cGMP Compliance - Top Enforcement Trends To Prepare For
Compliance with FDA 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, regulators have stated their intent to increase inspections and audits in 2014, and the data suggests this has already started. Join us for this 90-minute presentation where you will learn the latest FDA compliance trends, including:
- Most frequently cited regulatory observations – and the trends for those observations in both the US and EU
- Why these issues are often cited – proven steps to avoid non-compliance
- 5 questions you can use to identify areas of concern (before the inspectors do)
- How to interpret data from 2013 AND 2014, plus prepare for any eventuality
This course will benefit anyone working in a GMP regulated environment on both a global or domestic scale, including quality, validation, regulatory, and all management personnel from sponsors and contract manufacturers (CMO) alike. Additionally, those who need to be able to communicate with manufacturing personnel will find this course extremely beneficial.