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Your Best Resource |
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When it comes to meeting FDA regulatory and compliance requirements experience counts, and we deliver |
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Training |
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● QA/QC (GMP/GLP ● Regulatory affairs ● Mfg production ● Validation ● Internal auditors
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Our training programs are designed to met your specific regulatory and quality requirements and assuring that your employees get the most out of our training.
We provide training in the following areas:
● Quality Assurance and quality control
Training will be based on 21CFR 210 & 211 (GMP), 21CFR56 (GLP) and 21CFR820 (QSR), ISO 9001 and 13485 (QMS) requirements on how to maintain good manufacturing practices and documentation practices in order to be in compliance with FDA requirements.
● Regulatory Affairs
Our training will equip your employees with the skills on how to submit a successful regulatory submissions to FDA (including post approval change supplements, amendments, and post marketing requirements) and Europe for a drug approval.
● Manufacturing operation and validation
Our manufacturing and validation training will provide your employees with tools on how to work and manage a drug production operation and validation processes.
● Internal auditors
We train your employees on how to perform effective internal audits on Quality management system per ISO and FDA requirements and become certified internal auditors. |
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Quest International Consulting 26180 Enteprise Way Suite 300 Lake Forest, CA 92630 USA Phone: 949-297-4445 Fax: 949-215-3434
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Employee Training |
