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October 21, 2019

San Diego, United States

Stability studies are an essential component of pharmaceutical development and manufacturing used to establish a retest date for active pharmaceutical ingredient (API) or a shelf-life for drug products (DP). The stability program studies the behaviors of API and DP under the influence of a variety of environmental factors such as temperature, humidity, and light. ICH has placed a foundation for stability program and continues to be the driving force of new quality initiatives. A comprehensive review of ICH Q1 family (Q1A to Q1F) will be done to build the program infrastructure. The product shelf-life is established based on stability data during development phases and continue to support the change control program in commercial phase. This live and interactive course delivers a comprehensive look at ICH and global regulations and operational issues surrounding the stability program. It is designed for directors, managers, project managers, quality assurance professionals or quality control personnel seeking to understand and develop an effective stability program for their pharmaceutical products.


***Attend this event along with Advanced Stability Testing and save $200.00!  Select the dual event ticket type for $1790.00 to register for both seminars and save!***


  • l.
    Drug Development Process & Global Stability Requirements
  • • Drug development process for API and DP
  • • ICH Q1A (R2) for stability program
  • • Climatic zones and global stability requirements
  • • Establish phase-specific and global stability protocols
  • ll.
    Generic Development & the Use of Compendial Monographs
  • • The development process for generic products
  • • USP structure and the use of compendial procedures
  • • Verification process, USP <1226> and documentation
  • • Keeping up with compliance with change control program
  • lll.
    Setting Up Stability Studies & Managing Stability Chambers
  • • Setting up process for stability studies
  • • Reduce testing through matrixing and bracketing
  • • Requirements of photostability studies
  • • Qualification of stability chambers
  • llll.
    Evaluation of Stability Data & Trending Stability Profiles
  • • Stability records and reports
  • • Data evaluation based on Q1E
  • • Establishment of expiration dates
  • • Stability report and CMC submission


  • 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.


  • 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 21, 2019
Event Category:


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