Effective Medical Device Validation Introduction Web 2

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Medical Device Compliance and Validation

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Section A (i) – Medical Device Compliance and Validation

Summary of product contents:

• Introduction• Regulatory Requirements & International Standards• Medical Devices• Current Good Manufacturing Practice• Key components of an effective Quality Management System

– Documentation– Auditing– Complaints and Recalls

• Approach to Process Validations• Approach to Software Validation• Design Control : Design Input & Design Output• Lifecycle Approach to Validation• - inc. Qualifications (IQ, OQ, PVS, PQ)• Approach to revalidation • The Validation Master Plan (VMP)• Process Validation Gap Analysis• Risk Based Approach to Design and Manufacturing• Other Validations• Protocol Reporting• Auditing• References

Section A (ii) – Quality Tools and Statistics

• Quality Improvement Techniques• Statistical Techniques

IntroductionIntroduction

• Why perform Product Validations? Regulatory (FDA, EU. etc.), Customers,

Business expectations, etc.

• Effort versus Risk. Risk and Process Validation.

• Integration of Validation and Risk into the product life cycle, integration into the

Quality Management System.

• Validation versus Verification.

• Definitions related to Validation.

Regulatory Requirements and Regulatory Requirements and International StandardsInternational Standards

• FDA QSR (Quality System Requirements) and Validation requirements.

• QSIT expectations.

• 21CFR 211, 21CFR 820. – pre-market assessment, risk minimisation, Part 11.

• ISO 13485:2003 expectations; ISO 14971:2009 – expectations

• Key requirements of the EU Medical Device Directives

• Revised requirements under EU Directive 2007/47/EC

• Regulatory body expectation summary

The FDA’s Draft Process Validation Guidance * • Key changes between the 1987 Process Validation Guidance and the 2008 FDA Draft.

• Comparison between FDA 2008 Draft on Process Validation and ASTM E2500.– Impact on Design and Verification

* While the 2008 Draft is not specifically “mentioned” by the CDRH, it does represent the latest in FDA thinking on Process Validation

Medical DevicesMedical Devices

• Definition

• Types of devices per the Medical Device Directives.

• Classification

• Classification rules

• Risk Assessment

Good Manufacturing Practice.Good Manufacturing Practice.

• Principles of current Good Manufacturing Practice (cGMP)

• Intended purpose/Intended Use – Quality Safety and Efficacy

• Review how GMP is implemented in the workplace. The role of the employee in delivering quality products.

Key components of an effective Quality Management SystemKey components of an effective Quality Management System

Documentation, Auditing, Complaints, RecallsDocumentation, Auditing, Complaints, Recalls

The necessity for documentation.

• Types of documentation - specifications, batch manufacturing records, non-

conformance reports, change control forms, manufacturing protocols etc.

• Standard Operating Procedures – writing, elements of, revision of.

• Fundamental documentation rules.

• Controlling official procedures.

The principles of auditing. Analysis of the steps involved in auditing manufacturing environments.

• Internal and external audits.

• Audit reports and corrective actions.

• Major audit issues.

Management of complaints and using complaints as a means to improve systems & processes.

• Components of a Recall procedure.

• Recall classification & strategy.

Approaches to Process ValidationApproaches to Process Validation

• QSIT Guide & Focus. • Focus on Production & Process Controls. (P&PC)• P&PC – Objectives, Importance, • When to Validate a Process.• Examples of processes that should be Validated.• Examples of processes that may be Verified.• How do I know if a process cannot be fully Verified?

Approach to Software ValidationApproach to Software Validation

• Guidance for Software Validations

• - GAMP Guide (Good Automated Practices)

• Categories of Software

• Software Life Cycle– User Requirements Specification– Functional Specification– Hardware Design Specification– Software Design Specification– Software Module Design Specification– Application Software Production– Module Software Test Specification– Integration Test Specification– Acceptance Test Specification– Verification Requirements & Design Specification– Verifying Test Steps, Expected Outputs and Evaluation Criteria

• Computer System Validation

• Electronic Records and Electronic Signatures

• Closed Software Systems, Audit Trail Requirements

• Extent of software validation to be performed

Design Control: Design Control: Design Input & Design Output.Design Input & Design Output.

