Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors

Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors
Event Dates
2015-08-27
Organizer
Event contact title
Event Manager
Event contact first name
Adam
Event contact last name
Fleaming
Email
support@compliance4All.com
Event contact telephone number
18004479407
Fax
302-288-6884
Notes
Overview: This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. Examples of each will be provided. Information will be provided to make sure your Corrective Action system including your procedures meets current FDA Quality System Regulation and ISO 13485 expectations. This includes how this leads to a robust Corrective Action system for meeting FDA Corrective Actions expectations. Why should you Attend: For many year, early in the life of ISO 9001 and ISO 13485, it to a lot of education on the part of ISO auditors to teach companies the difference between Corrections (fixing the problem) and Corrective Actions, fixing the root cause of the problem. And companies learned that well, and generally meeting expectations of their ISO auditors. However, now, although corrections are usually being done, they are usually done under other portions of ISO 13485, such as control of nonconforming product and customer feedback and complaints. These often have little visibility in the Corrective Action system, and generally do not address at all containing or correcting quality system issues that are often a major part of a Corrective Actions system. So now ISO auditors, or at least ISO 13485 Notified Body auditors, are expecting that companies now document and provide evidence that they are doing containment or correction, and quickly as well! Areas Covered in the Session: Overview of CAPA system for Current ISO 13485 compliance Why Containment and Correction have been overlooked Why this is a hot item with ISO auditors What is really the difference between correction and corrective action What kinds of containment can be done for Quality System nonconformities Defining and documenting Containment actions - Quickly Where does Preventive Action fit in Examples of Containment actions
Description
This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity.
Attendee information
Quality Managers QA Specialists CAPA coordinators Quality Engineers Engineers doing Corrective Actions Operations managers Manufacturing Engineers Quality auditors Medical device Consultants
Future dates
Thursday, August 27, 2015 | 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Minutes Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://www.compliance4all.com/control/w_product/~product_id=500406LIVE/ support@compliance4all.com www.compliance4all.com
Partner Voices
Overview: The award-winning Orange County Convention Center (OCCC) goes the extra mile to make every day extraordinary by offering customer service excellence and industry-leading partnerships. From their dedicated in-house Rigging team to their robust Exhibitor Services, The Center of Hospitality brings your imagination to life by helping you host unforgettable meetings and events. With more than 2 million square feet of exhibit space, world-class services and a dream destination, we are committed to making even the most ambitious conventions a reality. In October 2023, the Orange County Board of County Commissioners voted to approve allocating Tourist Development Tax funding for the $560 million Phase 5A completion of the OCCC. The Convention Way Grand Concourse project will include enhancements to the North-South Building, featuring an additional 60,000 square feet of meeting space, an 80,000- square-foot ballroom and new entry to the North-South Building along Convention Way. “We are thrilled to begin work on completing our North-South Building which will allow us to meet the growing needs of our clients,” said OCCC Executive Director Mark Tester. “As an economic driver for the community, this project will provide the Center with connectivity and meeting space to host more events and continue to infuse the local economy with new money and expanding business opportunities.” Amenities: The Center of Hospitality goes above and beyond by offering world-class customer service and industry-leading partnerships. From the largest convention center Wi-Fi network to custom LAN/WAN design, the Center takes pride in enhancing exhibitor and customer experience.  The OCCC is the exclusive provider of electricity (24-hour power at no additional cost), aerial rigging and lighting, water, natural gas and propane, compressed air, and cable TV services. Convenience The Center is at the epicenter of the destination, with an abundance of hotels, restaurants, and attractions within walking distance. Pedestrian bridges connect both buildings to more than 5,200 rooms and is within a 15-minute drive from the Orlando International Airport. The convenience of the location goes hand-in-hand with top notch service to help meet an event’s every need. Gold Key Members The OCCC’s Gold Key Members represent the best of the best when it comes to exceptional service and exclusive benefits for clients, exhibitors and guests. The Center’s Gold Key memberships with Universal Orlando Resort, SeaWorld Orlando and Walt Disney World greatly enhance meeting planner and attendee experiences offering world-renowned venues, immersive experiences and creative resources for their events. OCCC Events: This fiscal year, the OCCC is projected to host 168 events, 1.7 million attendees, and $2.9 billion in economic impact.  The Center’s top five events during their 2022-2023 fiscal year included:  AAU Jr. National Volleyball Championships 2023 200,000 Attendees $257 Million in Economic Impact MEGACON 2023 160,000 Attendees $205 Million in Economic Impact Open Championship Series 2023 69,500 Attendees $89 Million in Economic Impact Sunshine Classic 2023 42,000 Attendees $54 Million in Economic Impact Premiere Orlando 2023 42,000 Attendees $108 Million in Economic Impact