ComplianceOnline

Laboratory Investigations for Out of Specification Results

Instructor: Barbara Berglund
Product ID: 702263
  • Duration: 90 Min

recorded version

$349.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This 90-minute webinar on laboratory investigations will explore successful approaches to laboratory investigations of out of trend results and also explore approaches which may have potential for pitfalls.

Course "Laboratory Investigations for Out of Specification Results" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

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 Seminar:

  • 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

Instructor Profile:

Barb Berglund, has been working in the pharmaceutical industry, specifically with sterile parenteral dugs, 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. She has hosted multiple webinars through ComplianceOnline as well as podium presentations at the PDA, IPA Canada, PMI Congress, and Pharmaceutical Community of Practice.

Topic Background:

The International Council on Harmonization (ICH) Q7A Guidance for Industry is specific to GMP practices for active pharmaceutical ingredients. There are numerous references to the requirements for investigations in the event of excursions and deviations. The approach to conducting investigations is not described; the directive is to have a complete investigation.

It seems that anytime there is an investigation, there is a dramatic push to close the investigation as quickly as possible, often without completing a thorough investigation. In addition, 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.

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