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Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar

By:
Dan O'Leary, President at Ombu Enterprises, LLC
Location 1:-
Embassy Suites Tampa, FL

Thursday, April 24, 2014 | Friday, April 25, 2014
Location 2:-
Houston, TX

Thursday, August 14, 2014 | Friday, August 15, 2014
Location 3:-
San Francisco, CA

Thursday, November 20, 2014 | Friday, November 21, 2014

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

  • How well do you understand the requirements for supplier management?
  • Could you pass a regulatory audit or inspection without any issues?

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the supplier’s location, supplier auditing techniques, and supplier issues in management review.

The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.



Learning Objective:

Upon course completion, participants will:

  • Understand FDA QSR and ISO 13485 requirements for supplier management
  • Understand the FDA’s multi-tier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Use an analysis matrix and radar chart to compare suppliers
  • Explain the link between design control and purchasing data
  • Develop an overall supplier management plan
  • Understand the how to develop and implement supplier controls
  • Create receiving inspection criteria and apply them as part of supplier controls
  • Create supplier measurement and monitoring systems
  • Create a system for supplier business risk
  • Create a system for supplier regulatory risk
  • Create a risk based system for supplier audits
  • Develop a supplier audit using the backward trace process approach


Who will Benefit:

  • Quality Managers
  • Supply Chain Managers
  • Quality Engineers
  • Supplier Quality Engineers
  • Purchasing Professionals
  • Regulatory Specialists
  • Production and Process Engineers
  • Design and Development Engineers
  • Verification and Validation Specialists




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

  1. Introduction/Fundamentals – Regulatory Requirements
    • Supplier management in FDA QSR
    • Supplier management in ISO 13485
    • Supplier management in the EU’s Medical Device Directive
    • Acceptance activities
    • Outsourced processes
    • When suppliers have to register and list with FDA
  2. Planning the Supplier Management Program
    • Supplier management as a business process
    • Developing a business risk model for supplier management
    • Developing a regulatory risk model for supplier management
    • Case Study and exercise on risk models
  3. Planning Supplier Selection
    • Identifying what to procure
    • Role of design control, design transfer, and purchasing data
    • Identify risks (business and regulatory)
    • Identify controls (business and regulatory)
    • Case Study and exercise on developing purchasing data
  4. Potential Suppliers
    • Identify potential suppliers
    • Evaluate operational capability
    • Evaluate business capability
    • Use an analysis matrix and radar chart to compare suppliers
    • Case Study and exercise on comparative supplier analysis

  1. Supplier Selection
    • Sole source v. single source
    • The directed procurement problem
    • Evaluating the supplier, final step
    • The Approved Supplier List
    • Case Study and exercise on sole source and single source suppliers
  2. Implementing Supplier Controls
    • Building the final control plan
    • Purchase orders and contracts
    • The supplier quality agreement
    • Developing “hidden controls”
    • Receiving acceptance as a supplier control
    • Case Study and exercise on the final control plan
  3. Monitoring, Measuring, and Evaluation
    • Standard supplier metrics
    • Implementing predictive analysis
    • Developing a risk based supplier audit program
    • Using the supplier’s QMS certificate
    • The backward tracing process audit
    • Removing a supplier from the Approved Supplier List
    • Supplier management as part of Management Review
    • Case Study and exercise on the final control plan
  4. Feedback and Communication
    • Supplier scorecards
    • Corrective action requests
    • Supplier meetings
    • Case Study and exercise on supplier scorecards
  5. Evaluating your Program
    • Supplier management maturity models
    • FDA’s QSIT
    • GHTF guidance on auditing supplier control
    • Case Study and exercise on maturity models





Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

Dan O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a master’s degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.





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$1,599.00

Seminar One Registration

April 24-25, 2014, Tampa, FL

$7,299.00
$9,594.00
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April 24-25, 2014, Tampa, FL
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Seminar One Registration

August 14-15, 2014, Houston, TX

$7,299.00
$9,594.00
You Save: $2,295.00(23%)*

Special Group Discount Register for Six attendees

August 14-15, 2014, Houston, TX
*Hurry! This option is limited and based on availability.
Great Saving with Group Ticket!!! Only 3 left

$1,599.00

Seminar One Registration

November 20-21, 2014, San Francisco, CA


Price $1,599

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436

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Yes, I want to attend "Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar"

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

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Venue

Location 1:

Special Offer for the attendees of this seminar:

Rooms available at only $219 per night.

Please note: Hotel rooms are limited and based on availability




View Larger Map


How to Reach

General Driving Directions:

Driving Directions from Tampa International Airport, FL: 8.9 miles
  • Depart from Tampa International Airport, FL (0.2 mi.)
  • Keep straight onto George J Bean Pkwy (1.3 mi.)
  • Take ramp right for SR-616 toward Tampa (1.6 mi.)
  • Take ramp right for I-275 North toward Tampa (4.4 mi.)
  • At exit 44, take ramp right for Ashley Dr toward Tampa St / Downtown-West (0.4 mi.)
  • Take ramp left for Tampa St toward Convention Ctr / Aquarium-Seaport Arena / S P Times Forum / Harbor Island (0.6 mi.)
  • Keep straight onto N Tampa St (0.1 mi.)
  • Keep left onto S Tampa St (0.2 mi.)
  • Turn right onto S Franklin St (0.1 mi.)
  • Turn left onto Channelside Dr, and then immediately turn right onto S Florida Ave (0.1 mi.)
  • Arrive at S Florida Ave on the right (0.0 mi.)

