Compliance with Good Manufacturing Practices (GMP) is a constant source of energy, cost, and stress for pharmaceutical and biopharmaceutical manufacturers, and staying abreast of ever-changing regulations can be a struggle. Plus, as regulators are sharing information and harmonizing approaches, existing data suggests common areas of issues being found by multiple inspectorates.
Join us for this 90-minute presentation where you will learn the latest cGMP compliance trends, including:
- Most frequently cited regulatory observations – and the trends for those observations in both US and EU inspections
- Why these issues are often cited
- Areas of interest to be prepared for – the changes to the landscape that will affect/drive inspections in the future
- How to identify areas of risk/concern in your own operation before the regulators do – steps you can take to avoid noncompliance
Some areas of increased inspectorate scrutiny include:
- Data Integrity
- Supplier Quality Agreements
- Quality Metrics
- And more!