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Computerized Systems – Annex 11 Revision, Data Integrity and the Quality SystemINTERACTIVE WORKSHOP
With the issuance of the WHO draft Guideline on Data Integrity in 2019, in addition to Good Data and Records Management Practice, there are at least six data integrity guidelines used by inspectors. Inspections and internal audits usually uncover data integrity issues.
- Do you have a data governance policy?
- Do you perform data integrity audits?
- Do...Continue reading
Have a question? We got all the answers
Issues to be covered
- Inspection / Audit findings and Warning letters
We all have this problem… - ALCOA+
- Regulatory Guidance:
- WHO Data Integrity Guideline, October 2019 (draft, NEW)
- FDA Guidance: Data Integrity Q&A 2018
- MHRA Data Integrity Guidance 2018
- PIC/s draft: Data Integrity in Regulated GMP/GDP Environments 2018
- EMA Q&A on Data Integrity 2016
- WHO Good Data and Record Management Practices 2016
- Data Governance Policy
- Executive Management Responsibility; Management Review
- Data Integrity Risk Assessment (DIRA)
- Mitigation Measures:
- People / Paper-based vs Automated
- Education and competency: create, sustain, monitor and improve data management throughout the organization
- Computerized systems configuration control
- Controlling access and privileges; Segregation of Duties
- Defining and controlling complete data sets
- Audit trail review: frequency, intensity and handling the findings
- Data review and approval; back-up, archives, restoration
- Outsourcing: limitations of remote SUMMARY data review in reports
The responsibility of the IND/NDA/ MAH
- Quality Unit role vs rest of management
- Company culture
- Effective Internal Audits of Data Governance
Who should attend
This course is suitable for:
Executive management in virtual companies obtaining data from outsourced operations.
Anyone working in the pharmaceutical industry including Company General Managers, Managing Directors, VPs, QPs, Quality Assurance, Quality Control and other quality professionals, Operations Managers, production managers, Research and Development, persons working in technology transfer, personnel working in pharmaceutical Active substance and finished product manufacture as well as distributors, brokers, wholesale dealers and anyone involved in the manufacture of starting materials, Active Substances, finished pharmaceuticals or involved in the handling, processing or sale or administration of any of these. Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course very useful as will regulatory personnel.
Benefits to the Participants
Participants will come away from this workshop understanding:
- ALCOA+
- Data Governance POLICY
- What are data integrity issues?
- How data integrity lapses happen
- How to conduct a Data Integrity Risk Assessment (DIRA)
- How to integrate automated / digital and digitized solutions to reduce dependence on humans and eliminate human error
About The Lecturer
