CAPA and its Strategy: Root Cause Analysis: 2-day In-person Seminar

By: Les Schnoll, Principal of Quality Docs, LLC
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Course Description:

  • Are you in compliance with the FDA Corrective and Preventive Action (CAPA) requirements for medical devices?
  • Do you know how to identify root cause?

The cost of regulatory noncompliance remediation is significantly greater than the cost of compliance.

By attending this two day intensive seminar on CAPA, participants will:

  • Gain detailed knowledge of CAPA.
  • Learn how to ensure that their CAPA process is adequate and effective.
  • Understand and implement proven methods of problem solving to identify root causes.
  • Learn proven, thorough, and efficient methods of problem solving to improve the performance of their current system and ensure regulatory compliance.

This program will include a “pre-test” to be reviewed on Day 1 of the program and a “homework” assignment to be completed on the evening of Day 1.

Learning Objectives:

Upon completing this course participants will:

  • Understand both corrective and preventive actions: definitions, differences, similarities
  • Understand how FDA inspects CAPA
  • Create a “closed loop” CAPA program
  • Learn root cause analysis through the use of problem-solving tools and methodologies
  • Evaluate the effectiveness, suitability, and adaptability of implemented solutions/corrective actions
  • Understand where an issue can be localized or must be evaluated for systemic effect
  • Prioritize using risk assessment methodologies
  • Understand where companies miss the mark in triggering, investigating, and executing CAPAs

Who will Benefit:

This course is designed for personnel responsible for performing, maintaining, and improving the organization’s CAPA program in compliance with 21 CFR 820.100 (Subpart J – Corrective and Preventive Action). The following personnel will benefit from the course:

  • Quality Managers and Professionals
  • Regulatory Managers and Professionals
  • Compliance Managers and Professionals
  • Production Management
  • Manufacturing Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Document Control Personnel
  • Legal Professionals

Topic Background:

Since 2010, the FDA’s findings of medical device manufacturers Quality System Regulation (QSR) deficiencies have shown that Corrective and Preventive Action (CAPA), one of the seven subsystems under the Quality System Inspection Technique (QSIT) methodology is by far the most prevalent, accounting for almost one-third of cited violations; a significant number of those citations have led to the issuance of Warning Letters. The expectation of the FDA is the identification of the root cause leading to the issue, its effective elimination, and monitoring to ensure that the actions taken were effective.

The average cost of a Warning Letter remediation effort is estimated at $750,000 to correct the identified deficiencies and includes additional resources for consultants, personnel, remediation of legacy records, etc. This cost estimate does not even include the ramifications of product recalls or holds, cost of not going to market with a new device, or delays in FDA 510(k) or PMA processing as a result of a Warning Letter, and poor publicity.

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM


Corrective and Preventive Action

  • CAPA Overview
  • Corrective Action
  • Preventive Action
  • The “Closed Loop” System
  • CAPA Warning Letters
  • The Need for Systemic Evaluation

Problem Solving and Root Cause Analysis

  • Problem Solving Pre-Work Review
  • Problem Solving Overview
  • Step 1: Identify the Problem
  • Step 2: Identify the Team
  • Step 3: Contain the Problem
  • Step 4: Describe the Problem

Day Two (8:30 AM – 04:30 PM)

Problem Solving and Root Cause Analysis (continued)

  • Step 5: Identify Possible Causes
  • Step 6: Verify Root Cause
  • Step 7: Implement Corrective/Preventive Action
  • Step 8: Measure and Monitor Results
  • Use of a Decision Matrix
  • Course Review and Wrap-Up

Meet Your Instructor

Les-Schnoll-90X112
Les Schnoll
Principal of Quality Docs, LLC.

Les Schnoll has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. Mr. Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.

Les is the Principal of Quality Docs, LLC, providing quality and regulatory services to the FDA-regulated and Arizona Department of Health-regulated industries. He is also currently an Instructor in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Device program in the College of Professional Studies at Northeastern University and a Faculty Associate at Arizona State University, College of Nursing and Health Innovation, in the MS Regulatory Science and Health Safety Program. He was most recently the Vice President, Quality Assurance and Regulatory Affairs with the J.T. Posey Company and has held executive positions at ThermoGenesis, Theravance, Solectron, Hill-Rom, Gliatech, Cyberonics, Southern Research Institute, KPMG Quality Registrar, and Dow Corning Corporation. Les has conducted various training programs, audits, and systems development in the United States, Canada, Europe, South America, Russia, Australia, and the Pacific Rim.

Les has written articles for such publications as Medical Design and Material, ISO 9000 Handbook of Quality Standards and Compliance, Pharmaceutical and Medical Packaging News, Food Quality, and Quality Progress. He is also the author of The CE Mark: Understanding the Medical Device Directives and The Regulatory Compliance Almanac, published by Paton Press.

Les professional affiliations include the American Society for Quality as a Certified Quality Engineer, Certified Quality Auditor, and Certified Quality Manager; the Regulatory Affairs Professionals Society as Regulatory Affairs Certified; the Institute of Certified Quality Consultants as a Certified Quality Consultant; the American Society for Microbiology as a Registered Microbiologist (clinical microbiology) and Specialist Microbiologist (consumer and industrial microbiology); and the International Register of Certified Auditors as a certified lead assessor. He is a Fellow of the Chartered Quality Institute (formerly the Institute of Quality Assurance) and is accredited as a Chartered Quality Professional. Schnoll is also a former member of the United States Technical Advisory Group to Technical Committee 176, International Organization for Standardization and the United States Technical Advisory Group to Technical Committee 210, International Organization for Standardization.

Les has a Bachelor of Science degree in biology from Ursinus College, a Master of Science degree in microbiology from Villanova University, a Master of Business Administration in human resources from Central Michigan University, and a Juris Doctor in health law from Concord University School of Law.

Venue

Location:
Grand Hyatt San Francisco
345 Stockton Street,
San Francisco, California, USA, 94108

August 14-15, 2014

Special Offer for the attendees of this seminar:

Rooms available at 15% discount and with free internet.

Use the code "CR88975" at the time of booking to avail of this offer.

Please note: Hotel rooms are limited and based on availability.



How to Reach

General Driving Directions:

From San Francisco International Airport: 14 miles
  • Take 101 North toward the San Francisco and Bay Bridge.(Cambridge)
  • Exit 280 North toward "Port of SF/280 North". Stay in left lane and 280 becomes King Street.
  • At 2nd light, turn left onto 3rd St and go 8 blocks to Market St.
  • Cross over Market St. (which becomes Kearny St.) and continue 2 blocks.
  • Turn left on Sutter St. Go 2 blocks to Stockton and the hotel is located on the left corner.

From Oakland Airport: 20 miles
  • Take 880 North toward San Francisco and cross over on the Bay Bridge.
  • Take the Fremont St. Exit (on right) & proceed 1/2-block on Fremont St.
  • Turn left onto Howard St & Turn right onto 3rd St.
  • Cross Market St. (Street changes to Kearny).
  • Take Kearny 2 blocks to Sutter St. and turn left.
  • Take Sutter St. to Stockton St. and turn left.

From San Jose International Airport: 46 miles
  • Take 101 North toward San Francisco for approximately 43 miles
  • Take I-80 East toward Bay Bridge/Oakland.
  • Exit at Fourth Street toward Embarcadero.
  • Make a slight left onto Bryant Street.
  • Then a left onto Third Street & Third Street will become Kearny Street.
  • Take Kearny 2 blocks to Sutter St. and turn left.
  • Take Sutter St. to Stockton St. and turn left to reach the Hotel.
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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