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Forced Degradation and Impurity Monitoring

October 22, 2019 @ 12:00 AM - 11:59 PM

San Diego, 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 Roadmap and save $200.00!  Use promo code 2DAYSAVE to register for both seminars and save!***


  • l.
    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
  • ll.
    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>
  • lll.
    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
  • llll.
    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, Executive Director, Pharmalytik

    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.
  • Sheba Zaman B.S. in Computer Science Head of Product Specialists and Training Services Novatek International

    Sheba Zaman has been serving in a technical role at Novatek International for over 17 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade to establish procedures, work instructions, validation scripts and training program related to their data management systems.


  • H&A Scientific, Inc. is a scientific software development firm specializing in pharmaceutical industry support. We develop, validate, and market quality computing systems for scientific data acquisition, processing, and data management. We have been creating programs for the laboratory since 1992. Our products have been designed under our Quality System to adhere to the current GAMP guidelines. We develop Quality Software products based on the needs of pharmaceutical companies subject to the constraints and compliance of the Food and Drug Administration (FDA). Our flagship product, SLIM, is a commercial off-the-shelf solution for total management of a company's drug stability program.
    Website: http://www.hascientific.com/en/


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    Bio-IT World provides outstanding coverage of cutting-edge trends and technologies that impact the management and analysis of life sciences data, including next-generation sequencing, drug discovery, predictive and systems biology, informatics tools and personalized medicine.
    Website: http://www.bio-itworld.com/
  • Pharmaceutical Outsourcing

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



October 22, 2019
12:00 AM - 11:59 PM
Event Category:


Catamaran Resort Hotel and Spa
3999 Mission Boulevard
San Diego, CA 92109 United States
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