Training Doyens

OVERVIEW Corrective and preventive action (CAPA) is aprocess of the quality management system which, like other processes, has suppliers (other processes of the QMS), inputs such as corrective action requests and audit findings, a series of clearly defined activities, outputs, and customers.  Its deliverables (outputs) include identification of a problem's root causes, corrective or preventive actions to suppress or disable the root causes, and organizational knowledge (ISO 9001:2015 clause 7.1.6) that allows deployment of the lessons learned to related activities.  WHY SHOULD YOU ATTEND Corrective and preventive action (CAPA) is likely to be the most important process of any quality management system (QMS) because so many other activities depend on it. These include not just the traditional processes for handling poor quality, customer complaints, and audit findings but also outputs of the management review meeting and stakeholder-identified risks and opportunit...

OVERVIEW Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs (standard operating procedures) that accomplish that objective. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well-written SOPs ensure consistent process output and quality results. Standard Operating Procedures (SOPs) are acritical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well-written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work. WHY SHOULD YOU ATTEND ...

OVERVIEW Although an effective Quality Management System should always be inspection ready, many medical device companies make basic mistakes during FDA inspections leading to 483s and even warning letters.  This webinar will help you create an inspection readiness plan, so you are well prepared for an FDA inspection. WHY SHOULD YOU ATTEND An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection.  If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can especially benefit from this webinar. AREAS COVERED •  FDA Inspection approach •  Ensuring your sit...

Well-written SOPs send a message to the FDA and notified bodies that your Quality Management System (QMS) is complete, accurate, and followed and more importantly, it ensures that your personnel can consistently and accurately follow your processes, which results in correct outcomes and quality work. Our upcoming webinar discusses how to write complete, clear, unambiguous, and flexible SOPs that accomplish the objective and which your employees can understand and follow. The webinar covers the following key areas: ·          FDA expectations for SOPs and lessons learned from 483s and warning letters ·          Using process maps to make procedures clear, and mistake proofing concepts ·          Maintaining and controlling SOPs LEARNING OBJECTIVES • Overview of the regulations • FDA expectations • Lessons learned and common mistakes • SOP best pr...

OVERVIEW Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs (standard operating procedures) that accomplish that objective. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well-written SOPs ensure consistent process output and quality results. Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well-written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work. WHY SHOULD YOU ATTEND ...

OVERVIEW Although an effective Quality Management System should always be inspection ready, many medical device companies make basic mistakes during FDA inspections leading to 483s and even warning letters.  This webinar will help you create an inspection readiness plan, so you are well prepared for an FDA inspection. WHY SHOULD YOU ATTEND An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection.  If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can especially benefit from this webinar. AREAS COVERED •  FDA Inspection approach •  Ensuring your sit...

Mark Swanson Mark Swanson President/Principal Consultant, H&M Consulting Group, LLC Years of Experience:  25 years Areas of Expertise:  ISO Quality Management  Mark Swanson  (ASQ CMQ/OE, CQE, CBA)  is the President and lead consultant of  H&M Consulting Group , a group focussing on helping small to mid-sized companies having the same regulatory and quality systems knowledge as the large medical device companies. In addition to this, Mark is also the Director of the Medical Technology Quality Graduate program at St. Cloud State University. Mark has spent the last three years as an active member of  ISO Technical Committee 210 (TC210) , Working Group 1 (WG1) working on the revision of ISO 13485:2003 and has also participated with ISO TC176, WG24 on the next version of ISO 9001. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how...