Course Information
Course Title: Impurities in Pharmaceuticals - A Survey Course
Categories: 1 - Liquid Chromatography
2 - Chiral Separations
3 - Pharmaceutical Sciences
4 - Quality/Regulatory/Compliance
5 - Gas Chromatography
Instructor(s): Bernard Olsen Course Number: 7
Affiliation: Olsen Pharmaceutical Consulting
Course Date: 03/14/2012 - Wednesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $455 ($655 after 2/13/12) Textbook Fee:

Course Description
This course will provide information on a wide variety of impurities that may be present in small molecule drug substances and drug products. Each impurity topic will include a discussion of regulatory expectations, analytical considerations and method development, specifications, and strategies for addressing impurities throughout drug development. Specific topics to be covered include related substance process impurities, other synthetic process impurities, degradation products, excipient impurities and interaction products, stereochemical impurities, residual solvents, potentially genotoxic impurities, inorganic impurities, extractable and leachable impurities, and solid state forms.

Target Audience
This one-day course will benefit analytical chemists, synthetic process chemists, engineers, formulation scientists, regulatory and quality personnel, and others in the pharmaceutical industry who would like to obtain a better background regarding issues involved with drug impurities and how to address them.

Course Outline
1) Process related impurities in drug substances
   - ICH guidelines, impurity qualification, impurity reporting
   - Impurity origins, control, specifications
2) Degradation impurities in drug substances and drug products
   - ICH guidelines, specifications
   - Forced degradation studies
   - Excipient interactions
3) Analytical methods for impurity investigation and control
   - Screening methods
   - Quality control methods
4) Chiral purity
   - Specifications and chiral separation methods
5) Residual Solvents
   - Specifications and GC methods
6) Genotoxic Impurities
   - Regulatory guidances
   - Assessment of impurities for genotoxicity
   - Analytical considerations for trace impurity determination
7) Inorganic impurities
   - Specifications, compendial and plasma spectrochemical methods
8) Extractables and leachables
   - Investigations 
9) Solid State forms
   - Polymorphism, specifications, analytical methods

Course Instructor's Biography
Dr. Bernard A. Olsen has over 29 years of experience at Eli Lilly and Company related to chemistry, manufacturing and control aspects of drug substances and drug products. He has contributed to the development and support of over 25 commercial drugs and numerous developmental drugs. He currently provides consulting services to the pharmaceutical industry and serves as Chair of the USP Expert Committee on Monograph Development-Small Molecules 3. He has published and given invited lectures on a wide array of drug development and analytical topics including high performance liquid chromatography, chiral separations, impurity determination and control, genotoxic impurities, physical property characterization, drug counterfeiting, regulatory aspects of drug development, and quality control. His undergraduate degree is from Nebraska Wesleyan University and his doctorate in analytical chemistry is from the University of Wisconsin-Madison. He is a Fellow of the American Association of Pharmaceutical Scientists.