SOP Development for Medical Device Firms: Utilizing ''lean compliance'' principles to meet your quality system documentation requirements

Instructor: Phil Guarino
Product ID: 701590
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

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.

Areas Covered in the Seminar:

  • Understanding Lean Compliance principles.
  • Rules that apply in order to utilize a Lean Compliance approach.
  • Advantages of utilizing a Lean Compliance.
  • SOP-based mindset vs. a Process-first approach.
  • Steps in the Lean Compliance process.
  • Walkthrough process map utilizing Lean Compliance.
  • SOP’s development as a result of a process created using a Lean Compliance Approach.

Who Will Benefit:

This webinar will provide valuable assistance to personnel in the highly regulated and document-heavy medical device industry, as well as other regulated or non-regulated industries, who are required to take part in SOP writing or process development and/or improvement activities, including:
  • Document Control Facilitators
  • Quality Engineers
  • Manufacturing/Operations Engineers
  • Process improvement Engineers
  • Quality Assurance Supervisors and Managers
  • Production Area Supervisors and Managers

Instructor Profile:
Phil Guarino, is a Managing Partner of Quality Solutions Now (QSN) a consulting firm providing regulated industries with expertise in project management, process improvement, quality system implementation and compliance, product and process development, as well as auditing and training support. Phil has entered his 22nd year working within FDA and ISO regulated industries. He has developed and implemented quality systems, performed over 200 cGMP audits, and has managed numerous FDA and ISO audits. Phil has developed and executed training programs for the medical device, Pharma, and food manufacturing industries throughout the US, Europe, Caribbean, and Asia.

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