Two days workshop on
Quality Management Systems that Comply with ISO13485:2016
Incorporating Changed or New Requirements into a New or Existing QMS
Date: Thursday, 23 February 2017 - Friday, 24 February 2017 | Location: Seattle, WA | Download Workshop Brochure
Course "Quality Management Systems that Comply with ISO13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Course Description
The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later this year. All of these events have a far reaching effect on Quality Management Systems. So, it is critical to understand what has changed within ISO 13485: 2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.

This interactive session will include lectures, round table discussions and activities all aimed at understanding key strategies and identifying specific actions to effectively improve Quality Management System Compliance. The program will also include detailed step-by-step guidance on how to develop, implement and maintain strategies in order to achieve a specific goal. Participants will want to come to the sessions with a thorough knowledge of improved company strategies and a willingness to discuss aspects of it in a confidential learning environment.

Learning Objectives
  • Gaining an understanding of the relationship between standards and quality management systems
  • Understanding the basic principles of a quality management system
  • Incorporating the Plan-Do-Check-Act approach
  • Identifying the critical elements of a quality system
  • Creating a documentation structure that is consistent with the system requirements
  • Assessing and applying risk throughout the quality system
  • Comparing the requirements of ISO 13485 to the FDA QSR
  • Understanding the differences between ISO 9001, ISO 13485: 2003 and ISO 13485: 2016
  • Understanding the QMS requirements of the proposed EU Medical Device Regulation that are not in ISO 13485: 2016
  • Establishing a plan for implementing the revised requirements of ISO 13485: 2016
Who will Benefit
Executives, Directors, Senior Managers and Functional Managers from the Medical Device Industry with responsibilities in the following areas. We encourage the participation of more than one person from each company to facilitate the creation and implementation of your action plans.
  • Quality Management Systems
  • Quality Assurance
  • Regulatory Affairs
  • Risk Management
  • Project Manager
  • Design Controls
  • Compliance
  • Standards & Regulations
  • Labeling
  • Packaging
  • Sterilization
  • Operations
OnlineCompliancePanel
Agenda

Day 1 (8:30 am – 9:00 am: Registration Process)

Anatomy of a Quality Management System

ACTIVITY : Create a QMS Outline and Identify Requirements in the Standard
  • Detailed review of all Clauses within the Standard
  • Policies and Procedures designed to drive safety and compliance
  • Supporting Documents and Databases covering operating procedures , staff training , and data management
  • Operational Procedures guiding regulatory compliance ,management involvement, and over all control of critical business functions
  • Monitoring and measuring of quality processes and operational outcomes affecting product quality and patient safety
  • Compliance and Improvement programs for audit ,inspection, and clinical information
Gap Analysis of ISO 13485: 2003 to ISO 13485: 2016
  • Increasing efficiency, cutting costs and monitoring supply chain performance through increased supplier controls
  • Increased requirements for design control
  • Covering new requirements for complaint handling, regulatory reporting and unique device identification
Application of Risk
  • Ensuring all operational procedures are following a risk based approach
  • Discussion of risk mitigation techniques and implementation
  • Identifying ways to make medical devices safer and more effective
Day 2 (9:00 am : Workshop Start)

Identification of Documentation Requirements

ACTIVITY : Required Documents Search within the Standard
  • Utilizing new Medical Device Files requirements for each family or line of devices
  • Reporting requirements to regulatory authorities
  • Enhancing product design and development through validation and design transfer
  • Preparing all necessary material for a Quality Report
Monitoring & Measurement of the QMS
  • Validating software implementation into the manufacturing process and/or quality system
  • Establishing evaluation procedures based on audit and quality reports
  • Creating a system of checks and balances to analyze QMS success
Creating a Quality Plan for QMS Updates

ACTIVITY : Create a Quality Plan to take back with you
  • Obtaining senior leadership buy into the new program
  • Outlining how to review and improve processes across your organization
  • Utilizing efficient reporting protocol and technology
  • Identifying new or existing processes and documents affected by the changes
  • Evaluating risks to the quality system associated with the QMS updates

Lena Cordie - Owner/Principal Consultant, Qualitas Professional Services, LLC


Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as director of operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labeling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.

She is an active member of AAMI (Association for the Advancement of Medical Instrumentation) - serves as a voting member of many sterilization standards committees and co-chairs the terminology committee; ISO (International Organization for Standardization) - serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups; and RAPS (Regulatory Affairs Professionals Society) - serving as chairperson of the RAPS Twin Cities Chapter.

Price/Register

Register yourself for this brainstorming session Now . You can do single registration or group or register via P.O/Check or Wire.

Register Online
Single Registration
$1,400.00
Special Group Discount
2 Attendees - Get 10% off
3 to 5 Attendees - Get 20% off
5+ Attendees - Get 30% off
Your registration fee includes the workshop, all course materials and lunch.
Register by P.O. / Check / Wire Transfer
Excited to join the workshop on "Quality Management Systems that Comply with ISO13485:2016" then register for the same by P.O. / Check / Wire Transfer. Call us Toll Free at (510)-857-5896 for any registration related assistance.

