Advanced Stability Testing

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Forced Degradation and Impurity Monitoring

October 23, 2018

Philadelphia, United States

Stability is a critical quality attribute in the development of pharmaceutical product. Stability data establishes quality of the product and support the proposed specifications. Pharmaceutical quality system (PQS) must be built to maintain integrity and quality throughout the product lifecycle. Stress testing and stability-indicating methods are also necessary in the product development and monitoring of stability studies. Different regulations and initiatives of monitoring organic impurities; and evaluation of stability data and data trending based on Quality-by-Design (QbD) and Quality Risk Management (QRM) to establish critical quality attributes are addressed. This live and interactive course delivers advanced technical issues to design the most effective stability program; and covers forced degradation studies to establish stability-indicating methods, monitoring organic impurities, handling deviations, data investigations, and different control strategies to improve stability program and manage regulatory inspections. It is designed for directors, managers, supervisors, project managers, analysts, quality assurance professionals or quality control personnel working with pharmaceutical products.

Participants must take the roadmap course or have at least 3-year experience with the stability program to participate in this course.


***Attend this event along with Stability Testing & Program Management Roadmap and save $200.00!  Use promo code 2DAYSAVE to register for both seminars and save!***


  • I.
    Validation of Stability-Indicating Methods
  • • The role of forced degradation studies
  • • Validation of analytical methods and USP <1225>
  • • Analytical procedures based on FDA validation guidances
  • • Transfer strategies, USP <1224> to implement procedures
  • II.
    Established Control Strategies for Organic Impurities
  • • Impurities and Q3 A&B expectations
  • • Impurities vs. degradation products
  • • Monitoring and reporting impurity results
  • • Relationship of USP proposed general chapters <476> & <1086>
  • III.
    Investigation of Out-of-Specification (OOS) & Out-of-Trend (OOT) Program
  • • Establish product specifications
  • • Understand significant changes
  • • Reporting and handling of OOS and OOT results
  • • Investigation process and documentation
  • IV.
    Optimizing Stability Programs for Continuous Improvement
  • • Establish control strategies for stability programs
  • • Managing changes to stability programs
  • • Lean stability and risk management
  • • Conduct audits and manage inspections


  • Kim Huynh-Ba, Editor of the Handbook of Stability Testing of Pharmaceutical Products: Regulations, Methodologies, and Best Practices

    Kim Huynh-Ba has over 25 years of experience in quality systems, project management, strategic drug development and stability sciences. She currently is the Executive Director and CEO of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies. Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT). She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. Kim has authored numerous technical publications, book chapters and has spoken extensively, both domestic and internationally, in the compliance and quality areas. She is the editor of 2 well-known Stability books: the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010). She is also working on a manuscript for the textbook “Analytical Chemistry: An Introduction to Pharmaceutical GMP Laboratory,” that is expected to be available in 2019. Kim can be reached at kim.huynhba@pharmalytik.com.



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    Website: http://www.bio-itworld.com/
  • Pharmaceutical Outsourcing

    Addressing up-to-the-minute manufacturing challenges
    Website: http://www.pharmoutsourcing.com/



October 23, 2018
Event Category:


Cambria Hotel
219 S Broad St
Philadelphia, PA 19107 United States
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(215) 732-5500

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