cGMP Training Programs

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* Good Documentation Practices
* Good Manufacturing Practices
* Principles of Validation
* Principles of Cleaning Validation
* Risk Base Computer Systems Validation
    - Fundamentals
    - Intermediate

    - Advance

 

* Quality System Regulation for Medical Device
* Corrective Action Preventive Action (CAPA)
* Change Management Fundamentals
* FDA/EU Audit Readiness
* sFDA GMP Compliance

A well-documented and thorough GMP training program is a basic expectation of FDA inspectors of any company involved in the manufacture of therapeutic products and medical devices. Manufacturing organizations are expected to have standard operating procedures (SOPs) defining these programs. Current Good Manufacturing Practices require that training be an ongoing process.