GCP&GMP TRAINING

GCP:

GCP Training for ICH and FDA

HIPAA Training

Protocol, ICF, IFU and other study specific procedures

Trial Master File Development and Management

Informed Consent Process

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GMP:

Ensures that the manufacturing, packaging, labeling, and storage of investigational medicinal products (IMPs) are conducted in accordance with established quality standards

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Documentation - Maintain comprehensive and accurate documentation for all manufacturing activities, including batch records, standard operating procedures (SOPs), and protocols

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Quality Control - Implement robust quality control systems to ensure the quality, identity, purity, and strength of the investigational product

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Facility and Equipment - Establish appropriate facilities and equipment for manufacturing, packaging, and labeling activities, ensuring they are suitable, maintained, and validated

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Personnel - Employ qualified and trained personnel who possess the necessary knowledge and skills to perform manufacturing tasks effectively and in compliance with GMP requirements.

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Raw Materials - Ensure that all raw materials used in the manufacturing process meet specified quality standards and are properly tested, released, and stored

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Manufacturing Process - Develop and follow validated manufacturing processes that consistently produce investigational products meeting predetermined quality attributes

 

Packaging and Labeling - Use appropriate packaging and labeling materials that maintain the integrity of the product and comply with regulatory requirements

 

Quality Assurance - Establish an independent quality assurance function to monitor compliance with GMP and to conduct audits and inspections

 

Storage and Distribution - Maintain appropriate storage conditions to preserve the stability and integrity of investigational products during distribution and use

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Record Keeping - Maintain comprehensive records of manufacturing, packaging, labeling, testing, and distribution activities, including traceability and accountability