FDA & ISO Quality Systems

for the Medical Device & Pharmaceutical Industries
Winovia provides consulting, training, and implementation of self-sustaining, and effective quality systems and processes customized to our global clients’ needs. Winovia helps companies improve, change and transform their quality systems and processes.

Compliance makes good business sense.

Medical Device and PharmaceuticalsQuality 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.

Testimonials

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