Consulting
- Development and implementation of effective, self-sustaining quality systems and manufacturing processes
- FDA and ISO quality systems for medical devices and pharmaceuticals
- 21 CFR Part 820 and Parts 210/211
- ISO 13485
- ISO 14971
- ICH Q7, ICH Q10
- Quality life cycle management
- Assessments, audits and gap-analysis of quality systems and manufacturing processes; due diligence for mergers and acquisitions
- Quality manuals — procedures and template development
Training
- Operational Excellence
- Six Sigma champions, yellow belt, and green belt training
- Voice of the customer
- Critical to Quality (CTQ) characteristics
- Quality function deployment (QFD)
- Process mapping
- Benchmarking
- Gap analysis
- Measurement Systems Analysis (MSA)
- Gage Repeatability and Reproducibility (Gage R&R)
- Design of Experiments (DoE)
- Transfer functions
- Response surface analysis
- Critical parameter identification and controls
- Capability scorecards
- Statistical Process Control (SPC) and Statistical Quality Control (SQC)
- Control plans
- Sustainability and process effectiveness metrics
- Statistical methods and data analysis
- Change management
- Process validation for medical devices and pharmaceuticals
- Test Method Validation (TMV)
- Corrective Action and Preventive Action (CAPA)
Testimonial
I would definitely hire Dr Sastri again for product, process, or quality initiatives, and I would strongly recommend him to any organization that wants to avail of his experience and know-how.
— Dr Luca Fontana, CEO
Aditya Birla Science & Technology Company, Ltd.