Understanding and Implementing the ISO 13485 Standard
|
Course
0722
-
2
Days
-
1.4
CEUs
$995 USD
$895 USD with 30-Day Prepay Savings
$497 USD for Third Attendee
$447 USD for Third Attendee with 30-Day Prepay Savings
Save 10% to 30% in our Customer Rewards Program
"What I really took away from this course is a much better understanding of the medical device industry system, nationally and internationally. I'm new to this industry so this course was a very good introductory course to quality system management."
--Lucy Kong, Boston Scientific Corp, Target Theraputics
"Great instructor! Provided many practical examples as part of presentation. Extremely knowledgeable of subject matter."
--Ralph Musco, Consultant, Computer Associates
Key Session Topics
- Review of the ISO 13485 requirements
- Direct comparison of ISO 13485 to the FDA GMPs/QSR and ISO 9001 standard
- How to effectively implement ISO 13485
- Regulators’ approach to the ISO 13485 requirements
- Risk management (ISO 14971) requirements related to ISO 13485
- How to proceed as a company by understanding your processes
- Global Regulation Overview: How ISO13485 accepted throughout the world
- Product Liability concerns/benefits
|
Why SAI Global?
- Our courses teach real-world business objectives in an
interactive learning environment.
- Our instructors have an average of 20 years industry experience.
- We offer excellent customer service.
- We have maintained a 98.9% approval rating among more than 200,000
training participants.
|
Dates, Locations,
and Registration
You can register for a course in either of two easy ways:
- Call us at (800)374-3818.
- Click on a date in the table below and complete the online registration form.
Register online or call 800-374-3818.
If you have questions about this course,
submit a
Course Information
Request
or call us at 1-800-374-3818.
To learn about the savings and instructional benefits of training five or more participants
at your location, submit an
On-Site Quote Request
or call us at 1-800-374-3818.
To learn how you can save 10% - 30% on course registrations with SAI Global as your preferred training provider, submit a
Customer Rewards Request or call us at 1-800-374-3818.
|
Course Objectives
SAI Global’s 2-day course is the ideal learning opportunity toward understanding and successfully implementing ISO 13485. The training provides the information and guidance needed to implement and/or understand the 2003 requirements. This intense analysis will guide companies toward reviewing current processes and systems, planning for change, and understanding the challenges and benefits of meeting/certifying to ISO 13485.
Who Should Attend
- General managers
- Business unit managers
- Quality and regulatory professionals
- Management representatives
- Internal and external auditors
- Those who wish to get an understanding of the requirements and how to make them add value to your company
- Consultants needing in-depth understanding of the requirements
What's
Included in the Price
The course price includes:
- breakfast, lunch, and refreshments each course day -- special dietary needs are
no problem
- a student manual developed by experienced instructional designers
- a copy of the standard (where applicable)
- forms, templates, and worksheets for use back at the workplace (for auditing and
other applicable courses)
- certificates upon completion of course requirements
Hotels:
Although hotel reservations and accommodations are not included in the course price,
we do secure discounted room rates for most of our courses.
Training at Your Location:
Please contact us at 1-800-374-3818 for information about on-site pricing.
Support from Registration through Certificate of Completion
At every step of the public course process, the SAI Global Customer Relations team
is singularly committed to providing an unparalleled level of support so you can
focus on the learning event instead of on preparations and logistics.
- Once you register for a course by phone, by fax, or online, we send you a registration
confirmation e-mail.
- Approximately 3 weeks prior to the course, or if you register closer to the start
date, we mail and/or e-mail you precourse materials, if applicable.
- If any changes to course/hotel location occur, we contact you immediately.
- Approximately 2 weeks prior to the course start date, we e-mail you a course reminder
to confirm your attendance.
- For the course itself, we provide everything you need to facilitate your learning
experience.
- At the conclusion of the course, the instructor submits test scores (where applicable)
and other necessary paperwork to the home office for processing.
- You receive a certificate of completion and confirmation of continuing education
units (CEUs) earned.
|