- 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
risks and errors in pharma records
Bob McDowall, известный эксперт в области целостности данных и соответствия требованиям 21 CFR часть 11 с 35-летним опытом в сфере лабораторных информационных систем. Автор более 900 публикаций и монографий по LIMS, валидации компьютерных систем и аналитическим рабочим процессам.
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.
Thu Nov 25 2021 16:00 +0000 [ English ]
In this Webinar we will discuss with Bob McDowall:
- 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?