Understanding ISO 13485:2016 Clause by Clause

SMF-CCL

<H3>Workshop Schedule</H3>
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21 September 2017
(1-day workshop)
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Understanding ISO 13485:2016 Clause by Clause
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$800
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21 September 2017 to 22 September 2017
(2-day workshop)
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Understanding ISO 13485:2016 Clause by Clause &amp; Being Audit-Ready for ISO 13485:2016
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Special Price: $1,700
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Trainer's Profile
The trainer for this series of workshops is no other than Mr Liew Ee Bin, member of the ISO/TC 210 WG1 drafting committee for ISO 13485:2016. Besides contributing his expertise in medical devices quality management system to ISO/TC 210 WG1, Ee Bin is also very well-versed in many facets of the medical device industry such as company establishment, global regulatory affairs, competence development, strategic marketing and international business development activities. 
 
Understanding ISO 13485:2016 Clause by Clause – From the Expert
 
Introduction
This full day workshop is designed to equip participants with the fundamental knowledge of the ISO 13485:2016 through in-depth clause by clause explanation. Mr Liew Ee Bin, who was one of the authors involved in the revision of this International Standard, will also be sharing on how the ISO 13485:2016 was conceptualised and the differences between the 2003 version and the 2016 version. Participants who are preparing for audit should also sign up for the “Being Audit Ready for ISO 13485:2016” workshop.
 
Who Should Attend?
Professionals in Quality, Regulatory, Executive Management, Manufacturing/Operations, R&D, Product Development, Supply Chain of medical technology companies still planning their transition, medical technology startups, spin-offs, companies aspiring to be in the medical technology industry, and technology transfer offices
 
What will I learn? 
<UL>
<LI>Structure of the ISO 13485:2016</LI>
<LI>Requirements of ISO 13485:2016</LI>
<LI>What are the differences between ISO 13485:2003 and ISO 13485:2016</LI>
</UL>
 What are the benefits?
<UL>
<LI>Understanding the standard is the first step towards ISO 13495:2016 certification</LI>
<LI>Interpret all clauses of ISO 13485:2016</LI>
<LI>Appreciate the importance of quality management system in manufacturing of medical devices</LI>
</UL>
What is included? 
<UL>
<LI>Training materials</LI>
<LI>Refreshments</LI>
<LI>Certificate of attendance</LI>
</UL>
 
Being Audit Ready for ISO 13485:2016
 
Introduction
This full day workshop is designed for participants who are preparing to implement ISO 13485:2016 for their organisation. Successful implementation of this revised International Standard within the 3-year transition period will require thorough planning, proper training and perfect execution by the entire team. Mr Liew Ee Bin, one of the authors involved in drafting the ISO 13485:2016, will share with participants on how to plan their timeline and resources for transition. Participants who are interested to know more about ISO 13485:2016 should also sign up for the “Understanding ISO 13485:2016 Clause by Clause – From the Expert” workshop. 
 
Who should attend?
Professionals in Quality, Regulatory, Executive Management, Manufacturing/Operations, R&D, Product Development, Supply Chain of medical technology companies still planning their transition, medical technology startups, spin-offs, companies aspiring to be in the medical technology industry, and technology transfer offices
 
 What will I learn?
<UL>
<LI>What my organisation needs to do now</LI>
<LI>How to plan the timeline for transition to ISO 13485:2016</LI>
<LI>Requirements to fulfil at each milestone towards transition</LI>
</UL>
 
What are the benefits?
<UL>
<LI>First step to a smooth transition to ISO 13485:2016</LI>
<LI>Be in full control of the transition process</LI>
<LI>No last minute panic situation to meet requirements</LI>
</UL>
 
What is included?
<UL>
<LI>Training materials</LI>
<LI>Refreshments</LI>
<LI>Certificate of attendance</LI>
</UL>
 
Mode of Payment
Cheque payment should be made to ‘SMF Centre for Corporate Learning Pte Ltd’ with the participant’s name, course title and course date. Please make full course fees payment at least 3 days before class commencement.
Payment via Cash/NETS may be made during our operating hours: 
Office Hours 9:00am to 6:00pm (Mon - Fri)
Lunch Break 12.30pm to 1.30pm

Singapore Manufacturing Federation

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Understanding ISO 13485:2016 Clause by Clause

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