ISO 13485 certification

GMP Training

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Background on GMP:

GMP or cGMP refers to the FDA's "current Good Manufacturing Practice ." There are different GMPs for the various industries regulated by the FDA. i.e. Medical Device, Human Food, and Pharmaceuticals. The cGMP for medical devices is a set of quality system requirement very similar to the previous 1994 version of ISO 9000. The cGMP for Pharmaceuticals or Human Food set regulations, which have the force of law and require that manufacturers, processors, and packagers take proactive steps to ensure that their products are safe, and effective. Failure of firms to comply with GMP regulations is a federal offence and can result in recall, seizure, fines, and jail time. You are required to implement processes and procedures that comply with the requirements listed in the applicable GMP before you can release your product, you can be audited by FDA inspectors at anytime. Organizations called Registrars such as TUV or UL can verify the compliance of your organization to this federal regulation. The cGMPs integrate seamlessly with ISO 9000 and ISO 13485.

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

Among the companies we helped in their, training and compliance programs:

GMP Certification consulting:

We offer 3 options depending on the resources you wish to allocate for the implementation of GMP. All three options are SATISFACTION GUARANTEED.

1/ GMP Turnkey compliance consulting:

If your company wishes to have CALISO drive the implementation to comply with the GMP, we offer an implementation service that follows a 5-step methodology: Gap assessment, quality management system upgrade, training, internal audit, and certification audit. We will provide and generate all the required documentation to meet the requirements of the standard. The implementation usually involves streamlining and simplification of your operation to take full advantage of the benefits of the standard. We have consultants in almost all the different states, Canada, Mexico, France, Brazil and North Africa.Check our certification success stories.

We can secure for you Federal Funding to cover the majority if not the totality of the cost associated with this program.

2/ GMP Desk audit:

If your company has internal resources (management representative, QA Manager/RA Manager) and needs exacts guidance on what needs to be done, we offer desk audits that will help you comply with the standard you choose at minimal cost. We basically review all your operational documentation to identify any requirements not being met. You will need to send us a copy of your QA Manual or policies (Level 1), procedures (Level 2), and your organizational chart for a thorough audit/review on our part. The review will be under non-disclosure agreement and will maintain full confidentiality. We will then issue a detailed checklist of the modifications your system requires to comply with GMP. The checklist will be very specific to what needs to be done. We will also provide you with templates for the QA Manual (Level 1), a Continual Improvement Plan, and an Internal Audit Checklist that you can customize to meet the new requirements of the standard. Once the modifications are made, you will need to implement the changes in accordance with the recommendations in the report. The Desk Audit is available in English, French, German and Spanish.

To start your implementation you would need to fax us a PO at (510) 217-6621 and e-mail us your Level 1 (QA Manual) and Level 2 (Procedures) to

3/ Online training:

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 GMP. 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 Food Supplement GMP course.

Do Not!

We guarantee your certification provided you follow our GMP Training recommendation in a timely manner. The Online Training, 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 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 (Procedures) and product specifications for the gap assessment preparation to