Customized in-house training available:
Whether you’re new to the medical device market or an established company, Winovia provides consulting, training, and implementation of self-sustaining, and effective quality management systems and processes for medical device manufacturers and their suppliers. Winovia has the knowledge to help you navigate medical device regulations; address Warning letters, FDA Form 483s, and ISO notified body observations; and achieve both regulatory compliance and business efficiency.
- Integrating New Product Development, Design Controls and Design for
- Design Controls
- Risk Management
- Advanced Design Controls and Risk Management
- Process Validation
- Advanced Process Validation
- Corrective Action and Preventive Action using Six Sigma Principles
- Test Method Validation
- Change Control
- Design for Six Sigma — Yellow Belt and Green belt
- Six Sigma — Yellow Belt and Green belt
- Statistical Techniques
- Strategic Technology Roadmapping
- Project Management
- Quality management systems audits, gap assessments, improvement, remediation and implementation
- Quality management systems (21 CFR Part 820, ISO 13485, ISO 9001, 21 CFR Parts 210/211)
- Management controls
- Design controls
- Risk management (ISO 14971, ICH Q9, Hazard Analysis (HA), Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Hazard Analysis Critical Control Points (HACCP))
- Production and process controls
- Process validation
- Corrective Action and Preventive Action (CAPA)
- Warning letters and consent decrees — Addressing regulatory observations, inspections and audits; developing and implementing improvements and remediation plans
- Combination Products
- Serving as Interim Quality Director or Manager
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Dr Sastri is truly an expert in his field. I personally appreciate the caliber of his treatment of this course.
Dr Sastri did a great job presenting, keeping us actively involved and answering our questions. I would look forward to attending more of his seminars.
Really excellent. The breakout sessions were productive breaks and really solidified information by applying to real case scenarios.
Very useful and professional. A lot of information to work on. I learned a lot!