Course Description:

Of the 122 warning letters issued by the FDA in 2011, 42 or 34% of them contained citations with respect to improper or ineffective process validation. Due to the complexity of many medical devices, routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of the device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This two-day seminar will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation including risk management. The hands-on training will also provide the participants the knowledge, systems, procedures and tools to implement and conduct effective process validations that are relevant to the organization’s products and processes and meet regulatory and compliance requirements. An interactive process validation exercise will be used to highlight the principles learned.

Learning Objective:

  • Understanding the intent and purpose of process validation.
  • Understanding the relationship between design controls and process validation.
  • Learning the difference between verification and validation.
  • Identifying critical process and raw material parameters.
  • Developing and executing protocols for an Installation Qualification (IQ) , Operational Qualification (OQ) and Performance Qualification (PQ).
  • Validating manual processes.
  • Understanding how to use sampling plans and determine sample sizes for process validation.
  • Populating a Device Master Record (DMR) from Process Validation.
  • Understanding the relationship between purchasing controls and process validation.
  • Understanding the relationship between risk management and process validation.
  • Maintaining a validated state including process monitoring.

Who will Benefit:

  • Operation and manufacturing managers and engineers
  • Quality Control
  • Quality Assurance
  • Consultants
  • Project Managers
  • Product design and development managers and engineers
  • Contract Manufacturers
  • Suppliers to the Medical Device Industry

Course Outline:

Day One (8:00 AM – 4:00 PM) Day Two (8:30 AM – 4:00 PM)
  • 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)

Meet Your Instructor

Vinny Sastri
President, WINOVIA® LLC

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.

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Vinny did a great job expanding on the topics using examples in class. All topics were useful for me. ComplianceOnline chose a great location for its seminar.
- Director of Operation, Minerva Surgical, Inc

Speaker was very knowledgeable. All topics were relevant to me. Discussion on engineering studies to determine critical parameters for the process validation break-out was very useful.
- Staff Scientist, Abaxis

Great Job by Vinny. Glad I Participate. All topics were valuable to me. Process Failure Mode and Effects Analysis (PFMEA), Installation qualification – IQ, Operational qualification – OQ and Performance qualification – PQ were most useful.
- Sr. Manufacturing Engineer, Minerva Surgical, Inc.

Subject matter was well chosen. Process validation topic was most valuable; understood what my company needs to do to get on board to proper process validation techniques. Got good information from other attendees.
- Manufacturing Engineer, Varian Medical Systems.

The speaker was very knowledgeable. Relationship between design requirements and critical process parameters were very informative. It was relevant to recent audit findings.
- Manufacturing Engineering Section Leader, ResMed

The presenter was excellent. Very topical content and good offline discussion. I was able to answer a lot of my open questions. ComplianceOnline chose great venue for its seminar.
- Manufacturing Engineering Manager, ResMed

Great information was presented and taught. It was easily understood with good discussions.
- Manufacturing Engineer, Varian Medical Systems

It was good seminar. All areas covered were relevant to my company. The interaction between speaker and attendees was good.
- Principal Product Engineer, MID Labs Inc.

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