FDA Audit


Achieve Deficiency-Free Operations and Drive Continuous Improvement by Mastering the Complete Investigation Process 

OOS investigations pose a significant challenge in the pharmaceutical industry, often resulting in warning letters due to deficiencies. FDA regulations mandate thorough investigations of out-of-specification (OOS) results, making well-documented and compliant quality management systems essential. However, many companies struggle with understanding the regulatory expectations and proper handling of OOS and OOT (out-of-trend) cases. Inconsistent investigation and root-cause analysis processes can lead to errors and costly laboratory activities. This informative series provides comprehensive insights into best practices for OOS/OOT investigations.

The first session delves into the FDA Guidance for Industry on OOS/OOT investigation, offering a detailed understanding of the process. Discover how to differentiate between measurement and manufacturing causes when an OOS value is detected.

Learn essential techniques for conducting root-cause analysis and implementing necessary corrective and preventive actions. Gain insights into the critical role of testing in determining the cause of OOS results. The second session explores OOT scenarios, addressing both stable and changed properties of drug products to establish trend monitoring and product profile maintenance. Learn how to perform risk assessments to identify critical quality attributes and collaborate with cross-functional teams for continuous product improvement. In the third session, the focus shifts to documentation, a common cause of Warning Letters in OOS investigations. Gain valuable knowledge on designing investigation plans, setting acceptance criteria, defining timelines, and assigning responsibilities. Additionally, understand the essential components of a comprehensive investigation report.

The series concludes with a session addressing deficiencies in this area, emphasizing the importance of CAPA (Corrective and Preventive Actions) and the necessity of building ruggedness into analytical procedures to prevent OOS occurrences. Explore performance metrics and key performance indicators to evaluate system performance effectively. In summary, this series provides analysts with a comprehensive understanding of the investigation process, up-to-date regulatory requirements, and strategies for monitoring OOS and OOT cases to continually enhance product performance.


DAY 1 (10 AM to 3 PM) 
DAY 2 (10 AM to 3 PM) 

Lecture 1: Identification of Out-of-Specification (OOS) and the Investigation Process - A Comprehensive Review of the FDA Guidance and Requirements
  • Identifying and assessing OOS test results
  • Phase I: Laboratory Investigation
  • Phase II: Full Scale OOS Investigation
  • Identify root causes
  • CAPA and follow up

Lecture 2: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
  • Recognize different types of OOT results
  • Establish trend for release and stability data
  • Understand risk assessments to determine Critical Quality Attribute (CQA)
  • Determine course of actions to process
  • Understand cross-functional investigation
  • Monitoring product trends to avoid OOS

Lecture 3: Developing Investigation Plans and Writing Investigation Reports
  • Design a systematic investigation plan
  • Determine root causes
  • Establish acceptance criteria for investigation
  • Components of an investigation report
  • Timelines and responsibilities
  • Establish Corrective Actions and Preventive Actions
Lecture 4: Laboratory Deficiencies and How to Minimize OOS/OOT
  • Review regulatory deficiencies to establish investigation process
  • Build ruggedness into the analytical procedures to prevent OOS occurrences
  • Build compliance into the investigation process to minimize OOS
  • Determine Key Performance Indicators (KPI) to monitor process
  • Establish documentation and performance metrics

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research & Development Departments
  • Regulatory Affairs Departments
  • Validation Professionals
  • Auditors
  • Analysts
  • Lab Supervisors and Managers
  • Documentation Professionals
  • Consultants
  • Contract Laboratories Professionals
  • CROs
Read more