The Flexibility of Compliance and What If …?
2020.12.10 - 11.25
Handling Risks and Errors in Pharma Records
Handling Risks and Errors in Pharma Records - there should be procedures to stay compliant. With their focus on Data Integrity, regulation authorities are ever pushing the pharmaceutical industries 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.
Conservative practices might overlook the dynamic of regulations and might end in incompliance just because the interpretation of rules have evolved.
In this webinar we will discuss:
- The flexibility of compliance; Aspects about interpretation of pharma regulations and it's dynamics.
- What are the risks for paper records today?
- Critical aspects about USP methods that base on observation.
- Blank Paper forms and the administrative overhead.
- How should you assess the cost of compliance versus risk?
Duration: ca. 50 minutes
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