Training

Designed by experts in FDA and GxP regulations, Clarmon's training programmes help your staff meet difficult compliance demands. We can help your company develop a standard consistent global approach for computerised systems validation.

This will enable you to reduce the risk associated with inspections and regulatory agencies audits during reviews and investigations. Participating in our training courses will result in mitigation of risk exposure to non-compliance with the FDA and GxP regulatory agencies. Clarmon offers training on documentation flow, generation and execution; GxP and FDA CFR 21 Part 11 compliance standards; Quality Assurance and Quality Control programme development.

Both standard and customised training include features like: Standard User Training, Administration Configuration Training, Compliance Flow Development Training, Standard Documentation Forms Design and Configuration Training, and Customised Training.

Clarmon can also help develop internal training procedures in accordance with client needs. Standard or individually-customised training in­cludes themes and features such as:

•  General issues, e.g. GxP analysis:
• GMP (Good Manufacturing Practices)
• GCP (Good Clinical Practice)
• GLP (Good Laboratory Practice)
• GDP (Good Distribution Practice)
• Administration Configuration Training
• Com­­pliance Flow Development Training
• Standard Documentation Forms Design
• Configuration Training

Clarmon's training courses are designed by specialists in helping quality assurance and control staff meet difficult compliance demands in regulated environments.

Training sessions are targeted at participants working chiefly in the drugs manufacturing industry, in Quality Assurance or in Quality Control Departments.

Clarmon offers a standard package of trainings courses across three levels:

Training – basic

• Basic GMP
• Validation
• GMP testing
• 21 CFR Part 11

Training – advanced

• Advanced GMP
• Clean-room validation systems
• Passing an inspection
• Computer validation
• Retrospective validation

Training – GMP-Specific

• GAP analysis
• Auditor training