ComplianceOnline

Implementing an effective system for corrective action and preventive action can be a major challenge. FDA illustrates the point in device Warning Letters. Since 2008, CA&PA has been the most frequently cited QSR section; about 70% of all Warning Letters includes a citation to §820.100. When expanded to the larger system in which the FDA includes nonconforming material, corrective and preventive action, and complaints, the situation gets worse.

This interactive two-day course provides the tools you need to develop and implement an effective medical device CA&PA system. In addition to FDA QSR, the course covers the corresponding requirements in ISO 13485:2016, linkage to risk management in ISO 14971:2007, and MDSAP Audit Tasks. Corrective action requirements can extend beyond the QMS to include field actions, so the course includes adverse event reporting, Corrections & Removals, Field Safety Corrective Actions, and Field Safety Notices.

CA&PA does not stand alone; it is most effective when it is an integral part of the Quality Management System and influences all of the other subsystems. The overarching objective of the course helps the participants develop the tools and methods. The course utilizes a broad variety of available material including Global Harmonization Task Force (GHTF) guidance documents, ISO guidance documents, and European Union medical device guidance documents (MEDDEV).

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • Develop the tools and methods to create an integrated CA&PA system.
  • Explain the difference between correction, corrective action, and preventive action and understand why they are different.
  • Gain knowledge of the medical device CA&PA regulatory requirements including FDA QSR and ISO 13485:2016.
  • Evaluate common problem solving and improvement methodologies, explain the quality tools, and apply them to the CA&PA system.
  • Understand "appropriate statistical methodology" to analyze data and identify existing and potential causes of quality problems.
  • Identify the linkages between complaints, corrective action, and risk management.
  • Understand the regulatory requirements for corrective actions in the field for both the US and the EU.

Who will Benefit:

While the course is specific for medical device companies, any company can benefit from an effective CAPA system. It is ideal for:

  • Quality Managers
  • Quality Engineers
  • Regulatory professionals
  • Operations Managers
  • Manufacturing Engineers
  • Risk Managers
  • Complaint system team members
  • CAPA team members
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Lecture 1 – Understanding Correction, Corrective Action, and Preventive Action
    • The Problem
    • Definitions
    • Laying Out the Language
    • Effect on the QMS
  • Lecture 2 – Quality System Regulation
    • §820.90 Nonconforming product
    • §820.100 Corrective and preventive action
    • §820.198 Complaint files
  • Lecture 3 – ISO 13485:2016
    • 8.2.2 Complaint handling
    • 8.3 Control of nonconforming product
    • 8.5.2 Corrective action
    • 8.5.3 Preventive action
  • Lecture 4 – The GHTF Guidance
    • Planning
    • Measurement and Analysis – Data Sources
    • Improvement
    • Input to Management
  • Lecture 5 – Implementing the CA&PA Requirements
    • Determining the Cause
    • Determining the Action to Take
    • Implementing the Action
    • Potential Adverse Effects
    • Checking Effectiveness
  • Lecture 6 – Auditing CA&PA
    • QSIT
    • MDSAP
Day 02(8:30 AM - 4:30 PM)
  • Lecture 7 – Quality Tools
    • Flowcharts
    • Cause and effect diagrams
    • 5 Why Analysis
    • Check Sheets
    • Pareto charts
    • Is/Is Not Analysis
  • Lecture 8 – Statistical Tools
    • Descriptive Statistics
    • Sampling
    • Hypothesis testing
    • Time series analysis
    • Statistical Process Control
    • Process Capability Analysis
    • Regression analysis
  • Lecture 9 – Complaints and CA
    • Defining a Complaint
    • Investigating a Complaint
    • Taking Corrective Action
    • Updating the Risk Management File
  • Lecture 10 – Adverse Event Reporting and Field Actions
    • US – MDRs
    • US – Corrections and Removals
    • EU – Vigilance
    • EU – FSCA & FSN
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Dan O'Leary

Dan O'Leary
President at Ombu Enterprises, LLC

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

He 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. He 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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$1,299.00

Seminar One Registration

December 7-8, 2017, Tampa, FL
(For Registrations till August 30, 2017 - $1299)
(For Registrations till September 15, 2017 - $1499)
(For Registrations till October 20, 2017 - $1599)
(For Registrations after October 20, 2017 - $1699)

$1,899.00

Seminar One Registration (With 2 Nights Stay)

December 7-8, 2017, Tampa, FL

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December 7-8, 2017, Tampa, FL
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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location

Tampa, FL
(Venue to be announced shortly)

December 7-8, 2017

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Testimonials

See What People Say About Us

With the simple approach take by Dan, anyone can learn how to complete a successful MDD implementation.

Quality Specialist, Rochester Medica

Dan OLeary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.

Quality Manager, Parker Hannifin Corp

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.

Compliance Coordinator, Diagnostica Stago, Inc.

The MDD subject matter was well illustrated by Den by flow chart and graphics. Please keep offering this subject matter.

Senior Quality Assurance Engineer, NDI Medical LLC

I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.

Quality Engineering Manager, ConvaTec Inc.

I like the medical device directive and topic regarding standards. The design of the presentations was appropriate.

Director of Research and Development, Metrex Research,LLC

It was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.

Manager, Quality Assurance, Instrumentation Laboratory

It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.

Director of Operations and Quality, NDI Medical LLC

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.

Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc

Knowledgeable speaker with great real life examples and discussions.

Quality Director, Lifecore Biomedical

It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.

QA/RA Representative, ResMed Corp

It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.

Quality Assurance, Beckman Coulter

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Benefits of becoming a Sponsor/Exhibitor/Media Partner:

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For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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Local Attractions of Tampa, FL

Museum of Science

Museum of Science & Industry (MOSI)

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.

Salvador Dali Museum

Salvador Dali Museum

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.

Tampa Museum of Art

Tampa Museum of Art

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

Craftsman House

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.

Adventure Island

Adventure Island

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.

Busch Gardens

Busch Gardens

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.

Florida Aquarium (The)

Florida Aquarium (The)

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.

John's Pass Village

John's Pass Village

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.

Lowry Park Zoo

Lowry Park Zoo

Tampa's first zoo can trace its history back to the 1930s. In 1957, this collection of animals and birds was moved to its current location. Recognized as the "Number One Family-Friendly Zoo in the U.S." by Child magazine, Lowry Park Zoo features 2,000 animals on 56 acres of lush, natural habitats comprising seven main exhibit areas: Asian Gardens, Primate World, Free-Flight Aviaries, Florida Boardwalk, Florida Manatee and Aquatic Center, Wallaroo Station children's zoo, and Safari Africa. Gift shops, refreshment stands and cafes are located throughout the park.

Moccasin Lake Nature Park

Moccasin Lake Nature Park

If you've wondered how sun and wind supply power and water and how a host of other things work, this is the spot to find out. This environmental and educational center located at a 50-acre park is highly recommended not only for its low price, but also for its fine educational offerings. You can see a lake, upland forest and wetlands environment here and spot most of the plant and animal species native to this area. A mile-long nature trail winds through the park and an Interpretative Center features wildlife exhibits, displays, information, a classroom and a laboratory.

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