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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. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties.
There may be many networking opportunities at the 2-day In-person Seminar On "The A To Z's Of Writing And Enforcing Effective SOPs (Standard Operating Procedures)" At Baltimore, MD. Find out more in the event details below.
|Conference/Event Dates:||11/21/2013 - 11/22/2013|
|Other Industries:||Pharmaceutical, Professional Healthcare|
-Quality Assurance/Quality Control
-Marketing & Sales
-Manufacturing and Technical Services
-Clinical Research managers and personnel
-Specialists/SMEs in all departments
-QA/RA managers and personnel
-Quality System auditors
|Notes:||This Seminar will provide valuable assistance and guidance to pharmaceutical, medical device and biotechnology manufacturers and other firms in the life sciences industry who require a refresher session on writing and enforcing their own SOPs and internal procedures or for those new to this area who desire to gain a better understanding of the SOP process.|
|Venue:||Hilton Garden Inn Baltimore|
|Venue Phone:||(410) 234-0065|
|Venue Type:||Indoor - Hotel|
|Booth Size||Booth Cost||Available Amenities|
|Call for information.||Electricity:||n/a|
|Marketing Vehicles Allowed:||Call|
|Other Booth Sizes Available: n/a|
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