GMP Solutions

InStep Training provide assistance in achieving excellence through cGMP compliance. We provide consulting services in the following areas:

• Quality Management Systems
• Regulatory Compliance Systems
• Audits
  • Audits to FDA Standards
  • Pre-Inspection Audits
  • Pre-PAI Audits
  • Vendor Audits
  • Design of Audit Programs for Manufacturing Facilities
  • Design of Audit Programs for cGMP and GLP
  • Design of Self-Audit Programs
  • Independent 3rd. Party Audits
  • Troubleshooting Audits
• cGMP
  • Management Strategy Development
  • Facilitation of cGMP Development Programs
  • Design & Facilitation of cGMP Training
  • Quality cGMP Strategies
  • Corporate cGMP Improvement Solutions
  • Functional cGMP Integration Solutions
  • cGMP and Facility Design Solutions
  • Site Surveys & Gap Analyses
• GLP
  • Assessment of System & Recommended Solutions
• Procedures
  • Manuals for Operating Standards, Instructions and Procedures
• Expert Guidance
• Quality Policies & Standards

Contact us with your specific requirements.