Conducting Effective Root Cause Analysis (RCA)
and Corrective and Preventive Action (CAPA)
for Pharmaceutical & Medical Devices
A TWO DAY COMPREHENSIVE & INTERACTIVE COURSE,
CASE STUDIES, & WORKSHOPS ON:
- Regulatory Expectations for RCA and CAPA
- Common Categories of Root Causes and Contributing
Causes
- Responding to Non-Compliance, Failures, Deviations,
Complaints
- Effective Steps for Conducting Root Cause
Analysis
- How to Review your Quality Data
- Selecting and Using Problem Solving, Investigation
and Measuring Tools
- Performing Trend Analysis and Fault Tree
Analysis
- Utilizing the 5 Why’s, Fishbone, Flow Charting
- Identifying the Extent of Product or Quality
Problems
- Utilizing CAPA and Monitoring your Quality
System
- Measuring, Monitoring, and Confirmation Activities
- Designing and Implementing a CAPA Program
- Oganizational Aspects of CAPA
- Analyzing Objectives to Identify Potential
Problems
- Developing Essential SOP’s and Training Plans
- Preparing Documentation for Inspections
- Consequences of CAPA Failures
- Validation of Corrective and Preventive Actions
Program
Case Study Disucssions and Interactive Activities
- Strategies for Information and Data Gathering
- Implementing and Conducting a CAPA Review
Board Meeting
- Reviewing 483 Observations and Determining
Proper CAPA documentation
Distinguished Course Leaders
 
Mr. Alan Schwartz
Executive VP
mdi Consultants, Inc.
Alan Schwartz began his career as an FDA investigator
in 1972. He rose to the position of supervisor
of field operation prior to leaving the FDA
in 1978 to start his consulting career. Alan
has implemented over 75 quality systems and
led over 100 companies successfully through
FDA audits and ISO certification. Alan has trained
over 12,000 individuals in cGMP. Mr. Schwartz
has over 50 articles published on Quality Assurance
and Regulatory Affairs and is a member of the
industry group that defined HACCP regulations.
He is a Certified Lead Assessor and has been
Executive Vice President of mdi since 1994.
Ms. Diane G. Kulisek President
CAPAtrak LLC
Diane Kulisek has over 30 years of practical
experience within the Quality profession and
is President of CAPAtrak, LLC,
a contract provider of quality assurance and
regulatory compliance leadership, services and
solutions. She has held key management positions
within the consumer products, aerospace and
biomedical industries, most recently as Vice
President of Quality and Regulatory Affairs
for Spectrum Laboratories. Her career has included
8 years within the Gillette Company, with a
final position as Manager of Quality Engineering
and the Product Development Laboratory at Gillette’s
Santa Monica Manufacturing Center and 9 years
within Rockwell International, culminating with
her role as Associate Product Manager for Avionics
& Controls on NASA’s Space Shuttle Main
Engine Program.
Diane is currently Chair-Elect for the Food,
Drug and Cosmetic Division of the American Society
for Quality (ASQ) and Quality Advocacy Chair
for the San Fernando Valley Section of ASQ in
Southern California. She has been a Member of
ASQ for over 25 years and is a Senior Member,
as a Certified Manager of Quality/Organizational
Excellence and as a Certified Quality Engineer.
Ms. Kulisek holds a Bachelor’s Degree in Biology,
a Master of Science in Engineering Management
and Graduate Certificates in Environmental Planning
and in Program Management.
