ISO 13485 certification

GLP Training

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Background on GLP:

GLP or cGLP refers to the FDA's "current Good Laboratory Practices ". They are different applicable for Nonclinical studies for various industries regulated by the FDA. i.e. Medical Device, Human Food, and Pharmaceuticals. The GLPs are provided under the Code of Federal Regulation 21CFR58. Failure of firms to comply with GLP regulations is a federal offence and can result in disqualification of Laboratory or Testing Facilities, nonaproval of nonclinical studies, fines, and jail time.

You are required to implement processes and procedures that comply with the requirements listed in the GLPs before you can conduct studies, submit them fro approval to the FDA and release new products, you can be audited by FDA inspectors at anytime. The GLPs integrate seamlessly with ISO 9000, ISO 22000, HACCP and ISO 13485.

See information on our web-based GMP & GLP training courses at: Medical Device GMP course, Pharmaceuticals GMP course , Human Food GMP course , and GLP course.


GLP Implementation Consulting:

We offer 2 GLP implementation options depending on the resources you wish to allocate for the implementation of GLPs. All two options are SATISFACTION GUARANTEED.

 

1/ GLP Turnkey compliance consulting:

If your company wishes to have CALISO drive the implementation to comply with the GLPs, we offer an implementation service that follows a 5-step methodology: Gap assessment, Laboratory practice upgrade, GLP training, internal audit, and compliance audit. We will provide and generate all the required documentation to meet the requirements of the regulation. The implementation usually involves streamlining and simplification of your operation to take full advantage of the benefits of the GLPs. We have consultants in almost all the different states, Canada, Mexico , Europe and Africa .

Check our GLP course completion & certification success stories.

2/ Online GLP Course:

If your company has internal resources (management representative, QA Manager/Supervisor) to conduct the implementation internally and does not want to spend any money on consultants, you will need to train your staff to GLP. We offer very popular an effective online GLP course. This course comes with a 15% discount if you register 10 or more trainees. See more information on these courses at: Medical Device GMP course, Pharmaceuticals GMP course , Human Food GMP course , and FDA GLP course.

Do Not!

GLP Training Course & GLP Consulting

We guarantee your certification provided you follow our GLP Training recommendation in a timely manner. The Online GLP course, the Desk Audit and the Turnkey Consulting are satisfaction guaranteed. If you are not satisfied with our work, you will get a full refund upon return of all the documentation generated or provided. The refund covers the latest billing period for onsite consulting.

You will also have 1 year of free e-mail consulting support, where we will answer any questions you may have to help you successfully complete your certification.

To start your GLP training course or implementation call us at 1-800-306-1366 or fax us a PO at (509) 756-6053. For Option 1, there are no travel or accommodation expenses if we have a consultant in your area, otherwise, they are billed at cost. You will also need to e-mail us your Level 1 (QA Manual) and Level 2 (SOPs) and product specifications for the gap assessment preparation to tiout@caliso9000.com