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Certified Lead Auditor Course With Specific Reference to FDA Regulated Industries
(ISO 13485, ISO 9001)
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Course
0723
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5
Days
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3.6
CEUs
$1995 USD
$1795 USD with 30-Day Prepay Savings
$997 USD for Third Attendee
$897 USD for Third Attendee with 30-Day Prepay Savings
Save 10% to 30% in our Customer Rewards Program
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"The course was excellent. I learned many concepts that I will be able to apply to my own company. I feel much more competent, especially as an internal auditor."
--Julie Schraml, QA Manager, BEC Laboratories
"I was a technical instructor and director of education over 35 years prior to entering my present profession. I would have been honored to have this instructor on my staff."
--David A. Chadbourne, Quality Systems Specialist, Boston Scientific Corp.
"Excellent presentation of course material and course exercises and assignments. I've taken several courses through Excel and I have yet not found a better training provider than Excel!"
--Dave Gaspar, ASQ Certified Quality Manager & Auditor, Tytex Inc
"I learned valuable tools, techniques and ideas that will be very beneficial to my company upon implementation of this course. I would definitely recommend this course to anyone interested in learning auditing procedures. The course exceeded my objectives on day 2 already."
--Lori Goepfert, Lead Auditor, Prodesco/Secant Medical
"Prior to attending this course, I have never performed an audit and with the instructors encouragement and content communication I feel very confident and comfortable in performing future upcoming company internal and external audits."
--Salvatore Rampaul-Pino, Senior Manufacturing Engineer, Hi-tronics Designs Inc
Key Session Topics
- Introduction to the audit system and its requirements
- Quality management standards (ISO 9000, ISO 13485)
- Defining Quality Management Systems (QMS)
- Key principles of planning and controlling audits
- How to define “Quality Management System”
- Interpreting requirements in the context of an audit
- Key principles of planning and controlling audits
- How audits fit into the overall quality management system
- The role of management in the review of auditing and monitoring of the overall quality system
- How the ISO 9000 series is written and can be applied to a wide variety of circumstances
- Conduct and roles of an auditor
- The role of Team Leader
- Content and structure of a documented quality system
- Requirements of and purpose for a quality policy, quality manual, procedures, document control and record retention
- Parallels between the audit systems and ISO 19011
- How to improve questioning techniques and reporting skills
- Significance of the audit findings
- Communicate findings through the use of audit reports (e.g., nonconformity reports)
- Learn how to develop and use checklists
- Learn how to prepare nonconformity reports and present them to management
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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 five-day, highly participative course provides comprehensive instruction on auditing quality management systems. Reference is made to the international guide on quality systems auditing (ISO 19011), as well as to the ISO 9000 series standards. The training concentrates primarily on external audits, such as supplier and third-party audits. Attendees will learn how to structure, plan and time an effective audit, as well as how to evaluate and communicate the audit findings. Practical workshops, case studies, and simulated assessments are used to practice new skills and techniques.
This course includes all of the ISO 9001:2000 information from our standard lead auditor course, with the additional benefit of showing how the audit process fits with regulatory issues related to the FDA-regulated industries (food, drug, cosmetic, medical device, health care, and their suppliers).
Who Should Attend
- R&D managers/engineers
- RA/QA managers/engineers
- Management representatives
- Individuals who want to become RABQSA Certified Lead Auditors
- Individuals leading their companies to registration
- Product, project, program managers
- Internal auditors
Prerequisites
Each student is required to have studied the current published version of ISO 9001 prior to attending this course.
To become an RABQSA certified Lead Auditor:
If you satisfactorily achieve the required pass points for the written examination and the required minimum grading for the continuous assessment, you receive a certificate of “Successful Completion” to demonstrate that you have met the audit training requirements for individual QMS auditor certification by RABQSA. Before becoming a Lead Auditor there are additional requirements that must be met. Refer to the RABQSA web site (www.rabqsa.com) for further details.
Certification
This course is certified by RABQSA International, and meets the training portion of the requirements for certification of individual QMS Provisional Auditors, Auditors, and Lead Auditors.
Please click here to visit the RABQSA Web site for further details about the RABQSA auditor certification process.
If you have any further questions regarding accreditation, please call us at 1-800-374-3818.
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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