Program Agenda
| Day 1 |
Wednesday ,June 18th,
2008 |
| 8:00 AM - 8:30 AM |
Registration and
Continental Breakfast |
| 8:30 AM - 10:15 AM |
Regulatory Expectations
and Guidance
- Health Canada & FDA Expectations
for Investigations
- RCA CAPA in pharmaceutical, biologics
and medical device industries
- Analysis and Investigation Requirements
in the CAPA System
- ISO13485 CAPA requirements
- The Role of RCA CAPA in Today’s Risk
Based
- Quality System Regulation, 21 CFR Part
820
- CAPA and Quality System Inspection
Technique (QSIT)
- RCA CAPA and PAT
- Review of FDA Warning Letters &
Common 483’s
- Case Study Discussion
Determining When a Root Cause Analysis
is Necessary
- Defining Failures, Exceptions and Non-conformances
- Common categories of root causes and
contributing causes
- Analyzing common causes of non-compliance,
failures, deviations, complaints
- Responding to non-compliance, failures,
deviations, complaints
- Review of key investigation elements
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12:00 PM |
Effective Steps and
Techniques to conduct Root Cause Analysis
- Methods of Determining Root Causes
- Understand the basics of root cause
analysis
- How to identify and investigate product
and quality problems
- Roles and Responsibilities in Conducting
Investigations
- How to avoid common errors in root
cause analysis
- Gathering, organizing and managing
the data required to conduct comprehensive
investigations
- Selecting Problem Solving and Measuring
Tools
- Importance of tracking and trending
“document and correct” errors
- How to document investigation results
and recommendations
Case Study Discussion
|
| 12:00 PM - 1:15 PM |
Luncheon |
| 1:15 PM - 2:45 PM |
Corrective and Preventive
Action (CAPA)
- Differentiation between Corrective,
Preventive, and Remedial Actions
- Following CAPA Procedures
- Identification
- Evaluation
- Investigation
- Analysis
- Action Plan
- Implementation
- Follow Up
- Closure
- Problem Definition and Data Collection
- List the sources of data involved in
a CAPA program
- Identify the extent of product or quality
problems
- Determine whether or not a complaint
should go through a CAPA program
- Documentation, Records, and Tools
- Training Requirements
Case Study Discussion
|
| 2:45 PM - 3:00 PM |
Mid-Afternoon Refreshment |
| 3:00 PM - 4:30 PM |
Workshop: Group Activity
Using CAPA to Get the Most Value
- How do you review your quality data?
- What does CAPA have to do with monitoring
your quality system?
- Conducting quality trending
Strategies for Information and Data Gathering
- Investigational Tools
- Trend Analysis and Fault Tree Analysis
- Histograms, Charts and Plots
Investigational Tools
- 5 Whys Technique
- Force Field Analysis
- Cause and Effect (Fishbone) Diagram
|
| 4:30 PM - 4:45 PM |
Questions & Answers |
| 4:45 PM |
Conclusion of Day
One |
|
|
| Day 2 |
Thursday, June 19th,
2008 |
| 8:00 AM - 8:30 AM |
Continental Breakfast |
| 8:30 AM - 10:15 AM |
CAPA Process Summary
and Follow-ups
- Closing the Investigation
- Reviewing the problem solving process
- Measuring effectiveness of the Corrective
and Preventive action
- Evaluating Risk and Effectiveness of
Corrective Action
- Conducting an After Action Review (AAR)
- Determining the effect of the CAPA
on your system or product
- Verifying / Validating CAPA
- Change Control
- Selecting items that need continuous
tracking and monitoring
- Continuous Improvement
- Links with Internal Audit Program,
Systemic Issues
- Management Review Systems
- Communicating and Reporting to Management
Interactive Discussion:
How to Manage FDA’s Questions about your
CAPA
- What is FDA keying into during inspections?
- What should you be prepared to give
FDA concerning CAPA?
- Preparing Documentation for Inspection
- Trend analysis
- Internal audits
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12:00 PM |
Workshop B: Interactive
Session
Reviewing 483 Observations and Determining
Proper CAPA documentation |
| 12:00 PM - 1:00 PM |
Luncheon |
| 1:00 PM - 2:45 PM |
Workshop C: Case
Study and Interactive Session
Implementing and Conducting a Corrective
and Preventive Action Review Board Meeting |
| 2:45 PM - 3:00 PM |
Questions and Answers |
| 3:00 PM |
Conclusion of Program |
|
|
Who Should Attend?
This two day course and workshops is directed
toward Directors, Managers, Supervisors, and Associates
in the Pharmaceutical, Medical Device, and allied
industries with daily responsibilities in the
following areas:
- Quality Assurance
- Quality Control
- Change Control
- CAPA Management
- GMP/GLP Compliance
- Regulatory Affairs
- R&D
- Product Submission
- Validation
- Training
- Documentation
- Production
- Engineering
- Facility Monitoring
- Contract manufacturing
Registration Information:
Registration Fee: $825.00 +
GST
Online Registration
Payment Information Course
Location & Hotel Accommodations
Registration Fee Includes:
Presentation Materials, Luncheon and RefreshmentsCancellation/Substitutions Policy:
CANCELLATION POLICY: Cancellation is accepted in writing (by mail, or fax) up to 4 weeks before the program start date, after which cancellations are not accepted and do not qualify for refund or credit. All Cancellations are subject to a $212.00 CAD (incl. GST)/person processing fee. Substitution of delegate/s with the member/s of the same organization is permitted at any time. IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.
Certificate of Attendance:
All participants will receive a certificate of attendance upon completion of the course
For registration or any further information, please contact us at:
Tel: (416) 410-7402
Fax: (416) 491-5810
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