Course Description:

This two day interactive in-person seminar will inform and prepare firms on how to conduct Root Cause Analysis for Out-Of-Specification (OOS) investigations. During the seminar, attendees will learn the core skills and tools necessary to successfully conduct such investigations and obtain a clear understanding of the steps, techniques, and methods used to identify the root cause of problems.

This seminar will provide valuable problem-solving skills that you can immediately apply within your organization to conduct complete and thorough OOS investigation to meet FDA expectations. It will also provide some examples of cause mapping methods for solving issues into its cause-and-effect relationships and proper documentation for detail OOS investigations so that everyone asks the right questions and has accurate information. Several OOS exercises will also be presented during this seminar

Seminar instructor Richard Aleman is an ex-FDA official having more than 28 years of experience working with the FDA as an investigator, biologics specialist, compliance officer, associate director of import operations, director of investigations, and director of compliance.

Day one of the seminar will begin with a high level discussion why we need to know how to conduct Root Cause Analysis. The instructor will also provide:

  • A clear understanding of Root Cause and Root Cause Analysis
  • Steps, techniques, or methods used to identify the root cause of problems
  • Some examples of techniques and tools to use such as the use of Brainstorming and use of Fishbone diagrams
  • Specific questions to ask when performing Root Cause Analysis, and
  • Examples of Root Cause Maps as well as several root cause exercises

On day two, the instructor will focus on:

  • Out-Of-Specification (OOS) Investigations
  • FDA cGMP regulations regarding the handling of OOS results
  • FDA expectations of OOS investigations
  • Effectively handling OOS investigations, when to stop testing, and how to interpret tests results
  • Portions of The Barr Decision of 1993
  • The definition of Outlier Tests and Averaging of Test Results

Learning Objectives:

Attendees will learn how to:

  • Analyze problems thoroughly and effectively
  • Learn how to identify the root cause of a problem
  • Communicate complex issues visually and verbally
  • Take emotion, opinion and speculation out of problem solving
  • Develop a process/systems approach when managing problems within your operations
  • Anticipate problems to prevent them from occurring
  • Prioritize problems more efficiently and objective
  • Conduct complete and thorough OOS Investigations

If you were looking for answers to these questions, you would certainly benefit from attending this seminar:

  • Why do we need to know how to conduct root cause analysis?
  • What are some of the tools available to conduct successful root cause analysis?
  • How to apply the basics of identifying root cause and root cause analysis to become better problem solvers?
  • How to better define problems based on an organization's overall goals?
  • How to conduct structured, objective, evidence-based analysis for problem solving, and identify the best solutions for improving an organization's processes?
  • What are the FDA's expectations regarding complete OOS investigations?
  • How to understand and comply with the FDA requirement regarding OOS investigations?
  • How to protect your company against superficial and incomplete investigations?
  • Why are responses to FDA 483s and Warning Letters critical?
  • What are the steps for responding to FDA 483s and Warning Letter?

Who will Benefit:

This course will benefit personnel involved in quality or regulatory compliance for medical devices marketed in the European Union and it is ideal for quality, regulatory, and clinical professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.

Industries Positions/Titles:
  • FDA regulated Industries
  • Pharmaceuticals Manufacturers
  • Medical Device Manufacturers
  • Biotech Manufacturers
  • Supervisory/Middle Management
  • Subject Matter Experts (SME)
  • Quality Assurance/Management
  • Compliance Management
  • Warehouse Management Personnel

Course Outline:

Day One (8:30 AM - 5:00 PM) Day Two (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • Objectives of Training
  • Knowing the Steps, Techniques, or methods used to identify the root cause of problems
  • Benefits of Using Root Cause Analysis
  • Relationship between root cause and root cause Analysis
  • Philosophy of Root Cause Analysis
  • Principles of Root Cause Analysis
  • Goals of Using Root Cause Analysis
  • Tools Used in Root Cause Analysis
  • Questions to Ask When Performing Root Cause Analysis
  • Case studies and exercises

  • Definition of Out-Of-Specification (OOS)
  • Principles of OOS
  • Barr Decision (1993) Discussion
  • Key Point of Barr Decision
  • FDA Regulations Regarding OOS
  • Outlier Tests
  • Testing Into Compliance
  • Retesting/Resampling
  • Reprocessing/Reworking
  • Elements of a thorough investigation
  • FDA Expectations of OOS Investigations
  • Examples of FDA 483 Inspection Observations
  • Case studies and exercises

Meet Your Instructor

Richard Aleman, Ex- FDA Investigator
President - Quality Regulatory Compliance, Inc.

Richard Aleman began his career with FDA as an investigator in Dallas, TX in 1972 and held various positions in several field offices and headquarters including drug and biologics specialist, associate director of import operations, supervisor, director of investigations, and director of compliance until 2000. Mr. Aleman has 28 years of FDA experience and over 25 years of Supervisory/Management experience in the regulatory and enforcement areas, regarding FDA and international requirements and regulations, e.g. primarily managing Corrective and Preventive Actions, FDA 483 compliance corrections, responses to Warning Letter, etc., confronting the pharmaceutical, biologic, and medical device industries. He has conducted training, reviewed quality systems and provided guidance on quality, labeling and compliance issues.

As an investigator he conducted only the most complex and novel of assignments culminating in setting FDA legal precedence for one of his investigations. Mr. Aleman has significant experience in the auditing of pharmaceuticals, medical device, biologic, veterinary drugs, dietary supplement, imports, and food areas.

As a Supervisor, Director of Investigations, Compliance Officer, and Director of Compliance he managed through subordinates, Industry Consent Decree, and Warning Letters effecting the medical device, biologic, and pharmaceutical industries. He successfully completed numerous regulatory actions to bring firms and products into compliance. These actions included Warning Letters, Regulatory Letters, Seizures, Injunctions, Prosecutions, Inspection Warrants, License Suspension, License Revocations, working on grand jury investigations, and conducted a 305 hearing.

After leaving the FDA in 2000, Mr. Aleman worked with the regulated industry, including Adams Laboratories, where he was the director of compliance and instrumental in getting the approval of an NDA for the drug product, Mucinex. He was also the director of compliance for Cardinal Health and Vintage Pharmaceuticals in Huntsville, Alabama.

He began his career as a consultant in 2008, and he has worked extensively with the pharmaceutical, medical device, and dietary supplement industries to assist them in achieving compliance with the requirements of FDA laws and regulations. He served as the cGMP consultant and lead auditor for the United States Pharmacopoeia (USP) for four years, where he managed the auditing of USP’s Verification Program for Active Pharmaceutical Ingredients (APIs), Dietary Supplements, and Excipients.

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