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OOS And Setting Specifications For Pharma, Biopharma And Combination Products

This course strengthens the ability to establish scientifically appropriate specifications that support product quality, regulatory readiness, and lifecycle consistency across pharmaceutical and biotechnology-derived products. Participants will improve specification-setting decisions that reduce avoidable OOS events and support reliable market release standards. This Course is designed for professionals responsible for product quality, specification setting, lifecycle management, and compliance oversight.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Kelly Thomas
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3416
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Out-of-specification results in pharmaceutical, biotechnology-derived, and combination products can originate from multiple sources, including laboratory errors, process variability, material characteristics, production challenges, and supply chain conditions. While some contributing factors may be unavoidable, inappropriate specification settings remain a preventable source of recurring quality issues. Establishing meaningful and scientifically justified specifications is therefore essential for maintaining product consistency, safety, efficacy, and regulatory acceptance throughout a product’s shelf life.

This course addresses specification development across drug substances, APIs, starting materials, excipients, and finished products using a lifecycle-based approach informed by preclinical and clinical data. Particular attention is given to patient-centric impurity specifications and the distinction between release and shelf-life specifications. The content also clarifies critical terminology associated with OOS, OOT, OOE, quality attributes, and control limits, helping organizations strengthen quality oversight and inspection preparedness.

  • Specification Decisions That Support Product Lifecycle Control :

    Participants will strengthen their ability to establish and maintain scientifically appropriate specifications across development and commercial stages. The course clarifies how preclinical, clinical, and process capability data influence specification ranges, helping teams reduce unnecessary quality deviations while maintaining product consistency, shelf-life suitability, and regulatory expectations for pharmaceutical and biotechnology-derived products.

  • Improved Readiness for Quality and Regulatory Review :

    The course provides practical context for interpreting OOS, OOT, and OOE events in relation to specification settings and quality attributes. Participants will gain clearer judgment when defining release versus shelf-life specifications, supporting more consistent quality oversight, stronger documentation practices, and improved preparation for regulatory inspections and product quality evaluations.

Key Areas Covered

  • Terminology associated with CQA, CPP, OOS, OOT, OOE, quality attributes, control limits, and specifications
  • Differences between release specifications and shelf-life specifications for pharmaceutical and biotechnology-derived products
  • Specification setting approaches based on early-stage development and preclinical data
  • Using preclinical and clinical data to establish scientifically appropriate specification ranges
  • Lifecycle-based approaches for establishing global specifications across product development stages
  • Patient-centric specification considerations for drug substance and drug product impurities
  • Specification setting considerations for APIs, starting materials, raw materials, excipients, and finished products
  • Validation and compliance experience relevant to 21 CFR Part 11 and quality system oversight

Who Must Attend

  • QA/QC Departments & Teams
  • Research & Development Groups
  • Regulatory Affairs Professionals
  • Manufacturing & Production Units
  • Engineering & Operations Teams
  • Product Development Teams(Formulation & Analytical)
  • Marketing & Documentation Teams
  • Supply Chain Departments

Quality training, expert insights, and answers that matter. Know your Expert

KELLY THOMAS

Ms. Thomas has more than twenty years of cGMP industry experience across pharmaceutical and medical device manufacturing operations, with direct involvement in quality systems, validation activities, and compliance management. Her background includes process and product validation, facilities validation, CSV, 21 CFR Part 11, equipment qualification, cleaning validation, and test method validation. Her experience applying risk-based approaches and Lean principles to regulated manufacturing environments directly supports the specification-setting and OOS management considerations addressed in this course.

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“Content was put together well. Didn’t feel like random slides. One thing actually led to the next.”

Manager, Quality Assurance

“Examples were relatable. Not generic. We could map it to what we are currently doing.”

Supervisor, Quality Control

“Liked the way concepts were broken down. Not too heavy.”


Engineer, Engineering

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