METTLER TOLEDO is pleased to announce that it will be holding its Handling Risks and Errors in Pharma Record webinar, in two parts, starting next month.
Part I
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.
Moderators: Bob McDowall and Christoph Jansen
Duration: 50 minutes
10/12/2020 8:00 AM [ English ] 10/12/2020 4:00 PM [ English ] 19/05/2021 8:00 AM [ English ] 19/05/2021 4:00 PM [ English ] 25/11/2021 8:00 AM [ English ] 25/11/2021 4:00 PM [ English ] Times are given in your local time. Your current time is 07:59:48 GMT+0000 (Greenwich Mean Time).
In this Webinar we will discuss with Bob McDowall:
Part 1/2
Introduction
- 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?
Part II
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.
Moderators: Bob McDowall and Christoph Jansen
Duration: 50 minutes
11/12/2020 8:00 AM [ English ] 11/12/2020 4:00 PM [ English ] 20/05/2021 8:00 AM [ English ] 20/05/2021 4:00 PM [ English ] 26/11/2021 8:00 AM [ English ] 26/11/2021 4:00 PM [ English ] Times are given in your local time. Your current time is 07:59:49 GMT+0000 (Greenwich Mean Time).
In this Webinar we will discuss with Bob McDowall:
Part 2/2
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- 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