Webinar ID:   ICT101

Handling OOS Test Results and Robust Investigations

  90 Minutes

Categories:   FDA Compliance,

Whenever regulatory authorities anywhere in the world perform an audit of a drug manufacturer, one of their most frequent findings remains the inadequate performance of the investigation of failures arises from OOS. Authorities expect stakeholders will carefully investigate failures to identify non-compliance, intervene and then evaluate the effectiveness of that intervention. Without adequate investigation and root cause analysis (RCA), those stakeholders cannot effectively identify and design successful interventions. In fact, organizations waste millions of dollars every year on ineffective interventions.

Many manufacturers run afoul of the FDA/EUGMP/ WHO over their corrective and preventive actions (CAPA) procedures, since CAPA can impact almost every area of your manufacturing operations, it’s crucial for all employees to understand at least the basics – the what, why and how. But boiling the complexities of Failures and in effective CAPA down the organizations into a severe regulatory non compliance level and resolve the issue can be a real challenge.

Why You Should Attend:

Current Regulators expectations is that “A firm’s primary goals in investigating a Failure incident should include both discovering its cause and ensuring it does not reoccur”.

This is the advanced and skill based training in specific subjects related to Out of specification (OOS) and related failures investigation and root cause analysis (RCA) –effective investigations to identify the actual, factual root cause and how to develop effective CAPA strategy to eliminate forever in good manufacturing processes and quality Control (QC) systems. This course details with current regulatory expectations on failures investigation and root cause analysis (RCA) with implementation of effective CAPA

Areas Covered in the Session :

  • Introduction
  • Determining Potential Product Impact through OOS investigation
  • The Investigation – Trigger (OOS-How from day to day today analysis)
  • Root Cause Analysis –Flow with Investigation Tools
  • RCA Tools with Case studies
  • Documentation of OOS with Phase-wise check list, (Failure Investigation Report)
  • Handling of OOS-Investigations. A detailed SOP with OOS form
  • Corrective and Preventive Action
  • Tracking and Trending
  • Recent OOS Regulatory agencies cited examples by USFDA/MHRA
  • Key Elements of the Investigation Report (RCA Report)
  • Questions and answer section

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • All API and Formulation Companies


G Sundar

G. Sundar is a quality practitioner with vast experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA, Japan guidelines.

He has conducted more than 50 GMP/GLP audits including Q10 & Q11 implementation, 50 Formulation Contract Manufacturing Units (all types of formulations,), 10 Contract Research and Analytical laboratories, 4 Clinical research CROs. He has also conducted 100 plus trainings all over India, Asia and Europe.

Mr. Sundar Ganesan is currently working as Director-Consultant at PharmQA Compliance services an independent consultant.