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Sustainable Compliance for Out of Specifications (OOS) Results, Deviations, and Corrective and Preventive Actions (CAPA)

By:
Rajesh K Gupta, Visionary Scientific and Compliance Consultant, Biologics Quality & Regulatory Consultants, LLC
Coming soon.. Please contact customer care for new schedule

Course Description:

This seminar will be taught by Former Deputy Director and the Lab Chief in the Division of Biological Standards and Quality Control, FDA/CBER.

Throughout the course, specific examples with regard to achieving regulatory compliance during inspections and audits will be discussed. More importantly, the seminar will focus on understanding data of exception, including OOS, their impact on quality, finding a root cause in order to develop robust and effective CAPA procedures to achieve sustainable compliance.

The course will start with an introduction to roles and responsibilities of QC Unit with an overview of Laboratory QMS, then focusing on key quality systems or issues, such as data of exceptions, including out of specifications (OOS), and Corrective and Preventive Actions (CAPA).

In this seminar:

- historical aspects of OOS and understanding of the stigma associated with OOS will be presented in order to mitigate the risk for OOS. A thorough investigation procedure into OOS results following the FDA Guidance will be discussed with an aim to finding a root cause for the OOS. Challenges in Investigating OOS results for Microbiology testing will also be presented. Ways to avoid OOS risk will be discussed.

- will discuss the data of exceptions during manufacturing operations and performing investigations into these observations using a structured approach with the objective of determining the root cause. The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9 guidelines. Ways to implement corrections, corrective actions and preventive actions and a follow-up to monitor effectiveness and sustainability of these procedures will be described.

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar



Learning Objectives:

Upon completing this course the participants will understand:

  • Role and Responsibilities of Quality Control Unit with regard to assuring manufacture of quality products consistently and to achieve sustainable compliance during laboratory operations
  • Laboratory Quality Management Systems and their role in QC operations
  • Data of Exceptions – Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trend (OOT), Out of Frequency (OOF)
  • Managing Data of Exceptions
  • Biological Deviations
  • Regulations, History, Background and Importance of OOS
  • Uncertainty of Methods & Re-testing
  • Re-test and Investigative Testing during OOS investigation
  • Issues with Testing into Compliance
  • Reportable Results and Averaging of Data
  • OOS investigations for Microbiological data
  • OOS Investigation – Phase I Investigation, Phase II Investigation
  • Re-testing, Re-Sampling, Outlier Tests
  • Root Cause Analysis for Investigations from Deviations, Non-Conformances, OOS, OOT, OOF
  • Correction, Corrective Actions and Preventive Actions
  • Effectiveness and Sustainability of CAPA


Who Will Benefit:

  • Pharmaceutical Industry
  • Biotech Industry
  • Managers and Scientists involved in Drug Development
  • Analytical Development Managers and Scientists
  • Quality Control Managers and Scientists
  • Quality Assurance Staff for Informed Review of Data and for Managing and Providing Oversights on data integrity, Investigations, CAPA, etc.
  • Senior Management and Corporate Team


Topic Background:

Quality Control (QC) Unit plays a critical role in assuring the identity, strength, quality, purity, and stability of drugs and biologics. QC Unit is responsible to approve or reject all procedures and specifications impacting quality, and all components, raw materials and the drug at all stages of manufacture, including intermediates, drug substance and drug product (21 CFR 211.22). Robust Laboratory Quality Management Systems (QMS) are essential to achieve and maintain sustainable regulatory compliance in a QC Unit.

Out of Specification (OOS) test results have been a major concern during manufacture of drugs for many decades. To avoid OOS in order to release the product, it has been found during audits and inspections that data or testing was manipulated (including compromising data integrity), product was re-tested repeatedly until a passing result was obtained or tests results were averaged using unapproved procedure to mask failing results. As most product specifications are based on statistical principles or methods, these methods were applied in an unethical manner to test a lot repeatedly until a passing result was obtained. The product was released on one passing result. Such practice has been known as "testing into compliance" and became a major issue following the 1993 lawsuit between the US Government and Barr Laboratories. Following historic judgement by Judge Alfred M. Wolin in 1993 on US versus Barr and FDA’s OOS Guidance issued in 2006 (Draft Guidance in 1998), handling OOS results and performing investigation into OOS by pharmaceutical companies receive close scrutiny during regulatory inspections.

The CAPA system is an important QMS in the Pharmaceutical Industry, and is a critical tool to achieve sustainable compliance through continuous improvement. A robust CAPA system, supported by a thorough investigation to find a root cause helps in improving manufacturing operations, the company and the business. As per ICH Q10 Guidelines, the pharmaceutical company should have a system for implementing CAPA resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring.





Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

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

Session Start Time: 9:00 AM

  • Introduction – Roles & Responsibilities of Quality Control Unit and Overview of Laboratory Quality Management System
    • Quality Control Unit (21 CFR 211.22)
      • Reporting Structure
      • Responsibilities
    • Laboratory Quality Management Systems
      • An Overview
  • Data of Exception
    • Understanding Data of Exceptions
      • Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trend (OOT), Out of Frequency (OOF)
    • How to Manage Data of Exceptions
    • Deviations & Non Conformances
      • Biological Product Deviations (BPD)
    • Out of Trend
    • Out of Tolerances
    • Out of Frequency
  • Out of Specifications (OOS)
    • Understanding OOS
      • Regulations, History and Background
      • FDA’s Citations on OOS in QC Labs
      • Uncertainty of Methods & Re-testing
      • Barr’s Case
  • Out of Specifications (OOS), Continued
    • FDA Guidance Document on OOS
      • Phase I Investigation
      • Phase II Investigation
      • Re-testing
      • Re-Sampling
      • Outlier Test
    • Concluding the Investigation & Final Thoughts
      • Root Cause Analysis
    • OOS in Microbiological Testing
      • Challenges
      • Best Practices
      • Example – Investigation in Sterility Test Failure
    • Mitigating OOS Risk
  • Corrective and Preventive Actions (CAPA)
    • Definitions
      • Correction
      • Corrective Action
      • Preventive Action
    • Regulatory Requirements and Guidance
    • CAPA Process
      • Non Conformance/Deviation/OOS (Problem)
      • Root Cause Analysis
        • Identify Root cause (Critical for Effectiveness of CAPA)
      • Correction of Problem
      • Corrective Action
        • Implement CA
      • Preventive Action
      • Monitoring Effectiveness and Sustainability of CAPA
        • Review
        • Verify (Problem does not recur)
        • Analyze (Monitoring)
    • Making Change to Approved Applications (Change Control)




Meet Your Instructor

Rajesh Gupta
Visionary Scientific & Compliance Consultant and Former Deputy Division Director and Lab Chief, Div of Product Quality, FDA CBER

Rajesh K. Gupta has a Ph.D. in microbiology and is the Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years' experience in the development, production, testing and regulation of biologics, working at both the regulatory agencies and the industry.

At FDA, CBER, he was a Deputy Director and the Lab Chief in the Division of Biological Standards and Quality Control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods.

In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH), in the USA and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in sterility assurance for biological products, adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and has made numerous presentations at scientific and regulatory meetings.





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