QMS REQUIREMENTS TRAINING

 

April 28th - 29th, 2010

 

Agenda

 

Discussion:  Compare Participants’ experience and knowledge of Quality Management System requirements and regulations as well as discuss expectations for this course

 

Exercise:  Key Terms and Definitions

 

I.            Introduction

 

·        Identify medical device classes and associated regulatory requirements

·        Review QMS scope

·        Explain evolution of cGMP's and QMS standards

·        ISO vs. FDA

·        Why compliance, what is required, how do we do it

·        General QMS requirements and QMS related recalls

·        Present the "Process Approach"

·        Discuss benefits to applying the process approach

·        Outline FDA's QSIT approach and pilot program findings

·        Review key terms and definitions

·        Review the Quality Management System Requirements using the FDA QSR subpart format

 

Answers:  Key Terms and Definitions

 

 

II.            Quality System Requirements

 

Discussion:  Discuss participants varying quality policies and measurement of success

 

·        Examine management responsibility requirements

 

Discussion:  Review and discuss an agenda for a management review meeting  (e.g. elements & measures)

 

·        Provide an example of how quality data might be trended and presented as part of a management review meeting

·        Review quality planning requirements and examine a simple quality plan

·        Outline QMS documentation structure

·        Provide examples of 483 observations from warning letters

·        Examine requirements for quality audits

·        Identify different types of audits and audit plan importance

·        Review internal audit questioning techniques and audit plan template

·        Provide examples of 483 observations from warning letters

 

Exercise:  Develop an audit plan for management responsibility using template provided

 

·        Examine personnel requirements

·        Discuss training programs within participants organizations and methods for assessment of training needs

·        Discuss importance of incorporating defect awareness into your training program and the affect/significance of such errors on finished devices

·        Provide examples of 483 observations from warning letters

·        Review FDA’s QSIT for Management Responsibility

 

III.            Analyze Design Control Requirements

 

·        Review design control applicability

·        Analyze design control requirements

·        Examine design and development planning elements

·        Present examples of design and development plans

·        Identify design input categories (e.g. Product Performance Specification)

 

Exercise:  Establish design inputs for a proposed device and expected design outputs using template provided

 

·        Review design output requirements

·        Define elements of a formal design review

·        Identify method for documenting design review meetings

·        Review verification and validation requirements

·        Compare design verification vs. design validation vs. process validation

 

Exercise:  Conduct a Design Review Meeting for the proposed device using template provided

 

·        Review key terms and definitions associated with risk analysis

·        Identify options for reducing risk

·        Discuss risk analysis tools

·        Review method for performing risk analysis and assigning risk

·        Review an example of a risk analysis using above method

 

Exercise:  Perform a risk analysis for a proposed device using template provided

 

·        Discuss design transfer requirements

·        Identify design change requirements

·        Identify Design History File elements

·        Provide examples of 483 observations from warning letters

·        Review FDA’s QSIT for Design Controls

 

IV.            Review Document Control, Purchasing Control, Identification and Traceability Requirements

 

·        Review document control requirements

·        Provide examples of 483 observations from warning letters

·        Review purchasing control requirements

·        Discuss methods for evaluating suppliers, subcontractors and consultants

·        Provide examples of 483 observations from warning letters

·        Review identification and traceability requirements

V.            Determine Production and Process Control Requirements

 

·        Outline production and process control elements

·        Discuss types of controls implemented to control production processes at participants organizations

·        Identify controls needed to ensure conformance with specifications

·        Outline steps for flowcharting a process

·        Provide an example of use of a process flowchart for a simple process

Exercise:  Develop a process flowchart for a simple process inclusive of required inputs and outputs

·        Identify requirements for production and process changes

·        Review additional production and process control requirements

·        Provide examples of 483 observations from warning letters

·        Review inspection, measuring, and test equipment requirements

·        Provide examples of 483 observations from warning letters

·        Review process validation requirements

·        Identify when process validation is needed

·        Review key validation terms and definitions

·        Identify validation protocol elements

·        Provide examples of 483 observations from warning letters

·        Review FDA’s QSIT for Production and Process Controls

 

 

VI.            Review Requirements for Acceptance Activities, Statistical Techniques, Nonconforming Product, and Corrective and Preventive Action

 

·        Review acceptance activity requirements at receiving, in-process and final inspection & testing

·        Identify finished device acceptance record requirements

·        Review acceptance status requirements

·        Provide examples of 483 observations from warning letters

·        Review statistical technique requirements

·        Provide examples of 483 observations from warning letters

·        Review non-conforming product control requirements

·        Provide examples of 483 observations from warning letters

·        Define correction vs. corrective action vs. preventive action

·       

·        Identify sources of quality data

·        Identify methods for collecting data and identifying/trending quality problems

·        Discuss root cause analysis

·        Determine root cause – interactive examples

·        Discuss practical tools used to determine cause(s) of quality problems

·        Determine corrective action – interactive examples

 

Exercise:  Use one of the methods discussed to identify the root cause(s) for a quality problem and determine corrective and preventive action(s) needed to prevent recurrence

 

·        Review corrective and preventive action requirements

·        Review FDA’s QSIT for Corrective and Preventive Action

·        Provide examples of 483 observations from warning letters

 

 

VII.            Analyze Requirements for Labeling, Packaging, Handling, Storage, Distribution, Installation and Servicing

 

·        Define label and labeling

·        Review labeling requirements for products

·        Discuss methods used for controlling labeling operations (e.g. line clearance)

·        Provide examples of 483 observations from warning letters

·        Review product packaging requirements

·        Provide examples of 483 observations from warning letters

·        Identify requirements for handling, storage, and distribution

·        Provide examples of 483 observations from warning letters

·        Identify requirements for installation

·        Provide examples of 483 observations from warning letters

·        Review servicing requirements

·        Identify service report elements

·        Provide examples of 483 observations from warning letters

 

 

VIII.            Determine QSR Record Requirements

 

·        Compare “document” vs. “record”

·        Review general record requirements

·        Define Device Master Record (DMR) components

·        Provide examples of 483 observations from warning letters

·        Identify Device History Record (DHR) requirements

·        Provide examples of 483 observations from warning letters

·        Define Quality System Record elements

·        Review definition of “complaint”

·        Discuss complaint reporting and record requirements

·        Review an example of a Product Complaint Reporting Form

·        Provide examples of 483 observations from warning letters

·        Discuss definition of “adverse event”

·        Discuss adverse event reporting requirements

·        Review product problem reporting requirements

·        Identify adverse event reporting forms and timeframes

·        Provide examples of adverse events from MED-WATCH reports

·        Provide examples of 483 observations from warning letters

 

 

X.            Miscellaneous

 

·        QSR section interrelationships

·        ISO Process Model

·        Establish and maintain procedures

·        “Where appropriate”

·        Review FDA enforcement activities and examples

·        Review FDA enforcement statistics

 

 

XI.            General Audit Expectations

 

·        What to expect from auditors and investigators

·        Typical questions