Conference - Baltimore, MD, United States
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task.
Event Institution: GlobalCompliancePanel
(Courtesy of Baltimore, MD, via en.wikipedia.org)
For more informatopn, please visit: http://bit.ly/16FQwRc
November 21, 2013 - November 22, 2013 (9:00 - 18:00)
Hilton Garden Inn Baltimore, Fremont, Maryland 21202, United States
Contact: John Robinson (support@globalcompliancepanel.com)
Phone: 8004479407
If you'd like to ask a question or post a comment about this talk please do so below.
This seminar posting is brought to you by Biotechnology Calendar, Inc. providing access to research information and research tools for nearly 20 years. Visit our Science Market Update Blog for current science funding and market information or see our schedule of upcoming science research laboratory product shows.