Why Capturing Justifications in Change Control

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  • Published date: December 8, 2017
    • Fremont, California, United States

Overview:
It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result.

Areas Covered in the Session:
Determine alternatives or options to the proposed solution
Analyze costs, benefits, impacts, and risks of the proposed solution
Validate the solution, assess product impact to the market

Who Will Benefit:
Quality Assurance/Quality Control Directors, Managers,and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers,and Specialists
Engineering/Development Directors, Managers, and Specialists

Speaker Profile:
Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Compliance4All
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