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Conference Directory
SOP Development for Medical Device Firms:
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: CA
Number of Attendees: Unknown
Webinar or Virtual Event: No
Keywords: Document Control Facilitators,Quality Engineers,Manufacturing/Operations Engineers,Process improvement Engineers,Quality Assurance Supervisors and Managers,Production Area Supervisors and Managers.
Start Date of Conference:: 02-25-2010
End Date of Conference: 02-25-2010
Description of Conference: This Webinar will discuss how to develop SOPs with principles and skills to ensure the SOPs are simply the result of a well defined and sound processes and also meets FDA or ISO requirements.
Why Should You Attend:
The simple definition of “Lean Compliance” is implementing operationally relevant Quality System processes that effectively balance adherence to the FDA’s CFR 820 regulations, ISO13485 standards for medical devices, and the efficiency of the respective subparts or process. The end result is SOP’s or work instructions, which are needed to support the quality system, are efficient and easy to follow because they are developed by you, the way you want the associated processes to work, while assuring compliance to the regulations and standards that govern medical devices.
After all, an SOP does not drive a process; SOP’s are nothing more than the written results of a well developed process, simply documenting what is actually being done. Because of the intense scrutiny put on medical device firms by the FDA and ISO registrars, too often an organization’s approach to Quality System implementation is to develop a procedure based on the regulations/standards, and then they try to make the process fit the regulation, or, continuously add requirements to SOP’s in order to satisfy FDA, ISO, or customer audit findings. Companies also implement SOP’s in a silo (by one person or by a group in a specific company function) based on what they think an operation should be, and hope that it meets the FDA or ISO requirements. The end result is a quality system bogged down by multiple procedures that are difficult to follow, and have morphed into something that does not fit the needs of the organization.
If your medical device firm is looking to revamp your procedures and processes, or your firm has developed Quality System procedures following any of the above examples, this webinar will change your “SOP mindset”. It will review the principles and skills needed which will help to assure your SOP’s are the result of well defined, sound processes that are exactly what you want and need to run your medical device business; stripped of the fat while assuring compliance.
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SOP Development for Medical Device Firms:
