Documenting an Effective Medical Device Quality Management System
Dan O'Leary, President at Ombu Enterprises, LLC
Coming soon.. Please contact customer care for new schedule
A medical device quality management system (QMS) can present a challenge to manufacturers. The contrast between a system that is easy to use and stands up to regulatory scrutiny presents a test. In addition, most manufacturers maintain a dual system to satisfy both FDA QSR and ISO 13485:2003. The requirements are similar, but not identical; they have about 80% overlap. The recent harmonization of EN ISO 13485:2012 raises some additional issues.
The solution, as explained in the course, is to build an integrated system that incorporates both requirements. The course uses two approaches in parallel. The first is the process approach, used in ISO 13485:2003, but introduced after FDA QSR. The second is ISO/TR 10013:2001Guidelines for quality management system documentation.
The process approach identifies the processes necessary in the QMS and prepares process maps to show the steps. The maps also show how the process interacts with other QMS processes. Process identification leads directly to questions of applicability, appropriateness, and exclusion, so the course explains them and provides examples.
The process approach implements the document hierarchy. The course explains the standard method that includes the quality manual, procedures, work instructions, forms, and records. The course examines each of these elements and explains the best practices for developing each one.
There are a number of approaches to preparing these documents, but considerations must include ease of use. To illustrate these methods, the course covers readability indices and flowchart methods to limit the amount of text.
In addition, the course explains best practices for other required documents. This includes the quality policy and objectives, quality plans, and specifications. The course describes how to develop these documents and include them in the QMS.
Process and QMS effectiveness includes measurements. The course explains how to develop metrics and apply them. In particular, metrics are an integral part of quality objectives and quality plans.The course includes many examples and exercises to help participants understand the principles and apply the methods.
Who will Benefit:
All medical device manufacturers that apply FDA QSR or ISO 13485:2003.
Meet Your Instructor
TestimonialWhat past attendees say
Dan O’Leary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.
I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.
I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.
TIt was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.
It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.
I appreciate the knowledge given at this seminar. Speaker is very experienced and I found good talent here. I am very happy with first class reference sheet.
Knowledgeable speaker with great real life examples and discussions.
It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.
It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.
I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
Cathedral of St. Paul
Built in 1915 on the highest point in the city, this cathedral is one of the largest in the country. A replica of St. Peter's in Rome, the building boasts a newly restored 175-foot-high copper dome, a massive rose window, and granite-and-travertine construction.
Frederick R. Weisman Art Museum
Set on a bluff overlooking the Mississippi River, the Weisman Art Museum is part of the University of Minnesota campus. You won't miss the trademark Frank Gehry-designed building; its fluid form defies conventional architectural lines, and its metallic finish gleams in the sunlight. The permanent collection is especially strong in American modernist paintings, ceramics, Mimbres pottery, and Korean furniture.
Historic Fort Snelling
This living history museum commemorates the establishment of a fort here in the wilderness in 1819 by Col. Josiah Snelling and his troops, who opened the area for homesteaders. Costumed guides are the focus of a living history reenactment during the summer months, re-creating the activities of everyday army life during the 1820s.
Mill City Museum
Minneapolis's Mill City Museum recounts the history of the flour industry that earned the city the nickname "Mill City" in the late 19th century. Set in the ruins of what was once the world's largest flour mill the museum re-creates old milling techniques with period equipment railroad cars and interactive exhibits. Visitors also learn the impact of the nation's first high-quality finely milled flour on the gastronomy of the Twin Cities and the country.
Minneapolis Institute of Arts
More than 5,000 years and 80,000 pieces of fine and decorative arts comprise the permanent collection at the MIA, including a 2,000-year-old mummy, European masters (Rembrandt, Titian, and Monet, among others), architectural and decorative arts, and a comprehensive photography exhibit. If you're short on time, ask for the "Highlights" brochure to make sure you don't miss the museum's best.
Minnesota History Center
An impressive array of artifacts is housed in this three-story museum, including photographs, music, and videos, all of it celebrating Minnesota history. Kids enjoy sitting in the re-created basement of a Minnesota farmhouse while a simulated tornado passes overhead. Adults enjoy listening to recordings of Minnesota musicians, including Bob Dylan, Steven Greenberg, and Prince.
Minnesota Museum of American Art
Temporary exhibits are the rule at the Minnesota Museum of American Art, which overlooks the Mississippi River. Expect edgy, contemporary installation pieces, as well as paintings, fiber art, ceramics, works on paper, and works created from found objects.
"Russia's Grizzly Coast" became the Minnesota Zoo's newest exhibit in 2008 bison pumas and wolverines -- as well as exotic mainstays like tigers camels dolphins and monkeys. The Minnesota Zoo also includes an IMAX theater and a monorail for easy navigation of the grounds.
Mississippi River Visitor Center
Located inside the entrance to the Science Museum of Minnesota , the Mississippi River Visitor Center is operated by the National Park Service and designed to educate visitors about the Mississippi National River & Recreation Area. Park rangers can assist travelers with planning outdoor excursions, including canoe and riverboat trips, hiking, biking, and birding. If you're at all outdoorsy, it's worth a stop.
Science Museum of Minnesota
Hands-on exhibits introduce visitors to natural history, science, and technology in this massive museum. Highlights include the Human Body Gallery, navigating a virtual towboat down the Mississippi River, and a collection of fossils and prehistoric specimens. In warm months check out EarthScapes Mini Golf, a new activity designed to teach earth surface dynamics. There's also an Omnitheater.
University of Minnesota
One of the Midwest's oldest (1851) and most important universities, with 50,000 students on the Twin Cities campus, the UMN offers three significant museums -- the James Ford Bell Museum of Natural History, the University Art Gallery, and the Frederick R. Weisman Art Museum .The 4,800-seat Northrop Auditorium has been a home for distinguished performances since 1929, and the University Theatre has four separate stages.
Walker Art Center/Minneapolis Sculpture Garden
The Walker Art Center is as well known for its striking architectural features as for the edgy, contemporary art inside: paintings, sculptures, drawings, photographs, and multimedia installations. A fine-dining restaurant and cafe, both by Wolfgang Puck, and gift shop are also new. Across the street is the Minneapolis Sculpture Garden, the largest urban sculpture garden in the country. A variety of 20th-century sculpture shares space with horticultural plantings, including the famous "Spoonbridge and Cherry" sculpture.
We need below information to serve you better