- The flexibility of compliance, aspects of the interpretation of pharma regulations and its dynamics
- What are the risks for paper records today
- Critical aspects about USP methods that are based on observation
- Blank paper forms and the administrative overhead
- How should you assess the cost of compliance versus risk
With their focus on Data Integrity, regulation authorities are ever pushing the pharmaceutical industry towards electronic records. The number of FDA warning letters with citations of data integrity violations reveal that not every pharma company interprets the rules correctly and with an acceptable risk management policy. It's important to take a strong stance on regulation, however, conservative practices might overlook the dynamic nature of regulations, resulting in incompliance as the interpretation of rules evolve.
Join this free webinar to learn more about the ways to interpret Pharma Regulations and help your operation maintain compliance with ever-changing industry regulations.
In this Webinar we will discuss:
- What are the action items of violations and findings?
- Unofficial testing
- What do you recommend in terms of software updates?
- What is the best time to report issues?
- Cost of compliance
- Cost efficient CSV with platform solutions