cGMP Training

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Our GMP experts can develop a cGMP training program for your plant personnel. These services include the training of operators and maintenance personnel. Our training programs involve the following:

• Programs to ensure validation and cGMP compliance

• Identification of operational hazards by system, subsystems, and equipment

• Identification of training requirements by system and equipment

• Identification of corporate training requirements

• Identification of staffing requirements and personnel level requirements

• Criteria for a training program

Certification of the training program. We offer courses in Computer Validation, Cleaning Validation, Process Validation, Preparing for FDA Pre-approval Inspection, Failure Investigation, and other topics. Our training targets the personnel who are responsible for implementing and maintaining quality systems. The training is aimed at developing in-house cGMP, compliance, and quality standards. We train multi-functional teams including management, production operators, scientists, technicians, R&D, QC & QA, engineers, and maintenance personnel.

cGMP Audits

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• cGMP Audits

• cGMP Gap Analysis Design Reviews

• Software Quality Assurance Audits

• Pre-Approval Inspection Audit Support

• Document Review

• Laboratory audits

• Design and Review of Documentation Systems

• Change Control

• SOPs

• Environmental Monitoring

proGamma’s cGMP Audit process will ensure that your facility meets all applicable regulatory requirements. A ProGamma cGMP Audit Coordinator can be assigned to your project so full compliance with cGMPs guidelines is achieved.