Max Lazar	Auditing API Manufacturers and Suppliers This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions.
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Pauline McGregor	Verification of Pharmacopeia Methods Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods.
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Pauline McGregor	Quality by Design (QbD) and Analytical Methods As the industry is moving towards applying Quality by Design (QbD) to process development, the question must be asked: Is this also the way forward to revolutionise, improve and standardise our approach to method development and qualification?
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John Bauer	Physical Properties Analytical and Screening Techniques The chemical composition of the active ingredient of a pharmaceutical dosage form determines the efficacy and stability of the formulation however during manufacturing it is the physical properties of the formulation components that are critical in the unit operations.
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Dr. Norman F. Estrin	The Cosmetic-Cosmeceutical Distinction: Walking the Line in Developing Label Claims Drafting claims where you "walk the line" between cosmetic and drug claims is an art with little existing practical guidance.
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Kerry Paul Potter	Preparing for and Surviving an FDA Inspection The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.
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Barbara A. McLaughlin	Auditing Computer System Validation Materials This presentation will provide auditors who are not knowledgeable about computer system validation with a basic understanding of the requirements and expectations for validation documentation.
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John Geigert	Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical.
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Gerry O'Dell	Troubleshooting ethylene oxide (EO) processes Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification.
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Carlos M. Aquino	Law Enforcement and Pain Management Class participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II though V controlled substances that are dispensed, or prescribed by a physician as part of a pain treatment plan.
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