This 4-part series of 60-minute presentations will expound on the need for stability testing and its importance to patient’s health. Each lecture will address a specific aspect of stability testing including:
- Discuss ICH Q1A through Q1E Guidelines
- Evaluate the positives and negatives value of global harmonization
- Explain how to use stability data as part of a science and risk-based approach to establishing specifications
Who Should Attend
CMC scientists and pharmaceutical professionals involved in drug substance and drug product development.
Importance of Pharmaceutical Stability Testing to Patients, Products and Regulators (Why perform stability testing and introduction to ICH Q1A-E)
Drug Substance Stability Testing, How Much is Enough (ICH Q1A(R2), Q1B, Q3A-D, Q5C)
Current Regulatory Perspectives on Drug Product Stability Testing (Standard approaches, supporting data, accelerated programs, in-use testing
Utilizing Stability Data as Part of a Science and Risk-based Approach to Establishing Specifications (Bringing Drug Substance and Drug Product together)
Terry Ocheltree, PhD, President of PharmTree Consultants, possesses over 30 years of diverse pharmacy, pharma, and biopharma experience including 14 years in regulatory affairs, of which eight (8) years was at the Food and Drug Administration (FDA) in the Office of New Drug Quality Assessments (ONDQA) as a reviewer and division director. He was involved in reviewing and taking actions on INDs, NDAs and sNDAs, and championing the use of Quality by Design (QbD), Process Analytical Technology (PAT), Real Time Release Testing (RTRT) and the concept of Product Lifecycle Management. Terry’s regulatory experience includes working with small molecules, biologics, botanicals, medical devices, medical apps, combination products and generic drugs. Prior to joining the FDA, Terry was involved in pre-formulation and formulation development, manufacturing scale-up, technical support, and manufacturing of various dosage forms (e.g., transdermal patches, immediate and controlled release tablets and capsules, oral and topical liquids) at various companies including 3M and Cardinal Health. Terry earned a BS in Pharmacy at the University of South Carolina (Columbia, SC) and a Ph.D. in Pharmaceutics at the Medical University of South Carolina (Charleston, SC).