Performing an Effective Out-of-Specification Result Investigation

Why Should You Attend:

FDA inspectional findings (form 483’s), warning letters, product recalls and plant shut down (voluntary or involuntary) relating to incomplete, ineffective and non-compliant OOS investigations impacts a manufactured product. Failure, Deviation or OOS results investigations regardless of its impact must be adequately documented, analyzed for root cause with a justifiable retest plan and planned corrective action plan. The result of an OOS investigation impacts the quality of the cGMP manufactured product and its labeled claim to avoid it from being tagged as ‘adulterated” which may potentially lead to a product recall, complaint and further actions by the FDA. Understanding how to identify a true OOS from an invalid assay, performing a retest based on the findings of the OOS investigation, when and how to use “averaging” of a test and re-test result versus an “outlier” is critical in the achievement of regulatory compliance.

This 90-minute training will benefit manufacturers of cGMP products in designing an effective, robust and compliant OOS investigation process.

Learning Objectives:

This webinar will provide the attendee the following skills:

1. Understand the requirements of an OOS investigation and how to design a compliant and effective OOS investigation system
2. Step by step guidance on how to perform a compliant, effective and in-depth investigation of Out-of-Specification (OOS) results
3. Knowledge of the requirements of 21 CFR Parts 210 and 211, FDA’s Guidance for Industry “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production” and Q7A “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients” (ICH Q7A)
4. Understand how to differentiate between a true OOS, a Known Lab Error (KLE), an Atypical Event (ATE), and an Invalid Assay
5. Understand how to perform a product retest, under what circumstances is a retest permitted per regulations and how to analyze/apply the initial data and a retest data from an OOS investigation
6. Quality Assurance ability to interpret and disposition a batch of product having a confirmed, unconfirmed or inconclusive OOS test result investigational findings
7. Understand the various types of ways to document an OOS investigation and the advantages/disadvantages of each system

Areas Covered in the Webinar:

Module 1:

1. Requirements/Regulations Guiding OOS Investigation and its Application:
1. Understanding the requirements of 21 CFR Part 211, FDA Guidance on OOS and ICHQ7A.
2. Definition, Objectives, Types and Examples Different Types of Investigations:
1. Types of Laboratory Investigation
2. Definition and Examples of a Known Laboratory Error (KLE)
3. Definition and Examples of an Atypical Event (ATE)
4. Definition and Examples of a Laboratory Calibration Out-of-Tolerances (LCOT).
5. Definition, Objectives and Examples of OOS Results Investigation.
3. Identifying a True OOS from a False OOS Result:
1. How to Identify OOS Results Requiring Investigation

Module 2:

1. Processing an OOS Investigation Results:
1. FDA Guidelines for Investigating an OOS Results
2. OOS Results Investigation from Reporting through Closure (i.e. Step-by Step performance of the investigation from Analyst through Management Review and Approval)
2. Retesting Samples during an OOS Investigation:
1. Criteria for Retesting/Predefined Retesting Plan
2. How and When to Perform Resampling during on an OOS Investigation

Module 3:

1. Reporting and Interpreting OOS Test Results:
1. Appropriate and Inappropriate use of Averaging of Test Result
2. Appropriate and Inappropriate use of Outlier Test Result
2. Quality Department’s Interpretation of OOS Investigation Result and Product Disposition:
1. Interpreting and disposition products when an OOS is confirmed, unconfirmed and inconclusive.
2. Documentation, Closure and Approval of an OOS investigation.
3. Types of OOS Investigation Systems:
1. Paper Based (Manual) Systems
2. Automated Systems

Who Will Benefit:

This webinar will provide a great resource to Pharmaceutical, Biotechnology, Biologics, Drugs, Medical Device, In-vitro Diagnostics Industry personnel within the following functions:

• Quality Control
• Quality Assurance
• Microbiologist
• Chemist
• Analysts
• Manufacturing
• Validation
• Facilities
• Materials
• Engineering
• Vendors/Suppliers

Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC

Charity Ogunsanya has more than 23 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and is currently in the Advanced Academic Master’s Biotechnology Program at the Johns Hopkins University with concentration in Biotechnology/Biodefense. She is the CEO/Owner of her consulting firm named Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.

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