Live / On-Site Training Sessions
There’s a tremendous amount of room for improvement when it comes to drafting and executing better and more complete equipment qualification protocols (IQ / OQ / PQ).
But before going any further, I'd like to pose a question to you... do any of the following circumstances seem familiar to you? How about to your business or your department?
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Do you have newly hired engineering or quality staff with less than 3-5 years of experience working in an FDA regulated environment?
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Has your organization historically struggled with equipment installations and getting equipment to work correctly (right first time)?
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Does your organization sponsor “lunch & learn” style trainings?
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Does your organization support professional development?
If you answered YES to any of these questions, your organization would be a fantastic candidate for one of our in-person training sessions!
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When it comes to equipment qualifications in a manufacturing environment, we've seen it all and we're here to help.
Live / On-Site Training Sessions
Standard Offerings & What is Included
1-Day Course
This cost-effective approach condenses what I’ve learned over the past decade of qualifying equipment in to an easy to follow, 8hr format.
This course is designed to be value-added to both engineers and quality professionals alike, and there is no pre-requisite knowledge required to attend the course.
In fact, I created this course to provide meaningful training to experienced professionals, as well as employees who may be new to FDA regulated industries and have never been asked to execute an equipment qualification before!
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In this course we will discuss:
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•Foundational, qualification knowledge
•Qualification theory
•Common pitfalls and mistakes to avoid
•The components of a qualification
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Throughout the course, attendees will be asked to participate in several practical exercises and group activities, that will reinforce the concepts being presented.
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Lunch is provided from a local vendor.
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Course attendees will leave with a spiral-bound copy of all material.
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Max Class Capacity: (8) students
2-Day Course
This course covers all of the same material as the 1-day offering but dives much deeper into other equipment qualification related topics. This is by far, my favorite course to teach, because it allows for additional time to have thought provoking discussion.
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Like the 1-day offering, this course is designed to be value-added to both engineers and quality professionals alike, and there is no pre-requisite knowledge required to attend the course.
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In this course we will discuss:
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•Expanded qualification knowledge
•Expanded qualification theory
•Common pitfalls and mistakes to avoid
•The components of a qualification
•Identifying business needs of a qualification
•Establishing ROI for qualification activities
•Deep dive into industry related case studies
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Throughout the course, attendees will be asked to participate in several practical exercises and group activities, that will reinforce the concepts being presented.
Lunch is provided from a local vendor.
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Course attendees will leave with a spiral-bound copy of all material.
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Max Class Capacity: (8) students
5-Day Course
The 5-day offering is a "Master Class," for organizations / teams.
This longer duration allows for the instructor to review and analyze the existing qualification process at your facility, provide recommendations, and help get best-practices that meet the needs of your organization implemented.
This also allows sufficient timing for an in-person practical exercise on a piece of equipment of your choosing, where the class develops an in-depth CQV plan that spans from the creation of a URS to FAT, SAT, and qualifications.
If no piece of equipment is available for the practical exercise, the class will build a mock CQV plan that can be used and implemented real-time at the next available opportunity.
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Lunch is provided from a local vendor.
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Course attendees will leave with a spiral-bound copy of all material.
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Max Class Capacity: (8) students