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News Release from: Waters | Subject: Compliance webinars
Edited by the Manufacturingtalk Editorial
Team on 15 March 2007
21 CFR Part 11 and Compliance webinars
Webinars educating listeners on issues relating to compliance are to be held by Waters, presented by Victoria V Lander, Corporate Compliance Manager.
Victoria V Lander, Corporate Compliance Manager at Waters, hosts a number of Webinars educating listeners on issues relating to compliance Throughout the year, Victoria participates in a number of speaking engaugements all around the globe, and is considered a subject matter expert for FDA compliance issues that impact the regulated sectors of the pharmaceutical and biotech industry
This article was originally published on Manufacturingtalk on 11 Nov 2004 at 8.00am (UK)
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Her specific areas of expertise are the interpretation of various FDA regulations such as the so-called 'Predicate Rules', 21 CFR Parts 210, 211, 58 and 820 as well as 21 CFR Part 11, the FDA's rule governing electronic records and electronic signatures.
Victoria is also an ombudsman for Waters Corporation, speaking about her experience working with various task groups for FDA interpretation of their rules and guidelines, as well as relaying interpretation regarding FDA activities such as the GMP Initiative for the 21st Century, Critical Path Initiative and the PAT Initiative and what the Agency's current thinking behind these initiatives are.
Sometime in 2007, the US Food and Drug Administration will release its amendments to its 1997 regulation, 21 CFR Part 11.
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These revisions will result in changing the way laboratories manage their electronic records.
The goal is to create and thoroughly document a pragmatic process by which regulatory compliance initiatives can be prioritized while still maintaining overall productivity.
The deliverable is a careful, thorough risk-based methodology that enables a firm to build quality into their processes based on qualified regulatory risks and identification of key areas for increasing efficiency.
In these free Webinars, Victoria will discuss how the initiative started and the importance of these guidelines proposed by the FDA.
She will also discuss how this initiative will promote continuous improvement.
Some topics of the Webinars include: 21 CFR Part 11 Changes and Updates: This seminar will offer an update on what the changes are between the draft and the final version of this guidance document, what the impact that risk management will be on your Part 11 compliance program, and on how to develop strategies to "justify and document" risk assessment.
Risk-Based Approach to 21 CFR Part 11: This presentation will discuss the particulars of a risk-based approach to Part 11 compliance.
The favored risk assessment protocols such as HACCP, FMEA and FMECA will also be addressed as well as how one can apply them to 21 CFR Part 11 compliance.
FDA's GMP's for the 21st Century: The deliverable is a careful, thorough risk-based methodology that enables a firm to build quality into their processes based on qualified regulatory risks and identification of key areas for increased efficiency.
Currently, Waters offers an extensive library of Webinars on the topic of compliance.
Additional information about Waters' role in 21 CFR Part 11 can be found on-line.
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