Data Integrity, Good Documentation Practices and Electronic Data Governance Course

Three interactive modules that tackle the requirements and the discipline needed to consistently manually document and electronically record the manufacturing and  testing of APIs, Drug Formulations, Biosimilars and Vaccines:

• FDA / EMA: Expectations for Data Integrity Ethics, Law and Transparency
• Data Integrity Reality: Detect; Panic; Investigate; Report and Repair
• Documentation Best Practices
• Electronic Data Governance in the GMP Environment

Learning Objectives:

• Regulatory Expectations and Laws regarding Data Integrity and Electronic Data Governance
• How to handle Data Integrity challenges of detection, investigation, regulatory response and CAPA
• Case Studies that describe real life examples of how companies have handled Data Integrity Issues and how the regulators reacted
• Best Practices for creating GMP appropriate Documentation
• How to encourage GMP Documentation discipline on the shop floor, warehouse and labs
• How the interactive role of the quality systems and plant management can bring about a culture of good GMP documentation
• 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 will Benefit:

• QA Personnel
• QA-IT Personnel
• IPQA Personnel
• QC Personnel
• Manufacturing Personnel
• Engineering Personnel
• Warehouse / Material Management Personnel
• GMP Management Personnel
• Rand D Personnel involved with Tech Transfer
• GMP API Personnel
• Non-GMP Intermediates Personnel
• CRO / CRAMS Personnel
• HR Personnel