Establish a regulatory compliant setting by executing best practice procedures

Implement proven auditing methods to successfully complete internal audits

Anticipate and avoid potential problems and weaknesses

Guarantee manufacturing quality by performing batch record reviews

Identify and resolve underlying issues by conducting Root Cause Analysis (RCA)

Learn to avoid FDA trigger points through proper preparation for systems-based drug cGMP and QSIT inspection

Create and maintain a change control program for precise updates, while avoiding delays

Conduct thorough and compliant supplier qualifications and quality agreements

Apply Corrective and Preventative Actions (CAPA) to properly identify, catalog and implement solutions