Effective training is a core principle of ESI’s regulatory group. ESI’s goal is to not only to provide regulatory feedback and solutions for compliance problems while working with clients but to ensure their own personnel are adequately trained to sustain and improve the compliance of the Quality Systems after ESI’s involvement.

ESI’s team of ex-FDA employees and quality directors can deliver training on a wide range of pharmaceutical and compliance topics to cover all types of dosage forms including tablets, solution, suspension, transdermal patches, aseptically filled products, and terminally sterilized products. The format and style of training can be adapted for the client’s specific needs and training requirements. ESI can provide classroom style training with effectiveness checks, workshop trainings with hands on examples and direct mentoring and coaching of key personnel. Some example topics include:

• FDA Inspection Readiness
• Good Documentation Practices
• Investigations and Root Cause Analysis
• Data Integrity and Effective Data Review
• Change Control
• Complaints and Adverse Event Reporting

ESI’s team of scientist and engineers can also provide training and support for technical issues such as:

• Diagnosing Tableting Issues
• Transdermal Patch Adhesion and Physical Testing
• Liquids Pumping and Processing
• Coating Manufacturing and Defects Analysis
• Materials Manufacturing of Metals, Polymers, Ceramics, and Glass
• Statistical Methods