Course Catalog

Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

Stability program plays a pivot in pharmaceutical development, thus a sustainable stability program in compliance with current regulations is critical to new pharmaceutical product registration. Stability-indicating methods are necessary to determine product quality throughout its shelf life. This course presents a comprehensive overview of FDA, ICH and WHO stability requirements for pharmaceutical products including technical and regulatory aspects to design a global stability program which are cost effective and in compliance. This course will be taught by the editor of two stability books.

Registrants will need to purchase a copy of Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices, by Huynh-Ba (Springer 2008) in addition to their registration, and which is available for purchase at a discount through ACS. Please contact
Andrea Glenn to purchase your copy. Quantities are limited.

Course Details

Key Topics

  • Overview of stability role in the drug development process
  • Examine factors that may affect expiration dating of drug products
  • Review cGMP and ICH stability requirements
  • Discuss impact of global stability requirements
  • Develop stability indicating analytical methods
  • Design forced degradation studies for HPLC analyses
  • Review warning letters and recent citations

Information

Stability program plays a pivot in pharmaceutical development, thus a sustainable stability program in compliance with current regulations is critical to new pharmaceutical product registration. Stability-indicating methods are necessary to determine product quality throughout its shelf life. This course presents a comprehensive overview of FDA, ICH and WHO stability requirements for pharmaceutical products including technical and regulatory aspects to design a global stability program which are cost effective and in compliance. This course will be taught by the editor of two stability books.

Registrants will need to purchase a copy of Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices, by Huynh-Ba (Springer 2008) in addition to their registration, and which is available for purchase at a discount through ACS. Please contact
Andrea Glenn to purchase your copy. Quantities are limited.

Who Should Attend

This one-day course will benefit QC/QA analysts, development managers, regulators, and R&D researchers, investigators, auditors, inspectors, who perform stability testing, develop methods, set up stability program, evaluate stability data of pharmaceutical products.<br
To get the most out of the course, we highly recommended that you have at least two years of pharmaceutical analysis or drug development experience.

To get the most out of the course, we highly recommended that you have at least two years of pharmaceutical analysis or drug development experience.

Benefits

  • ¬†Understand stability role in the drug development process
  • Design stability study based on ICH and global requirements
  • Recognize the importance of stability indicating methods
  • Develop stability program based on drug development phase
  • Comprehend the regulatory expectations through warning letters

Agenda

FDA/ICH Guidances regulating Product Stability Program

  • Overview of stability role in the drug development process
  • Review cGMP for stability testing requirements
  • Discuss stability requirements from ICH and FDA

Technical Aspects of Drug Stability

  • Develop stability indicating analytical methods
  • Design forced degradation studies for HPLC analyses
  • Identify special studies to support stability methods
  • Concepts of bracketing and matrixing

Regulatory Aspects of Stability Program

  • Review warning letters and citations
  • Prepare stability protocols according to regulations
  • Discuss stability reporting formats for regulatory and CMC
  • Discuss Stability related operation procedures

Interactive Exercises and Discussion

Course Locations

Date

TBA

Check-in opens at 7:30 a.m. on the day of the course.

Course runs from 8:30 a.m. to 5:00 p.m.

Register Via Mail

Venue

The course fee includes a course binder and a continental breakfast each day.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax or mail and mention this discount. May not be combined with any other offer.


Pricing
  Member Non-Member
Advanced $895 $1,095
Standard $1,095 $1,295

About the Instructor

  • Kim Huynh-Ba

    has almost 28 years of experience in GMPs, analytical development and stability sciences in Pharmaceutical Industry.