the participants who have attended the training course.
Kossi Molley, Chemist, LSSBB, Chartered Trainer – Managing Consultant