compliance  +  regulatory  +  training
Training - Areas of Expertise
 

SCI offers the following training services:

  • Planning and Development of Training Programs and Curricula
  • Development of Lesson Plans
  • Microbiological Laboratory Techniques and Method Validations
  • Regulatory Compliance - cGMP
  • Biosafety and Safety Awareness Training
  • Establishing the Validation Program at the Start-up Company
  • Hot Topics Workshops Series
  • Validation Concepts and Practices
  • Safety and Biosafety

Our experts have lead workshops with government organizations, pharmaceutical companies large and small, and hospital manufacturing groups. Our expertise covers the following areas:

  • Good Laboratory Practice
  • Good Manufacturing Practice
  • Regulatory Affairs Practices, including the development of Registration or Product Submissions Strategies and Documentation
  • Managing CTD Submissions
  • Technology Transfer
  • Documentation Management and Control
  • Contamination Control/Risk Assessment
  • Validation Practices
  • Worldwide Regulatory Requirements
  • Applying GMPs to Product Development
  • Computer Validation


SCI can do all the work for your company, or you can engage our help for only specific tasks. From developing the GMP training strategy, to the development of supporting SOPS and documentation, to the development of course materials and delivering the training, we can do it all.