If you are Paying by Check:
Checks should be payable to Holkoi LLC and mailed to:
38780 Tyson Lane Suite 210 Fremont
California 94536, USA

Wire Transfer:
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Need Help!
In case you find difficulty in registering, availing the discount or need further information regarding the workshop, please feel free to contact our customer support team at (510)-857-5896 or send an email to customersupport@onlinecompliancepanel.com. We will help you.
Terms & Conditions to Register for the Workshop
Your registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for the workshop call us at (510)-857-5896 or email us at customersupport@onlinecompliancepanel.com

Payment Process
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to HOLKOI LLC. (our parent company)

If you are paying by check, the check should be payable to Online Compliance Panel and mailed to: 38780 Tyson Lane Suite 210 Fremont California 94536
The registration fee includes: The workshop; all related course materials; tea/coffee and lunch on both the days

Cancellations and Substitutions
For online registration, use your American Express, Visa or MasterCard.

In case you find difficulty in registering, call us at (510)-857-5896 or sent an email to customersupport@onlinecompliancepanel.com. We will help you to register hassle-free.

Any cancellation request received at least 10 calendar days prior to the start date of the event will receive a refund with a $200 administration fee deduction. No cancellations will be accepted - nor refunds issued - within 10 calendar days from the start date of the event.

On request (before the commencement of the workshop) a credit for the amount paid minus administration fees ($200) will be transferred to any future Online Compliance Panel event and a credit note will be issued. Substitutions may be made at any time.

Onsite registrations are also possible. However we accept only credit card payments and check payments. Conference material will be issued on the spot depending on the availability. In case it is not available we will send the material by post after the conference is over. In the event, Online Compliance Panel cancels the workshop; the company 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.

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

Documents to Carry
Online Compliance Panel will issue an electronic event pass to each registered candidate once the registration is confirmed. Please bring the pass to the venue of the event.
Location:

Seattle, WA

Venue/Hotel:

SHERATON SEATTLE HOTEL-1400 6th Ave, Seattle, WA 98101

Local Attractions :
Smith Tower Observation Deck

Smith Tower was once the tallest building in Seattle. Built in 1914 and restored in 1999 Smith Tower offers 360 degree views of the city, sound and mountains from its 35th floor observation deck. You can reach the deck via the human-operated elevators. This will surely be an adventurous and thrilling experience to all visitors.
Space Needle

Built in 1962 Seattle World's Fair, the 605-foot Space Needle observation tower is one of the iconic buildings of Seattle. The observation deck at the 520-foot level offers a 360-degree view of the Seattle skyline and the Cascade and Olympic Mountains. The revolving Sky City restaurant on the Space needle is a must visit place, where you can relish on Pacific Northwest cuisine.
Seattle Art Museum

Seattle Art Museum (SAM) is located in downtown Seattle. The Jonathan Borofsky's Hammering Man and Doug Aitken's Mirror are two of the noteworthy exterior features of the museum. SAM has a collection of over 23,000 objects, which includes native and Mesoamerican art to contemporary American photo and video installations.
Olympic Sculpture Park

Olympic Sculpture Park spread in nine-acres features a 2,500-foot descending, Z-shaped path connected between Belltown neighborhood in downtown Seattle with a beach on the waterfront. A range of permanent and rotating sculptures and other exotic works by world-renowned artists welcomes you at the park. The PACCAR Pavilion, a glass and steel structure that house a fluctuating exhibit, public event space as well as a cafe at the park are worth a visit. The Gates Amphitheater located adjacent to the pavilion features descending grass terraces for outdoor films and performances.
The Future of Flight Aviation Center & Boeing Tour

Located in Mukilteo, the Future of Flight Aviation Center & Boeing Tour has a 73,000-square-foot commercial jet interpretive center. The jet interpretive center is located at the west edge of the Paine Field airstrip, across from Boeing's largest jet assembly plant. The center also features an aviation gallery with interactive exhibits on commercial aviation, a theater and a roof-top observation deck to view the airport's take-offs and landings. You are sure to enjoy the 90-minute guided exploration of the largest building in the world by volume where Boeing's 747, 767, 777 and 787 Dreamliner are built.
Chihuly Garden and Glass

Located below the Space Needle on Seattle Center's 74-acre campus the Chihuly Garden and Glass is a place that no one visiting Seattle must miss. The exhibition here displays a wide-ranging collection of Washington-native Dale Chihuly's artwork ever assembled. A collection of glass, sculpture and other media displayed in both interior and exterior exhibits are its prime features.
Chinatown-International District

The Chinatown-International District spans over 44-blocks south of downtown Seattle. The Asian population in Seattle has increased steadily over a few years, and today it's the only neighborhood in the U.S. where Chinese, Japanese, Filipino, Vietnamese and Southeast Asians coexist. Take part in the Chinatown Discovery guided Tours through the district to know more on the culture and history.
Pike Place Market

Pike Place Market is one of the oldest and continuously-operated farmer's market in the U.S. Pike Place Market is spread over nine acres in the Seattle downtown. The market features everything you needs, right from fresh fish and produce, ethnic groceries and gift stores, arts and crafts, vintage clothing and more. All the visitors are sure to be entertained by street musicians, sanctioned by the Pike Place Market Preservation Development Authority PDA at the market. This is the best place to spend your evening, savoring your favorite cuisine and getting lost in music.