Effective Quality Process Improvement for Medical Device Firms: Don’t get caught managing process through standardized SOP’s 2010

Why Should You Attend:
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. This contributes to living in pain , and the end result is a quality system bogged down by multiple procedures that are irrelevant, difficult to follow, and have morphed into something that does not fit the needs of the organization.

Areas Covered in the Seminar:

• Understanding Lean Compliance principles.
• Avoiding living in pain.
• Rules that apply in order to utilize a Lean Compliance approach.
• Advantages of utilizing Lean Compliance.
• SOP-based mindset vs. a Process-first approach.
• Steps in the Lean Compliance process.
• Walkthrough process map utilizing Lean Compliance.
• How SOP s write themselves if you have a succinct process.