Course Description:

  • Are you struggling with the implementation and maintenance of your medical device Quality System?
  • Would you like to ensure that your company operates an effective QSR and Rad Health program which meets or exceeds regulatory expectations and industry best practice standards?
  • Are your employees trained to critically identify and assess the impact new products and services will have on their overall risk assessment?
  • Is your company aware of its regulatory obligations and the potential impact of non-compliance?

This highly interactive seminar will provide answers to all these questions. Many medical laser manufacturers have failed to capture regulatory requirements for the embedded laser, UV or X-Ray components within their devices, leading to serious regulatory non-compliance issues. It would be prudent to ensure your organization’s compliance program is effective and is tailored to all applicable FDA and ISO regulatory standards prior to distribution, or finding out what possible current regulatory non-compliance issues are key risk factors within your organization’s devices.

Seminar instructor Leo J. Lagrotte is an ex-FDA official having more than two decades of experience with FDA and USDA. At FDA and USDA Mr. Lagrotte received numerous national awards / recognition certificates for exemplary performance. In 2007, he was nominated by Florida District for the Patrick Pouzar Investigator of the Year Award for exceptional performance, integrity and reliability and the FDA Outstanding Service Award in 2011.

This course on medical device QSR will provide an overview of the importance of establishing, implementing and maintaining a product specific compliance program capturing all relevant topics. The attendees will learn about the risk based approach and the essential elements of an effective risk assessment in the design and development of medical and combination medical devices. Attendees will be provided with all the tools necessary to ensure their present medical devices or planned devices meet or exceed required FDA and ISO regulations. The instructor will explain testing techniques which would assist in improving a company’s overall quality system program. Enforcement actions case studies will be reviewed as part of the course and the instructor will discuss how the same could have been prevented. It will also review key internal controls that can help prevent missing out on key requirements.

Learning Objectives:

Key goals of this course are:

  • To provide an understanding of the key elements of a medical device Quality System under FDA regulations 21 CFR 820 and ISO 13485
  • Provide an understanding of the Radiation Health Performance Standards as they apply specifically to laser/UV medical and industrial devices and short discussions on X-Ray contained devices.
  • To meet/exceed regulatory expectations and to ensure the organization is prepared to manage requirements of both converging regulations
  • To understand reporting requirements for medical devices containing radiation emitting devices.
  • The course will focus on the following key aspects of a medical device Quality System:
    • Management requirements for establishing a Quality System
    • Design controls and design change controls
    • CAPA and non-conformance regulations and monitoring
    • Complaint handling procedures
    • Adverse event reporting (MDR and vigilance)
    • Production and process controls
    • Recall and market withdrawal
    • Document control
  • The course will also discuss the Radiation Emitting Performance Standards as they refer to medical devices
    • 21 CFR 1040.10 & 1040.11- laser and UV performance standards
    • 21 CFR 1002- reporting requirements for all radiation emitting devices
    • 21 CFR 1003; 1004 and 1005, the regulations most costly to non-compliant radiation emitting device manufacturers
  • To review the key requirements to ensure your combination product meets or exceeds current regulations.

Who Will Benefit:

  • Medical device manufacturers with or without radiation emitting device
  • Internal Auditors
  • Regulators
  • Legal Departments
  • Compliance Officers
  • Program Managers

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Welcome and Introductions (30 Minutes)
  1. Understanding the Basics (1 Hour)
    • Description of Medical Devices (Leo)
      1. Classifications of Medical Devices
      2. Classifications of Radiation Emitting Devices
  2. Quality System (QSIT) (5 Hours)
    • The Quality System (Leo)
      1. The Organizational Chart
      2. Management Representative
      3. Management Responsibilities
      4. Internal and Supplier Audits
    • Design Controls and Risk Analysis (Steve)
      1. Design Controls - Design History File (DHF)
      2. Design Input and Acceptance Criteria / Design Output / Verification and Validation Method
      3. Design Review and Acceptance
      4. Design Verification – Bench Testing etc.
      5. Design Validation – Works as Intended – Clinical Study
      6. Design Transfer
      7. Design Changes
      8. Risk Assessment based on ISO 14971
        1. D.2: Energy Hazards and contributory factors
        2. D.3: Biological hazards and contributory factors
        3. D.4: Environmental hazards and contributory factors
        4. D.5: Hazards resulting from incorrect output of energy and substances
        5. D.6: Hazards relating to the use of the medical device and contributory factors
        6. D.7: Inappropriate, inadequate or over-complicated user interface (man/machine communication)
        7. D.8: Hazards arising from functional failure, maintenance and aging and contributory factors
    • Design Change Controls (Steve)
      1. Engineering Change Notice
      2. Impact to Risk Assessment
      3. Design Verification and Validation
      4. Labeling Changes
    • Document Controls and Electronic Signatures (Steve)
      1. Document Change Control – Rev changes of existing documents
      2. Document Distribution Matrix
      3. Impact on Training
    • Complaint Handling Procedures and Customer Feedback (Leo)
      1. Definition of Complaints
      2. Documentation and Control
      3. Who Handles Complaints
      4. Responsibilities and Authority
      5. Investigations and Root Cause Determination
      6. Adverse Event Reporting
      7. Handling the Regulator
    • Corrective Action and Preventative Actions (Leo)
      1. Responsibilities of Initiator
      2. Determining Root Cause and Risk Analysis
      3. Timeliness
      4. Corrective Action
      5. How to determine effectiveness of corrective actions
      6. Transactional Risk
    • Closing and Discussion (30 minutes)

Welcome (15 Minutes)

  1. QSIT Continued (3 Hours)
    • Production & Process Controls (Steve & Leo)
      1. Validate supplier (Laser) – Most likely offshore
      2. Product ordering (lasers) specifications noted
      3. Product receiving – AQL testing – mW output
      4. Device Assembly – Verification check – mW output and device functionality
      5. Labeling
      6. Packaging and Shipping – Device Traceability
    • Quality and Production
      1. Product Realization Control
      2. Responsibilities and Coordination of Quality & Production
  2. Radiation Emitting Devices (4 Hours)
    • Definitions and Classifications (Lasers) (Leo)
      1. What’s the Problem
      2. Regulations and Performance Standard Review
      3. Reporting
      4. Labeling
      5. Quality Controls and Requirements
      6. Manufacturer who utilize Laser Devices in Manufacturing of their Medical Devices.
      7. What Other FDA Regulations Pertain to Radiation Emitting Devices
  3. Conclusion/Wrap up session (30 minutes)

Meet Your Instructors

Leo J. Lagrotte
Senior Regulatory Consultant, Quality Solutions and Support, LLC

Leo J. Lagrotte is a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers as a follow-up to 20 plus years’ experience with the FDA and USDA. Mr. Lagrotte’s previous regulatory service was preceded by military service as a commissioned Officer in the US Army, and twenty plus years as a civilian owner/operator of retail food establishments including bakeries, restaurants and catering.

His experience with the FDA commenced as an investigator in Florida District/Tampa Resident Post in 2001 conducting inspections of predominately food processing establishments including all HACCP programs, LACF and Acidified Foods then advancing to Medical Devices in 2003 with the Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005 and Southeast Regional Electro-Optics Specialist for Lasers and UV devices both with medical and industrial application in 2004. He also served on the Medical Device Inspection Cadre and conducted over thirty-five foreign inspections of Medical Device, Laser, and X-Ray manufacturers. During the course of his duties with FDA, Mr. Lagrotte conducted over 500 Establishment Inspections domestically.

Presently, Mr. Lagrotte’s focus is to assist the medical device and rad health community in meeting or exceeding compliance with all FDA regulations and Notified Bodies requirements for certifications, completing 510(k) and PMA submissions and responding to regulating officials as necessary on behalf of clients. At FDA and USDA he received a numerous national awards / recognition certificates for exemplary performance. In 2007, he was nominated by Florida District for the Patrick Pouzar Investigator of the Year Award for exceptional performance, integrity and reliability and the FDA Outstanding Service Award in 2011.

