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Pharmaceutical cGMP Compliance

  • GMP Consulting

    Concentric offers customized training on a number of Good Manufacturing Practice (GMP) topics. Our comprehensive training programs are led by industry experts and are tailored to meet your specific regulatory requirements. If you work in pharma, biotech, medical device or dietary supplements, our consultants can help you comply with GMP training requirements by designing a curriculum that targets the issues your employees encounter daily. Our courses are presented at your facility or a location of your choosing which saves on expensive employee travel costs . Each course can be designed for any number of attendees. We also provide both hardcopy and digital training materials.

    With Concentric, your staff will receive training that enhances their knowledge of FDA requirements and improves compliance. Concentric offers specialized courses in:

    • Good Manufacturing Practices
    • Process Validation
    • Design Verification and Validation
    • ISO 14971 Risk Management
    • Cleaning Validation
    • Computer System Validation
    • Equipment Commissioning and Qualification
    • Facility and Utility Qualification
    • Many Others

    GMP Auditing

    Quality measures in manufacturing and laboratory operations can sometimes be overlooked - especially in small to medium sized companies. Effective programs for calibration, validation and maintenance are not established overnight and require vigilance to ensure consistent compliance. To help you avoid getting side tracked, Concentric offers third party audits to identify compliance issues before an inspector does. Our experts can assess your quality system to ensure it complies with predicate rules and make recommendations for improvement.

    Our quality experts can inspect entire operations or specific areas to provide an objective analysis of GMP compliance, including:

    • Manufacturing and packaging operations
    • Laboratory operations
    • Validation programs
    • Calibration and maintenance programs
    • Supplier quality
    • Pre-inspection assessment
    • Product and process specifications
    • Batch and test records
    • Equipment vendors including Factory and Site Acceptance Tests (FAT and SAT)

     

 

  • GMP Validation Services


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