cGMP Services can  provide incremental, temporary resources on a part time, full time or retainer basis. This allows the greatest flexibility in predicting resource needs and limits excessive headcount for slow periods.  It facilitates sporadic peak needs such as supplier audits, program management and process and software validation.  

Design & Implementation of Requirements for Good Manufacturing Practices (GMPs) to 21 CFR Part 820, ISO 13485, ISO 9001-2000, EN 460001

Design of Quality System Regulation (QSR) Elements

• Quality System Requirements
• Design Controls
• Document Controls
• Purchasing Controls
• Identification & Traceability
• Production & Process Control
• Acceptance Activities
• Nonconforming Product
• Corrective & Preventive Action
• Labeling & Packaging Control
• Handling, Storage, Distribution & Installation
• Records
• Servicing

21 CFR Part 11 Assessment & Implementation

Regulatory Gap Analysis

Supplier Management and Supplier Audits

On-Site Internal and Mock FDA Audits

Program/Project Management

Manufacturing Management and Manufacturing Process Design

ERP Implementation (Oracle, Macola, Global Shop, Max, BPCS, MANMAN)

PLM Implementation (Agile, Omnify)

Correction Action/Preventive Action

On-Site Quality/GMP Training

Software & Process Validation

Validation Oversight Management

Program/Project Management

Training

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