Thursday September 2, 2010
Root Cause Analysis (RCA) & Corrective and Preventive Action (CAPA)
A Comprehensive Two-day Interactive Course & Workshops ~ Strategies for an Effective Root Cause Analysis and a Robust CAPA System
August 20-21, 2009 | Montreal, Canada

A two-day Interactive Course & Workshops Featuring:

  • Regulatory Perspective
  • Identifying RCA by using a Flow-Chart
  • Investigational Tools – FMEA (Failure Mode and Effects Analysis), Fault Tree Analysis
  • Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
  • Essential SOPs and Other Documentation
  • Root cause investigations
  • Tracking and Trending Application and using effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
  • Identifying and tracking deviations and non-conformances
  • Connecting Issue Review, Cause Analysis and Problem Prevention
  • Outlining the requirements of the CAPA process and procedure including building a CAPA file.
  • Definition of the essential elements of the CAPA file and their intended purpose
  • Preparing CAPA SOPs & Reports
  • Establishing a CAPA plan: project definition, individual responsibilities and expected completion dates.
  • Documentation for root cause analysis in the CAPA file.
  • QSR and ISO 13485 requirements for CAPA
  • Elements of a successful CAPA system
  • Practical Problem Solving Process
  • CAPA Process Summary

Course Overview:

Root Cause Analysis (RCA) is a valuable tool for reliability improvement in manufacturing and production operations. Yet, most efforts to implement an RCA program fail to achieve meaningful results despite significant investments in employee training. Root Cause Analysis is currently one of the most underutilized reliability and quality improvement tools available for organizations seeking to eliminate failures and reduce manufacturing costs. Virtually all manufacturing organizations can benefit from having an effective RCA program.

During this two-day course and workshop, our industry experts will examine the process of root cause analysis, including the application of systematic methods for identifying primary root causes as well as possible contributing factors. They will also provide several root cause analysis tools to enhance the attendees problem solving.

You will learn how to identify and use effective Root cause analysis tools in order to develop and document effective problem solutions to ensure that you target CAPA (corrective action and preventive action) efforts at the points of most leverage, as well as in pointing change management efforts in the right direction. You will also learn what needs to be done to assure that RCA becomes a functional work process in your organizations.

This two day intensive program will provide an understanding of the principles and techniques involved in the practice of Root Cause Analysis with emphasis on the practical aspects of how to perform an analysis. In addition, extensive workshops will provide effective methods which can be used with a Corrective Action system to helps attendees to ensure costly issues are resolved quickly and do not get dropped through the cracks.

The course will provide attendees with a system to categorize all types of issues assign responsibility and track team activities to resolve important issues and prepare templates to capture all needed data to comply with CAPA reports.

Attendees will also learn skills in problem prevention, the identification of the characteristics and changes that have contributed to simple and complex problems and how to fix them. The goal of this course is to provide participants from industry, academia, and regulatory agencies an opportunity to share experiences, learn from each other, and identify issues for future discussions or workshops. In our unique Panel Sessions you will have the opportunity to put your questions and comments to our expert speakers. Guide the direction of the discussion to meet your course needs.

Mr. David A. Baldwin
Vice President of Eastern Operations
PathWise, Inc.

Dave Baldwin is currently the Vice President of Eastern Operations for PathWise, Inc. which is based in Orem, Utah. Until his recent retirement, he was the Manager of Management Training and Development for the Hospital Products Division, Abbott Laboratories.

For more than 25 years, he has worked with hundreds of government and private organizations in the areas of Root Cause Investigations, Risk management, leadership training, motivation, team building, employee selections, and organizational development.

Dave has served as consultant and trainer as a member of the Department of Defense Organizational Effectiveness Institute, the McDonnell Douglas Management Institute as well as the private sector.

During his career, Dave has worked with and has been certified by many of the major training companies in the United States. His experience far exceeds training and his in-depth knowledge brings a new insight to client companies in the areas of organizational performance, systems alignment, and employee development.

As a leader in training and development for Abbott Laboratories, Dave developed organization-wide learning strategies, self-directed work teams in production plants and has introduced “ZAPP: The Lightening of Empowerment” to the Hospital Products Division. Hospital and hospital group customers request Dave speak on the subjects of empowerment, strategic planning, and culture change in the medical setting.

Dave brings with him the knowledge and experience of two plant start-ups along with transformations to employee involvement in four existing plants.

He earned his Bachelor’s degree in Business Management from the University of Maryland and a Master’s degree in Management and Organization Development from Webster University in St. Louis.

Mr. Tom Weaver
President
Weaver Consulting, LLC

Mr. Weaver is a quality and operations improvement consultant whose expertise includes strategic planning, quality and operations improvement, root cause investigation, design control, and project management. Prior to starting his own consulting business, Mr. Weaver had a 28 year career with Baxter Healthcare with management positions in the Manufacturing, R&D, and Quality functions, leading Total Quality Management and Six Sigma processes. Having initiated and launched the Baxter Quality Institute as an educational and skill building branch of the Quality function, Tom designed and provided multi-disciplinary quality and regulatory training programs. Built upon the Six Sigma concepts, Tom directed Quality Technologies offering advanced, statistically-based improvement tools for engineers and scientists. He retired in 2003 as the Vice President, Quality Management, leading its Total Quality Management and Six Sigma processes. He founded Weaver Consulting in 2003 which today provides services to clients globally. Mr. Weaver holds a Bachelor of Science Degree from the United States Military Academy at West Point, NY.

