Data Integrity, Good Documentation Practices and Electronic Data Governance 2019 is a conference dedicated to the discipline needed to consistently manually document and electronically record the manufacturing & testing of APIs.
Data Integrity, Good Documentation Practices and Electronic Data Governance 2019 covers topics such as:
- How to handle Data Integrity challenges of detection, investigation, regulatory response and CAPA
- Regulatory Expectations and Laws regarding Data Integrity and Electronic Data Governance
- Best Practices for creating GMP appropriate Documentation
- Case Studies that describe real life examples of how companies have handled Data Integrity Issues and how the regulators reacted
- How the interactive role of the quality systems and plant management can bring about a culture of good GMP documentation
- How to encourage GMP Documentation discipline on the shop floor, warehouse and labs
- Electronic Data Governance: Regulatory expectations; what documents / policies / procedures should be in place; how to define the GMP boundaries around automated systems; role of Quality Assurance with automated systems; what to do and how to investigate if there are electronic data integrity problems.
Data Integrity, Good Documentation Practices and Electronic Data Governance 2019 brings together:
- QA-IT Personnel
- QA Personnel
- QC Personnel
- IPQA Personnel
- Engineering Personnel
- Manufacturing Personnel
- GMP Management Personnel
- Warehouse / Material Management Personnel
- GMP API Personnel
- R&D Personnel involved with Tech Transfer
- CRO / CRAMS Personnel
- Non-GMP Intermediates Personnel
- HR Personnel