Conference Description:

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

DATA INTEGRITY MEANS

Manual Entries: "If you didn’t write it down per ALCOA...

Electronic Transactions: "If it wasn’t validated per Part 11 with intact audit trails...

it didn't happen"
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
R&D Personnel involved with Tech Transfer
GMP API Personnel
Non-GMP Intermediates Personnel
CRO / CRAMS Personnel
HR Personnel