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Internal Auditor Training for FDA Regulated Industries (ISO 13485:2003 and ISO 9001:2000)
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Course
0724
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2
Days
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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
“The instructor showed practical examples that were appropriate teaching aids and made the course a very fun, yet professional experience.”
-–Luis A. Di Donato, Manufacturing Engineer, Innovative Surgical Products
Key Session Topics
- How to develop an effective Quality System Audit Program:
Audit principles and objectives
Internal audit team selection, training and skill development
- Overview Quality Management Systems (ISO 13485:2003, ISO 9001:2000, QSR)
- Developing effective audit techniques
- Auditor skills and attributes
- Identifying key activities for performing a successful audit
- How to utilize your existing resources
- Construction of an effective audit program:
Planning, scheduling and administering
Developing checklists and documentation reviews
- Auditing for process effectiveness versus compliance
- Quality system improvement through corrective action; developing and implementing corrective action programs
- Evaluating the significance of audit findings
- Improving communication skills for the presentation of audit findings
- Reporting the findings and evaluations
- Auditing continual improvement programs
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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.
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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.
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Course Objectives
This two-day course provides the information and skills needed to effectively perform a comprehensive quality system audit that complies with ISO 13485:2003, ISO 9001:2000 and regulatory requirements. Using interactive workshops, simulated audits, tutorials and case studies, you will develop practical audit skills, improve your evaluation and communication skills, refine your reporting skills and increase your ability to implement corrective action programs.
This course includes ISO 13485:2003 as well as all of the ISO 9001:2000 information from SAI Global's standard internal auditor course, with the additional benefit of showing how the audit process fits with regulatory issues related to FDA-regulated industries (food, drug, cosmetic, medical device, healthcare, and their suppliers).
Through lectures, practical and interactive workshops and simulated audits, attendees will practice and refine auditing techniques.
Who Should Attend
- Internal auditors
- Quality professionals
- Management representatives
- RA/QA managers/engineers
- R&D managers/engineers
- Product, project, program managers
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.
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