Institute for International Research

Description

This course details the technical, regulatory and quality practices necessary for setting specifications for a wide variety of biological and biotechnological products. The roles of specifications and control limits in a total quality system are emphasized. Justification for the selection and validation of stability-indicating analytical methods and the establishment of suitable shelf-life specifications is discussed. The scope and objectives of specifications used to release and monitor pre-clinical lots, clinical lots and commercial lots are compared. The types of stability and validation data that should be generated to support specifications are presented and you will learn the regulatory requirements for setting specifications, and the rationale behind them.

Agenda

• Basic Principles of Specifications and Stability
  • goals of stability studies throughout the product lifecycle
  • current practices in regarding stability against specifications
  • principles of kinetics
  • accelerated and stress stability studies
• Basic Statistical Principles
  • the role of statistics in stability and specifications
  • interpreting statistical results
  • scale of analysis and other statistical "potholes"
  • using statistical design to improve information and reduce risk
• Modeling Stability Data using Regression Analysis
  • modeling linear kinetics using simple linear regression
  • goodness of fit and detecting nonlinearity
  • fitting nonlinear kinetics
  • shelf life determination per ICH Q1E: Evaluation of Stability Data
• Regulatory Guidances
  • chemical guidances: ICH guidance's on drug product and drug substance, matrixing and bracketing, and stability analysis
  • biotechnology guidances: ICH guidance on Quality of Biotechnology Products
  • vaccine guidance's: WHO Guideline on Stability Evaluation of Vaccines
• A Rational Approach for Setting Specifications for Biological and Biotechnology-Derived Products
  • fundamental principles of specifications
  • specifications and Quality by Design
  • clinical support of specifications
  • release and manufacturing models
• Maintaining Specifications Post Licensure
  • ongoing stability studies: goals and issues
  • comparing stability after a process or facilities change
  • evaluation of product quality after a temperature excursion

Who Should Attend?

This course is designed for scientific, regulatory, and quality personnel involved in setting and supporting specifications and control strategies for biotechnology-derived drug products, including Managers, Supervisors and Scientists from R&D, Production, Quality Control, Statistics, Quality Assurance and Regulatory Affairs groups

Instructor

Timothy Schofield, Director, U.S. Regulatory Affairs, GlaxoSmithKline
Timothy Schofield is a Director in the U.S. Regulatory Affairs department of GlaxoSmithKline, where he provides regulatory support to vaccines. Prior to joining GSK Tim worked at the Merck Research Laboratories heading the Nonclinical Statistics unit, supporting development and manufacture of Merck pharmaceuticals, biologics, and vaccines. In addition to his service to GSK, Tim has held several positions on industry and regulatory committees. He received a Bachelor of Science degree in mathematics in 1973 from Lafayette College, Easton, PA, and a Master of Science degree in statistics in 1976 from the University of Pennsylvania in Philadelphia.