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Auditing and Validation Services for FDA Regulated Industry
 
 

Good Manufacturing Practice (cGMP) Audits - FDA - WHO - EMeA

Drug, Medical Device, Laboratory, Clinical, Nutraceutical, and Biotech. Industries

The Auditing Group, Inc. (TAG) - Providing extensive Auditing, Training and Remediation services supporting FDA regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable Auditing, Remediation, Validation, Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed.
US FDA - WHO - EMeA - GMP - GLP - GCP

The interpretation and application of current Good Manufacturing Practice (cGMP) is critically important in order to meet the expectations and requirements of your customers as well as the US Food and Drug Administration (FDA).

cGMPs require that manufacturers, processors, and packagers of drugs, medical devices, food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling

Not sure if your company can pass a GMP audit?

Get a 3 day on-site audit assessment and report for $5,995.00*
 - Travel and expenses included!

 

Get an independent assessment of your quality and regulatory readiness today!  Call 856-596-2333

New GMP Basic Training Courses
 


·    GMP – Good Manufacturing Practice –

o   US Parts 210/211 and Predicate Rules. 

o   EU Good Manufacturing Practice Audits,

o   Canadian GMPs,

o   Facility Audits,

o   Mock FDA Audits,

o   Department and Internal Systems,

o   Vendors and Suppliers,

o   Documentation audits,

o   ‘For-cause’ – ‘Due Diligence’ audits. 

o   Standard Operating Procedures,

o   Validation and

o   Compliance Audits.

o   Good Documentation Practice Audits

o   Good Auditing Practices

o   Quality Assurance / Quality Control Audits

o   CAPA, Recall and Complaint Systems

 

 

New GMP Basic Training Courses


GMP Publications

GXP News for the Regulated Industry Whats new with the FDAGXP Academy
GXP Recruiters - Recruiters for the BioPharmaceutical Industry

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