Stephen Inglese
Founder and CEO, Quality Solutions and Support, LLC

Stephen Inglese is a Founder and CEO of Quality Solutions and Support, LLC. Mr. Inglese began his Quality Systems career with Florida Power and Light (FPL) Company in South Florida. During his career with FPL, he was instrumental in being awarded the prestigious Quality - Deming Award, the first United States firm to challenge then win the award once only achieved by a firm located in Japan.

During that time, Mr. Inglese was placed in a position as a facilitator and was given the opportunity to study under the direction of Japanese Union of Electrical Scientists, then teaching those within various locations of FPL under the Quality Improvement Program. During his time with FPL, Mr. Inglese was also serving in the United States Air Force Reserve. There, as a flyer in a Combat Search and Rescue Unit, he was given the opportunity to assist in the dissemination of the Total Quality Management program to a group of 500 Airman. This quality program provided the tools and techniques to achieve a successful quality improvement process. He continued his quality carrier with the Tribune Company in South Florida as a system analyst in providing data to assist in improving circulation of the firm’s local newspaper.

Mr. Inglese then transitioned to ISO 13485 and the medical device industry. He successfully maintained the ISO / FDA quality system for several medical device manufactures in the medical laser industry. During this opportunity, he created design history files for new devices and technical files to assist in marketing the devices within the United States and off shore. He led the firm through successful implementation of the Quality System as required by FDA and foreign notified bodies, internal and supplier audits and management reviews.

Mr. Inglese founded Quality Solutions and Support, LLC in 2010 to assist firms in maintaining (or developing) their Quality System be it ISO, FDA or Medical Device Directives, Health Canada or other Notified Bodies globally. This includes establishment and maintenance of these firm’s design controls, audits (internal or vendor), technical files and 510(k)s.

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Local Attractions

Explore a quaint historic town just over the Potomac River from Washington, DC. The lively waterfront area has plenty of things to do. Visit colonial houses, public parks, churches, museums, a marina, unique shops, and restaurants.

The Washington DC region is lucky to have this wonderful historic park that offers a quick relief from hectic city life. Take the whole family for a walk and learn about the historic C & O Canal, explore the region's bike trails or spend a few hours kayaking and enjoying the breathtaking scenery.

Take a picnic and enjoy spectacular views of the Potomac River at this 800 acre park, located just 14 miles from Washington DC. Great Falls offers a variety of activities including hiking, kayaking, rock climbing, bicycling, and horseback riding.

Georgetown is the capital’s historic waterfront that today is bustling with activity. The area is a shopper’s paradise and the streets are lined with restaurants of every nationality. Take a tour of historic sites, do some shopping and enjoy a meal at a local restaurant.

Explore the U.S. Capitol Building, the White House and the U.S. Supreme Court and you will gain a fuller understanding of the division of power within our democratic government. Plan ahead and note that some tours must be scheduled in advance through your Congressional Representative.

Live theatrical productions at the John F. Kennedy Center for Performing Arts are entertainment at its finest. Purchase tickets in advance for performances ranging from musicals to concerts by the National Symphony or see a free show at the Millennium Stage.

With the recent addition of the new museum and education center, Mount Vernon is now a full day excursion. Explore the state of the art galleries and theaters, visit the 500-acre estate of George Washington and his family, tour the 14-room mansion that is beautifully restored and furnished with original objects dating back to the 1740's. Be sure to plan enough time to tour the outbuildings, including the kitchen, slave quarters, smokehouse, coach house and stables. The estate is located in Northern Virginia, just minutes from Washington, DC.

Our national monuments are truly spectacular. The best time to see them is at night when they are illuminated, less crowded and parking is easier. During daytime visits, take a tour bus. Listen to informative park ranger talks and you won’t have to negotiate congested city traffic.

Start at the Smithsonian Institution Building where you can pick up a map and information on all of the museums. These national treasures cover a wide range of subjects from art to space exploration. Plan to explore those you are most interested in, but don’t try to see everything at once. Be sure to save time to see an IMAX movie at the Natural History Museum or the National Air and Space Museum.

Listen to all types of music at this national park dedicated to the performing arts. Outdoor concerts are featured in the summer and indoor performances are held the rest of the year. The park is located in Vienna, Virginia, just 20 minutes from Washington, DC.

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