Data Integrity, Good Documentation Practices and Electronic Data Governance 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 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 brings together: