This highly interactive two-day workshop brings together leading experts from FDA and industry to provide workshop attendees practical information and to help them develop working skills.  Presented by School@The Summit, the educational division of MedicalDeviceSummit.

The reviews from the conference evaluation forms rated this as an excellent program that was highly educational, providing practical and useful information.  With the recording you can see the powerpoint presentations and listen to the presenters speak

The recording is offered in seven 90 minute recordings.  With your purchase of the recording you will receive an email with the password on seven links to the individual recordings.  The price for the recording is $995.  Additional team members are $795.

Program background:  CAPA lies at the heart of a good Quality System. Recognizing that nothing is perfect and that there is always an opportunity for improvement, CAPA provides a method for collecting and analyzing information, identifying and investigating existing and potential product and quality problems, and taking appropriate, effective corrective and/or preventive actions. Used well, CAPA is a tool that also goes far beyond remediation and supports continuous product and business improvement.

CAPA is a key target of FDA scrutiny, consistently ranking at the top of the list of 483 observations and Quality System cites in warning letters. As Larry Spears of the CDRH Office of Compliance pointed out during a recent talk, CAPA is “a ‘pulse check’ for FDA on how well a firm’s Quality System is operating.” A strong CAPA system generally equates to a strong Quality System, while a weak CAPA system suggests fundamental and far-reaching organizational problems.

What you will learn: This program brought together leading experts from FDA and industry to provide workshop attendees practical information and to help them develop working skills on:

• FDA expectations and enforcement actions related to CAPA
• The recent GHTF final document on corrective and preventive actions
• The role of CAPA in the Quality System and its relationship to risk management
• CAPA as a business improvement driver
• When to open a CAPA
• Data sources for CAPA
• Conducting effective CAPA investigations and root cause analysis
• Potential regulatory and legal disclosure pitfalls of CAPA files
• Closing CAPAs
• Assessing CAPA effectiveness – doing a CAPA on your CAPA system
• raining on CAPA critical thinking skills
• Resourcing and coordinating CAPA across the organization

Speakers:

• Kimberly Trautman - Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH/FDA, and member of GHTF Study Group 3
• Sue Jacobs - Founder & President, QMS Consulting
• David Kouchoukos - Director, World Wide Quality Systems, Diabetes Care Franchise, Johnson & Johnson
• Pierre Boisier - Senior Vice President, Quality, Becton Dickinson
• Patricia Shrader - VP, Corporate Regulatory Affairs, Medtronic
• Ted Wilson - Partner, Hogan Lovells

Who should attend:

• Quality and regulatory professionals
• Manufacturing / Engineering / R&D managers
• Executives with management responsibility

Where:  Your desktop or conference room!

Agenda:

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Day 1



Recording 1
Welcome
Rick Biros - President and Publisher, MedicalDeviceSummit

CAPA – the Regulations and Rationale
Kimberly Trautman - Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH/FDA, and member of GHTF Study Group 3

• The purpose of corrective and preventive actions
• Challenges with medical device manufacturing
• CAPA and risk
• Origins and evolution of the QSR on CAPA
• The 2010 GHTF final document on corrective and preventive action and related QMS processes
• What regulators expect and what industry should expect
• Has CAPA gone astray?
• Enforcement trends and priorities
• Typical problems and challenges

Recording 2
Overview of the CAPA Process
Sue Jacobs - Founder & President, QMS Consulting

• Analysis and planning – 80% of the work
• Defining, evaluating, and limiting the problem
• Identifying processes and setting objectives
• Determining data sources
• Planning data collection and analysis
• Investigating the problem and finding the root cause
• Identifying, verifying, and implementing corrective and preventive actions
• Measuring active effectiveness
• Management review

When to Open a CAPA
Patricia Shrader - VP, Corporate Regulatory Affairs, Medtronic

• Identifying and defining the problem
• Applying risk management to CAPA decisions – setting action limits and thresholds
• Right-sizing the use of CAPA – what is too many or too few?
• Prioritization and resource allocation
• When a CAPA is not needed
• Making and justifying consistent CAPA decisions

Recording 3
Data Sources for CAPA
Pierre Boisier - Senior Vice President, Quality, Becton Dickinson

• Complaints, MDRs, nonconformances, service reports, and other inputs
• Organization and information flow

Breakout Exercise: Case Study on CAPA
Sue Jacobs and Faculty



Recording 4
Investigating the Problem
Kouchoukos - Director, MD&D Quality Systems, Johnson & Johnson Quality and Compliance

• Avoiding “scope creep” – keeping focused
• The role of the CAPA owner
• Root cause analysis procedures and tools
• Monitoring the investigation
• Documenting the investigation
• Aging CAPAs and what to do about them
• Management escalation and management review

Legal Considerations and Concerns
Ted Wilson - Partner, Hogan Lovells
The importance of complete, contemporaneous documentation of CAPAs
Decisions to conduct (or not conduct) field actions associated with CAPAs
Points to consider in documenting root cause investigations
Balancing FDA’s policy not to request management review, quality audit, and supplier audit records with the policy to request related CAPAs
Compliance without unwanted exposure

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Day 2

Recording 5
Future-proof your CAPA process, (Sponsor Presentation)
 Tim Mohn, Industry Specialist, Sparta Systems

• Companies are constantly changing, whether via centralization of existing processes or Mergers & Acquisitions
• Best-practices for implementing and maintaining a Quality System strategy in a changing environment
• Case studies of real-life lessons learned at device companies

Standardization across Multiple Sites & CAPA Training
David Kouchoukos - Director, World Wide Quality Systems, Diabetes Care Franchise, Johnson & Johnson

• Designing and implementing a standardized CAPA process across divisions, sites, and business units
• Case study of a process in progress across 40 – 50 sites
• Training on CAPA – teaching critical thinking

Recording 6
CAPA Documentation and the Benefits and Risks of CAPA Automation
Pierre Boisier - Senior VP, Quality, Becton Dickinson

• Best practices in tracking and documenting CAPAs
• The uses and illusions of automated CAPA systems – how they can help and when they accelerate mistakes

Recording 7
Making CAPA a Business Improvement Driver
David Kouchoukos - Director, World Wide Quality Systems, Diabetes Care Franchise, Johnson & Johnson

• Drive customer value
• Enhance management review
• Reduce compliance risk
• Lower cost
• Serve as repository of product improvements

Closing CAPAs
Sue Jacobs - Founder & President, QMS Consulting
When is a CAPA closed?
When should CAPAs not be closed, and what do you do with lingering open CAPAs?


Doing a CAPA on your CAPA System
Pierre Boisier - Senior VP, Quality, Becton Dickinson

• Creating a positive CAPA culture
• Effectiveness checks on your CAPA procedures
• Documenting the process and telling the story
• Measuring outcomes and making improvements – closing the circle on CAPA