Laboratory Investigations for Out of Specification Results

Why Should You Attend:

When an out of specification or out of trend result is obtained on an active pharmaceutical ingredient or a pharmaceutical product, both ICH and CFR guidances indicate a need for investigation. These documents do not give instruction, guidance, tools or expectations as to how an issue should be resolved.

At times, the root cause is easily identified and the investigation is conducted swiftly. However, when the root cause cannot be easily assessed by initial review, it can be frustrating to determine the appropriate path for the investigation. There may be multiple potential avenues of exploration.

This webinar will explore successful approaches to laboratory investigations and also explore approaches which may have potential for pitfalls. There is often a natural tendency to quickly focus on a potential cause and attempt to build a corrective or preventive action based on this. At times, there is more than one root cause or the root cause is not the obvious or first issue discovered.

Learning Objectives:

To understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.

Areas Covered in the Webinar:

• ICH guidelines for investigations
• 21 CFR 210 & 211 requirements for investigations
• Relevant investigational tools
• Initiation of an investigation
• Controlling the scope of an investigation
• Finding acceptable resolution
• CAPA
• Root causes

Who will Benefit:

This webinar will provide valuable assistance to all personnel in:

• QC functions in general
• QC testing groups
• QC investigation groups
• Development groups investigating assay failures
• QA reviewers and investigators

Barbara Berglund
COO, CMC Turnkey Solutions

Barbara Berglund has been working in the pharmaceutical industry, specifically with sterile Parenteral drugs, for over 10 years. Her experience includes her current role as a QC Manager as well as roles in the laboratory, project management, and clinical trial manufacturing. The QC group she manages is directly responsible for method transfer and validation activities in support of contract manufacturing clients. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.

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