We provide training, consulting, and implementation of self-sustaining, and effective quality management systems and processes for medical device manufacturers and their suppliers.

Training Courses in 2017:

Advanced Process Validation for the Medical Device Industry

May 16 – 19, 2017 (4-day training)
Chicago, Illinois, USA

Learn to properly design, develop, validate and monitor your production processes, using six sigma principles like design of experiments, sampling plans, quality metrics and process controls.

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Advanced Design Controls and Risk Management

September 27 – 29, 2017 (3-day training)
Chicago, Illinois, USA

Learn how Risk Management integrates into the Design and Development and Product Life-cycle process. Through simulation of a design through the course, participants gain an understanding of the principles of the design control elements while identifying, addressing and managing risks including usability.
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Customized in-house training available:

  • Integrating New Product Development, Design Controls and Design for
    Six Sigma (2 days)
  • Design Controls (2.5 days)
  • Change Control (2 days)
  • Risk Management (2.5 days)
  • Advanced Design Controls and Risk Management (4 days)
  • Design for Six Sigma ­— Yellow Belt (3 days) Green belt (5 days)
  • Six Sigma — Yellow Belt (3 days) Green belt (5 days)
  • Process Validation (2.5 days)
  • Advanced Process Validation (4 days)
  • Corrective Action and Preventive Action using Six Sigma Principles (3 Days
  • Test Method Validation (2 days)
  • Statistical Techniques (2 days)
  • Strategic Technology Roadmapping (2 days)
  • Project Management (2 days)

Consulting Expertise:

  • 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
  • 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!