From St Petersburg/Clearwater International Airport, FL: 17.8 miles
  • Depart from St Petersburg/Clearwater International Airport, FL (0.3 mi.)
  • Turn left onto SR-686 E / Roosevelt Blvd (1.1 mi.)
  • Bear left onto SR-686 E / SR-688 E / Ulmerton Rd (0.9 mi.)
  • Keep left onto SR-688 E / Ulmerton Rd (1.6 mi.)
  • Take ramp left for I-275 North toward Tampa (12.5 mi.)
  • At exit 44, take ramp right for Ashley Dr toward Tampa St / Downtown-West (0.4 mi.)
  • Take ramp left for Tampa St toward Convention Ctr / Aquarium-Seaport Arena / S P Times Forum / Harbor Island (0.6 mi.)
  • Keep straight onto N Tampa St (0.1 mi.)
  • Keep left onto S Tampa St (0.2 mi.)
  • Turn right onto S Franklin St (0.1 mi.)
  • Turn left onto Channelside Dr, and then immediately turn right onto S Florida Ave (0.1 mi.)
  • Arrive at S Florida Ave on the right (0.0 mi.)

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.



Location 2:


Location 3:




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Tampa, FL, Local Attractions

Houston, TX, Local Attractions

More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.




Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.




Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.




Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.




Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.




At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.




The Florida Aquarium gives visitors an all-access pass to the mysteries of the deep. Observe seahorses, lobsters, colorful fish, moray eels, gators, river otters, Australian sea dragons and many more. If you're feeling truly adventurous, take advantage of the "Swim with the Fishes" or "Dive with the Sharks" programs (advance reservations required). Kids will love the wide range of colorful and fun-filled interactive displays. The aquarium also sponsors ecotours aboard a 64-foot catamaran, affording patrons an opportunity to get even more up-close-and-personal with the sea. See website for complete list of attractions, calendar of events and more.




This scenic village with its nautical heritage and waterfront location offers an assortment of shops, boutiques, restaurants, water sports and entertainment. Located near the sands of Madeira Beach, John's Pass Village is renowned throughout the Bay Area as a site of good crafts and artisans, as well as casually comfortable seafood eateries. Weekends, the Village puts its best fin forward with street shows that include plenty of musical entertainment. From its boardwalk and marina, you can enjoy a free dolphin watch or take off aboard small cruise ships and fishing charters.



Located in the heart of Houston's Downtown Theater District, this 130,000 square foot entertainment megaplex is comprised of theaters, bars, lounges, and restaurants. Start the evening off with dinner at the legendary Hard Rock Café or the authentic Italian trattoria, Mingalone. Enjoy box office hits or catch the latest indie flick at the Angelika Film Center followed by drinks and dancing at ROCBAR, Houston's largest rock and roll nightclub.




The Galleria Houston, Texas's largest mall, is an upscale shopping mall centrally located just outside the 610 loop in Houston's Uptown District. The retail center is anchored by Macy's, Neiman Marcus, Nordstrom and Saks Fifth Avenue, and occupies such high-end tenants as Tiffany and Co., Dior, Louis Vuitton, and Yves Saint Laurent. The mall is also home to two separate Westin hotels.




The Lyndon B. Johnson Space Center, home of the NASA astronaut corps, is located in Southeast Houston. The center spans 1,620 acres and consists of 100 facilities. Tourists can experience a simulation of a zero-gravity environment in the Living in Space exhibit or encounter a virtual rocket launch complete with exhaust at the Blast Off Theater.




Sheltering over 4,500 animals and 900 species, The Houston Zoo is the 7th most visited zoo in the nation. Spend the day strolling through the facility's beautifully landscaped grounds or enjoy a more hands-on encounter by scheduling a guided tour. Tour experiences range from feeding a lion cub to shadowing a staff veterinarian for an entire day.




The Houston Museum District refers to the collection of museums, galleries, and cultural centers located within a 1.5 mile radius of Herman Park. The Museum of Fine Arts which also houses the Bayou Bend Collection and Gardens, boasts a collection of over 56,000 pieces. Just a few blocks away is the John P. McGovern Health Museum which is home to Houston's first and only 4D theater. Other area attractions include the Holocaust Museum, Houston Center for Photography, and the Lawndale Art Center.




Since the closing of Six Flags Astroworld, Kemah Boardwalk is now Houston's nearest and largest amusement/entertainment park. Largely occupied by hotels and restaurants, Kemah Boardwalk is an ideal place to entertain the entire family. Dining options include Landry's Seafood House, the Cadillac Bar, and Saltgrass Steakhouse. Attractions such as a Ferris wheel, train ride, and a carousel are all individually priced.




This family water park is located in North Houston (there's also a location in Galveston) and features several slides, a wild wave pool, and a lazy river. Younger guests can visit Crocodile Isle, a fully interactive children's play area complete with a pirate ship and kid-friendly slides.




One of Houston's most demographically diverse regions, Montrose has become the city's hub of vintage shopping, live music, and gay and lesbian activism. Restored mansions and bungalows, tree-lined boulevards, and an antique mall make this neighborhood a unique, pedestrian-friendly tourist spot.




Discover over 400 species of marine life and dine alongside a 150,000 gallon two-story tank at Downtown Aquarium. Witness White Tigers lounging about, pet a stingray, or go on an exhilarating train ride through the Shark Voyage. Wrap up the evening by feast on seafood entrees, steaks, and decadent desserts.




Located in North Houston, Old Town Spring is a community of shops, restaurants, and museums designed to resemble America during the early 1900's. Enjoy a nostalgic walk through the town's many Victorian-style antique shops, or catch a live music performance at the Jailhouse Saloon. Lodging options include two hotels and an RV resort.







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