• New Quality System Requirements for Design Controls

• Design Input & Output, Expectations, Regulations & Examples

• Rationale for new Design Control Requirements

• The Process of Design Control

• Design and Development Planning

• Design Input Types, sources, considerations, etc..

• Design Output Expectations

• Design Reviews

• Verification and Validation

• Design History File

Life Cycle Approach to ValidationLife Cycle Approach to Validation

• Benefits of a Life Cycle Approach

• Functional Requirements

• System Specifications

• Installation Qualification (I.Q.)

GHIT Guide, 820.70 requirements

Test types to be performed

Example test details

Life Cycle Approach to ValidationLife Cycle Approach to Validation continued.continued.

• Operation Qualification (O.Q.)GHIT Guide, 820.70 requirementsTest types to be performedExample test details

• Pre-Validation Study (PVS)DefinitionTests (example) to be performed

• Performance Qualification (P.Q.)DefinitionTests (example) to be performed

• Re-Qualification• Change Control• Quality Trending

RevalidationRevalidation

• Revalidation and changes

• Review and Evaluation of Revalidation

• Significance of “where appropriate” in revalidation

Validation Master Plan (VMP)Validation Master Plan (VMP)

• VMP development processWhy, Who, How, When & What.Definition

• Why is a VMP necessary?• Who prepares and approves the plan?• How do you prepare & assemble a plan?• Elements of a Validation Master Plan.• Post Validation project program descriptions.

CalibrationPreventative MaintenanceTrainingChange ControlDocument ControlRe-qualification

• Implementation of the VMP• Documenting the closure

Validation Gap AnalysisValidation Gap Analysis

• The role of gap analysis

• How to plan and develop a gap analysis to assess compliance

• Typical assessment Tools and Techniques

• Determining the methodology to use

• Preparing for issues that may be found

• Applying risk-based remediation

• Recording observations and addressing problem areas

Risk Based Approach to Design & Risk Based Approach to Design & ManufacturingManufacturing

• Why use a risk based approach?

• What are the various risk assessment models, e.g. EN ISO 14971

• What are the various Risk Assessment Tools and Techniques

Scope and Problem determination.

Severity, Probability and Detect-ability

• Advantages / disadvantages, examples, where to apply.

Other ValidationsOther Validations

• Fixture Qualification

Definition

Tests to be performed

• Component/material qualification

Definition

Content of procedure section

Protocol ReportingProtocol Reporting

• Definition

• Qualification Report Content

• Protocol Report summary

• Data Analysis Summary

• Exception statement

AuditingAuditing

• Approaches to Auditing a Validation Program

• Developing the audit terms of reference

• Scope and approach to the audit

• Auditing techniques

• Conducting a risk assessment of audit observations

Quality Tools and StatisticsQuality Tools and Statistics

Quality Improvement TechniquesQuality Improvement Techniques

• Quality Improvement process

– Define, Analyse, Root Cause, Solve, Monitor.

• Brainstorming

• Process Flow charts

– Creating a Flowchart, Analysis

• Pareto charts

– Steps to construct,

• Cause & Effect Diagrams

– Why use, how to use.

Quality Tools and StatisticsQuality Tools and Statistics Statistical TechniquesStatistical Techniques

• Introduction to Statistics/Histograms

– Mean, Mode, Range, Variance, Standard Deviation, how to construct Histograms, Normality.

• Variable Control Charts

– X-Bar, R-Charts, Control Limits, Trends, Cause of out of control limits, Corrective Action.

• Gauge repeatability and reproducibility (R+R Studies)

– Gauge selection, why perform, when to perform, benefits.

• Capability analysis

– Advantages. Types. Cp, Cpk. Interpretation.

• DPU charts

– Constructing DPU charts.

• Cycle time analysis

Thank you.

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Effective Medical Device Validation Introduction Web 2

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