Data Integrity, Good Documentation Practices and Electronic Data Governance 2019

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.

Topics

• 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.

Who should Attend

• 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