Compliance makes good business sense.Quality Systems expertise — medical device and pharmaceutical quality systems (FDA 21 CFR Parts 210, 211 and 820; ISO 13485; ICH Q7, Q8 and Q10)
Due diligence and audits — assessments and gap analysis of quality systems
Warning Letters — addressing FDA Form 483s and Warning Letters, and other regulatory body observations. Developing and implementing remediation plans
Training — quality systems, current good manufacturing practices, design controls, new product development, process validation, Six Sigma, Design for Six Sigma, test method validation, risk management, CAPA
Product development — product life cycle management, quality by design, design controls, and Design for Six Sigma
Validation — strategies, planning, procedures, protocols and templates
- Design qualification and validation
- Process validation
- Test method validation
Manufacturing — process and quality improvement; Six Sigma
Risk management — ISO 14971, and ICH Q9, risk analysis, preliminary hazard analysis (PHA), failure mode and effects analysis (FMEA), fault tree analysis (FTA), hazard analysis and critical control points (HACCP), hazard operability analysis (HAZOP), ISO 14971, and ICH Q9
Complaint handling / Corrective Action And Preventive Action (CAPA).
Documentation and technical writing — quality manuals, procedures, protocols, reports and templates
Project management — managing validation and remediation projects.
Vinny was very open to in-depth discussion about our specific circumstances. Very practical examples. Gave definite answers. Not vague. Vinny understands our business.
— On-Site Process Validation Training for Bio-Rad