Day 1 - Thursday, August 20th, 2009
8:00 AM - 8:30 AM - Registration and Continental Breakfast
8:30 AM - 10:15 AM - Root Cause Analysis (RCA) - Regulatory Expectations for pharmaceutical, biologics and medical device industries
  • Health Canada & FDA Expectations for Investigations
  • RCA and CAPA Review of key investigation elements
  • 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

  • Understanding Failures, Exceptions and Non-conformances
  • Gathering, organizing and managing the data required to conduct meaningful RCA and carry out comprehensive investigations
  • Methods of Determining Root Causes
  • Common categories of root causes and contributing causes
  • Analyzing common causes of non-compliance, failures, deviations, complaints
  • FDA Warning Letters & Common 483’s
  • 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 - 12:30 AM - Effective Steps and Techniques to conduct Root Cause Analysis (RCA)
  • Introduction
    • Situation: A change in Performance
    • Course objectives
    • Introduction to the 7-step investigational methodology
    • Introduce the case study
  • Step 1: Define the Performance Problem
    • Describe the problem
    • Workshop: Describe the problem
    • Describe the process(es)
  • Identify the process inputs
  • Step 2: Collect Data
    • What data to collect
  • Workshop: Collect data
12:30 PM - 1:45 PM - Luncheon
1:45 PM - 3:15 PM - Effective Steps and Techniques to conduct Root Cause Analysis (RCA) Continue
  • Step 3: Identify Possible Causes
    • Time line of changes
    • Searching for differences
    • Workshop: Searching for differences
    • Reviewing the risk analysis
    • Cause & effect diagram
    • Workshop: Identifying possible causes
  • Step 4: Test Possible Causes
    • Testing technique

Workshop: Test possible cause

3:15 PM - 3:30 PM - Mid-Afternoon Refreshment
3:30 PM - 5:15 PM - Effective Steps and Techniques to conduct Root Cause Analysis (RCA) Continue
  • Step 5: Identify Root Cause
    • Validate assumptions
    • Conduct experiments
  • Step 6: Determine Best Solution
    • Mistake proofing
    • Variation reduction
    • Workshop: Determine best solution
  • Step 7: Verify Solution

The Case of the Aberrant Sterilizer

5:15 PM - 5:30 PM - Question & Answer
Day 2 - Friday August 21st, 2009
8:00 AM - 8:30 AM - Continental Breakfast
8:30 AM - 10:00 AM - Corrective and Preventive Action (CAPA) & Current Regulatory Enforcement Trends
  • Quality System Regulation, 21 CFR Part 820
  • CAPA and Quality System Inspection Technique (QSIT)
  • FDA Warning Letters and Common 483s
  • How to prevent recurrence of nonconforming product and other quality problems (Corrective How to eliminate the cause of potential nonconforming product and other quality problems (Preventative Action)
10:00 AM - 10:15 AM - Mid-Morning Refreshment Break
10:15 AM - 12:30 PM - CAPA Procedures
  • Identification – clearly define the problem
  • Evaluation – appraise the magnitude and impact
  • Investigation – make a plan to research the problem
  • Analysis – perform a thorough assessment
  • Action Plan – create a list of required tasks
  • Implementation – execute the action plan
  • Follow Up – verify and assess the effectiveness
  • Closure –documentation
  • Effective Techniques for Data Analysis

Optimizing CAPA Documentation Procedures

  • Writing effective SOPs
  • Assigning responsibilities to ensure RCA and CAPA issues are handled in a timely manner
  • Maintaining accurate RCA and CAPA documentation using proper procedures
  • Outline the databases, logs and computer systems used in a CAPA program
  • Revisit how to keep adequate routine reports and establish a good audit trail

Validating Effectiveness of Corrective and Preventive Actions

  • Determine if the corrective and preventive actions were effective
  • Verify and validate the CAPA program
  • Handle and report OOS results
  • Track changes in CAPA
  • Confirm that the corrective actions did not affect the product or system

Confirm closure of CAPAs

12:30 PM - 1:45 PM - Luncheon
1:45 PM - 3:15 PM - 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
  • 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
3:15 PM - Conclusino of the Program

This 2-day course and workshops is directed toward Directors, Managers, Supervisors, and Associates in the Pharmaceutical, Biopharmaceutical, 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
  • New product development
  • Analytical Laboratory
  • CAPA Coordinators
  • Auditing
  • Consultants
  • Engineering
  • Clinical research
  • Product Submission
  • Validation
  • Training
  • Documentation
  • Production
  • Engineering
  • Facility Monitoring
  • Contract manufacturing

Take advantage of this unique opportunity to participate in a shared learning environment and find expert solutions

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Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/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 $210.00 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.

Hilton Garden Inn
Montreal Airport
7880 Côte de Liesse St. Laurent,
Montreal, Quebec, Canada H4T 1E7

For reservation please contact:
Mary Korakianitis
Tel: 514-788-5034 or 1-866-788-2518
Email: Mary.korakianitis@hilton.com

http://hiltongardendorval.com/

A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention International Pharmaceutical Academy to receive the reduced room rate.

For more information, please call us at 416-410-7402 or enquiry@ipacanada.com
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