Pharmacopeial Education Courses

This ON-DEMAND recorded webinar is from a live webinar that occurred on January 19, 2010. Once you register for this ON-DEMAND offering, you will be granted immediate access with access instructions provided in your confirmation email. You will have access for 30-days from date of purchase. You may view the recording as often as you like during the 30-day access period.

The General Notices section of the United States Pharmacopeia-National Formulary (USP-NF) holds vital information for the use and understanding of the monographs, general chapter testing procedures, and other related topics described in the USP-NF and other compendial publications. Reading and using the General Notices section of the USP-NF as a reference resource will aid the user in understanding how to interpret findings, give information on the use of statistics and aid in the clarification of terms and definitions as used with the compendia. The cornerstone of your understanding begins with a review of this important USP topic. Approximately one hour. USP is pleased to present this important material free of charge. This program requires Flash V8. Flash V8 player is available free of charge from Adobe Inc. Go to: http://www.adobe.com/go/getflash/.

This course will explain the redesign process and provide specific examples of changes that users of the USP-NF will encounter and may not understand without proper guidance. This course will also highlight the importance of public comment and present instructions on how to provide feedback on the redesign. Approximately one hour. USP is pleased to provide this recording free of charge. This program requires Flash V8. Flash V8 player is available free of charge from Adobe Inc. Go to: http://www.adobe.com/go/getflash/.

This ON-DEMAND recorded webinar is from a live webinar that occurred on June 1, 2010. Once you register for this ON-DEMAND offering, you will be granted immediate access with access instructions provided in your confirmation email. You will have access for 30-days from date of purchase. You may view the recording as often as you like during the 30-day access period.

This course provides an introduction to the basic concepts and calculations of the high performance liquid chromatography analytical procedure as applied in the pharmaceutical industry. The course provides the student with the fundamental scientific underpinnings of the technique in preparation for application of HPLC in everyday practice for pharmaceutical quality control and assurance. The content of Module 1 includes the basic objectives of HPLC, theory and calculations including k prime and relative retention and system suitability requirements. Plan to spend approximately 60-90 minutes on this material.

This course provides an introduction to the basic concepts and calculations of the high performance liquid chromatography analytical procedure as applied in the pharmaceutical industry. This module covers equipment components, practical considerations, trouble-shooting and issues related to USP and HPLC such as definitions, types of tests and calculation of results for monographs. Plan to spend approximately 60-90 minutes on this material.

USP’s General Chapter <797> Pharmaceutical Compounding─Sterile Preparations was significantly revised and became official in June 2008. Many professional organizations and state boards of pharmacy have directly or indirectly implemented the requirements set forth in this Chapter. Therefore, it is incumbent upon healthcare practitioners, and others who are involved in the practice of pharmaceutical compounding, to understand <797> requirements so it can be appropriately interpreted and implemented. This recording will provide a comprehensive review and understanding of the Chapter and give attendees the tools to help with implementing the standard. Approximately 90 minutes. Lectures provided by Mary Baker, Pharm .D. Senior Medical Manager, Hospira and Eric Kastango, MBA, President/CEO (Clinical IQ).

Proper cleansing and garbing is critical for ensuring the sterility of compounded products. This course will cover the specific sections of <797> related to personal cleansing, standard operating procedures, and verification of compounding accuracy and sterility. Approximately 90 minutes. Lecture conducted by Keith. St. John, M.S., Director, Infection Prevention/Control & Occupational Health, The Children’s Hospital of Philadelphia and Don Filibeck, Pharm. D, National Director, Pharmacy Services, Critical Care Systems.

Planning and designing a clean room for sterile compounding activities is challenging and requires architectural expertise and input. This course outlines the key issues involved with facility design and the placement of primary engineering controls. At the conclusion of the course, attendees should have a better understanding of environmental monitoring and sampling for viable and non-viable particles, and the types of assessments required. Attendees should also be able to understand the different facility design approaches in chapter <797>. Approximately 90 minutes. Lecture conducted by Jim Wagner, President, Controlled Environmental Consulting and Eric Kastango, MBA, President/CEO (Clinical IQ).

Microbial contamination (i.e., contamination caused by microbial organisms including spores and endotoxins) as well as physical and/or chemical contaminations are serious concerns for compounded products that are supposed to be sterile. This course will cover the various contamination risk levels (low, medium, and high risk levels and 12 hour beyond use dating) as well as various sterilization methods that can be used when preparing hazardous drugs, radiopharmaceuticals, and allergen extracts. Approximately 90 minutes. Lecture conducted by Samuel Augustine, Pharm.D., FAPhA, Associate Professor, Creighton University School of Pharmacy and Health Professions and Larry Griffin, RPh. retired Director of Pharmacy Palestine Medical Center, Texas.