2001 - Present
ORAL PHARMACEUTICAL INDUSTRY
- Audit the Cleaning Validation Program
- Manufacturing Train Surface Area Calculation
- Review of Cleaning Standard Operation Procedures and Forms
- Review of Cleaning Validation Protocols
- Establish the worst-case scenario based on contact surface area, solubility, toxicity, and difficult to clean.
- Calculate and establish residues limits.
PARENTERAL & BIOTECHNOLOGY INDUSTRY
- Audit the Cleaning Validation Program
- Manufacturing Train Surface Area Calculation
- Review of Cleaning Standard Operation Procedures and Forms
- Review of Cleaning Validation Protocols
- Establish the worst-case scenario based on contact surface area, solubility, toxicity, and difficult to clean.
- Calculate and establish residues limits.
- Develop and implement the cleaning validation strategy for new drug product transfer projects.
MEDICAL DEVICE INDUSTRY
- Develop and implement Cleaning Validation Program
TRAININGS OFFERED IN CLEANING VALIDATION
cGMP Requirements for Cleaning Validation Basic Concepts of Cleaning Validation Advance Topics of Cleaning Validation How to use a Kaye Validator
