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Bob McDowall, experienced auditor, consultant and author of many books and papers around Electronic Records and Data Integrity Compliance for Pharmaceutical Industries. |
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.
Bob McDowall and Christoph Jansen
ca. 50 minutes
Fri Jun 26 2020 07:00 +0000 [ English ]
Fri Jun 26 2020 15:00 +0000 [ English ]
Fri Aug 28 2020 07:00 +0000 [ English ]
Fri Aug 28 2020 15:00 +0000 [ English ]
Fri Dec 11 2020 08:00 +0000 [ English ]
Fri Dec 11 2020 16:00 +0000 [ English ]
Fri Jun 26 2020 15:00 +0000 [ English ]
Fri Aug 28 2020 07:00 +0000 [ English ]
Fri Aug 28 2020 15:00 +0000 [ English ]
Fri Dec 11 2020 08:00 +0000 [ English ]
Fri Dec 11 2020 16:00 +0000 [ English ]
To learn more about the ways to interpret Pharma Regulations.
In this Webinar we will discuss with Bob McDowall:
Part 2/2
- 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
The Flexibility of Compliance and What If...? 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?
