Process Validation - Practical Solutions and Strategies for the Medical Device

• Introduction (15 min)
• Quality Systems Regulation (21 CFR Part 820) and Standards (ISO 13485) for medical devices overview and intent (60 min)
• Key terminology
• FDA Inspections and Quality System Inspection Technique for Production and Process Controls
• Warning Letters and FDA 483’s data review
• Process Validation Guidance documents
• Process validation prerequisites (60 min)
• Manufacturing work instructions
• Buildings
• Environmental Control
• Facilities and Utilities control
• Equipment installation, maintenance and calibration
• Inspection, Measuring and Test Equipment
• Test Method Validation; Measurement Systems Analysis
• Statistical techniques, basic statistics and quality metrics calculations (60 min)
• Basic statistics overview
• Risk analysis and sampling plans
• How to determine and use sampling plans
• Sampling Plan Exercise
• Validation Master Plans (30 min)
• Verification versus Validation (30 min)
• Process development / Engineering studies - Design Controls (45 min)
• Determining essential outputs
• Determining critical process parameters
• Determining critical raw material / component characteristics
• Case study / exercise – determining the critical parameters for the process validation break-out
• Installation qualification – IQ (60 min)
• Definition of an IQ
• Elements of an IQ
• Review of an IQ Protocol and Report Template
• Exercise – Conducting an IQ

• Operational qualification – OQ (30 min)
• Definition of an OQ
• Elements of an OQ
• Review of an OQ Protocol and Report Template
• Performance qualification – PQ (30 min)
• Definition of a PQ
• Elements of a PQ
• Review of a PQ Protocol and Report Template
• Validating manual processes (15 min)
• Breakout Exercise – Conducting and analyzing an OQ and PQ (150 min)
• Automated Processes and Software validation overview (30 min)
• Outputs from Process Validation (60 min)
• Product characteristics and specifications
• Process and raw material parameters
• Process controls / control limits; process monitoring - SPC and SQC; calculating process and product capability
• Purchasing Controls and Supplier Controls (including process validation requirements)
• Process Failure Mode and Effects Analysis (PFMEA)
• Exercise – Determining process monitoring, calculating process and product capability, determining raw material requirements and specifications
• The validation life-cycle and revalidation (30 min)
• Concept of validation life-cycle
• Criteria for revalidation
• Exercise on revalidation
• Documentation (15 min)
• Documents required for the Design History File (DHF)
• Documents required for the Device Mater Record (DMR)
• Documents required for the Device History Record (DHR)
• Conclusion and wrap-up (15 min)

Dr. Vinny Sastri is the president of WINOVIA® LLC, a company that provides customized solutions, strategies, and implementation of effective product life cycle management and quality management processes. He has over 25 years of experience in quality, product development and manufacturing. Areas of expertise include product design and development, design controls, process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, manufacturing, risk management, CAPA, and plastics and materials. Dr. is a certified Six Sigma black belt and is also on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training on the FDA Quality Systems Regulation and Industry Practice to the medical device industry. Dr. Sastri’s book "Plastics in Medical Devices: Properties, Requirements and Applications" was released on April 1st, 2010 by Elsevier, London.