08. December 2020 - 13:00
Venue TBD
United StatesPhiladelphia

3-Day • ISO 13485:2016 Medical Devices—Quality Management Systems, Venue TBD, Tuesday, 08. December 2020

This is an ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes INTERNAL AUDITOR Exemplar Global Certified Course


Litts Quality Technologies, Inc. will be conducting this 3-day class in the Phildelphia, PA area. Venue TBD.


SESSION DATES 


This is a 3-day class.


8:00am – 5:00pm • Tuesday, December 8th8:00am – 5:00pm • Wednesday, December 9th8:00am – 5:00pm • Thursday, December 10th


Light snacks and lunch provided.


When you register, please provide information related to any special dietary needs, allergies, etc.


Special Needs:


We are happy to accommodate reasonable accessibility needs, including but not limited to dietary restrictions or physical assistance. Please e-mail us at email to let us know how we can assist you.



Who Should Attend:




Quality Managers




Regulatory Managers




Current Internal Auditors




Potential Internal Auditors




Auditors who want to start the process of becoming Third-Party Auditors




Purchasing employees




Any team member of an organization that is registered to or wants to become registered to ISO 13485:2016 to gain an understanding of the requirements




Please register on-line here, or email email, or call 1-877-LQT-6001 {1-877-578-6001}. 


If you have any questions regarding this information please feel free to contact us.



COURSE OBJECTIVE


The major objective of this course is to provide knowledge in the method of Leading Quality Management System (QMS) audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process.


The attendees will be able to function as Lead internal (First Party), Interested party (Second Party) and Certification Body (Third Party) auditors. 


Exercises and quizzes are used to help with the understanding of the ISO 13485:2016 Standard and Process Based Auditing Techniques.


Added benefit of taking this Certified Course:


Attendees will Receive from Exemplar Global




12 months of ongoing professional development and support through direct access to a series of tailored learning content






Exemplar Global Graduate personnel certification to enhance their employment potential






Access to complete the Exemplar Global Work Style Assessment self-coaching tool for professional growth






Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing






Continuing professional development opportunities through access to webinars, online articles, and events






Greater support on their career path





COURSE OUTLINE


DAY 1




Introductions




Course Objectives and Requirements




An overview of Exemplar Global




An overview of the International Organization for Standardization (ISO) and available resources offered




The Strategic Direction and Context of an organization 




The Concepts and Language used in the Standards




The goals and objectives of the ISO 13485:2016 Medical Device—Quality Management Systems—Requirements for Regulatory Purposes Standard, ISO 9000:2015 Quality Management Systems—Fundamentals and Vocabulary and ISO 9004:2018 Quality Management—Quality of an Organization—Guidance to achieve Sustained Success Family of Standards




Interaction of the ISO QMS Standards 




Concepts and language 




Definitions




Begin the detailed review of ISO 13485:2016 Standard Clauses with exercises through-out 





DAY 2 




Quiz




Continuing review of the detailed requirements of the ISO 13485:2016 Standard Clauses




GMP’s




The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems




The terms and definitions used in auditing




The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems


- Step 1 - Initiating the Audit


- Step 2 – Preparing Audit Activities


- Step 3 - Conducting Audit Activities


- Step 4 - Preparing, approving and distributing audit report


- Step 5 - Completing Audit 


- Step 6 - Conducting audit follow-up




Review of an Audit Procedure and related forms





DAY 3 




Quiz




Attendees review a case study and prepare to perform Mock Process Audits 




Writing audit reports




Writing requests for corrective actions




How to follow-up and close out Corrective Actions




Course Review




Complete the Exemplar Global Work Style Assessment self-coaching Tool(Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)




Final Test




Course Evaluation





COURSE MATERIALS


Litts Quality Technologies, Inc. will provide a:




Student Workbooks




Certificates





PREREQUISITES


Attendees are required to obtain a copy of the ISO 13485:2016 standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.


It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class. 


LQT Inc. will have several loaner copies of the ISO 13485:2016 Standard and ISO 19011:2018 standard available that may be shared with other attendees, during the course. These loaned copies cannot be marked-up during use.



COURSE REQUIREMENTS




A final test is administered at the end of the training session to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.




The final test is two part and attendees will have two (2) hours to complete it (Note: Anyone with special needs will be allowed an extra fifteen (15) minutes:




Part 1 - Multiple Choice – Closed Book | Part 2 – Written – Open Book 




To receive a “Successfully Completed Certificate” with the Exemplar Global Logo, an attendee must obtain a score of ≥ 70% on the final test




 If ≥ 70% is not achieved on the final test, then an attendee will receive an “Attended Certificate” without the Exemplar Global Logo




If you receive an “Attended Certificate” you can take a retest within 6 months of the last day of the class and if you score ≥ 70% you will receive a “Successfully Completed Certificate” 







COST OF THE PROGRAM


$1,350.00 per attendee. 


A 5% discount is offered for 3 or more attendees from the same organization registered at the same time.


Seating is limited so register early.


PAYMENT TERMS


Credit Card Payment or Check (received prior to the first day of the training class) are accepted.



CANCELLATION POLICY


All cancellations must be received by DECEMBER 2, 2020. After that date, any payments cannot be refunded. However, alternate attendee(s) may take the course in place of the person(s) who originally enrolled.


Litts Quality Technologies, Inc. reserves the right to cancel the training program should sufficient enrollment not be achieved by the cut-off date and shall not be responsible for any attendee costs associated with cancelled transportation or accommodation reservations.

Tuesday, 08. December 2020, Venue TBD, 3-Day • ISO 13485:2016 Medical Devices—Quality Management Systems

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