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).

This 90 minute seminar educates participants on the importance guidelines associated with the development and submission of an FCC monograph submission. Topics reviewed include the value of the FCC monograph and its role in the standards-creating process, the contents of an FCC monograph and/or revision and information on the submission process for new or revised FCC monographs. Upon registration the student will receive a link to download the recording. USP is pleased to provide this important material at the low price of $99. For questions, please write to pharmed@usp.org.

This 90 minute seminar educates participants on the importance of the FCC Forum and how to impact the standards in the FCC. Upon registration the student will receive an email link to download the recording. USP is pleased to provide this important material at the low price of $99. For questions, please write to pharmed@usp.org.

This 90 minute seminar showcases the history and reach of the FCC and the components that comprise the compendium. Upon registration the student will receive a link to download the recording. USP is pleased to provide this important material at the low price of $99. For questions, please write to pharmed@usp.org.

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.

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, media fill testing related to these various levels, and various sterilization methods that can be used when preparing hazardous drugs. The course will also discuss the application of USP Chapters <71> Sterility Tests and <85> Bacterial Endotoxin Test as they relate to Chapter <797>. Aseptic isolators, a room diagram of high-risk versus low risk compounding, and pictures of a hazardous compounding clean room are also covered. Approximately 90 minutes. Lecture conducted by Don Filibeck, Pharm.D., National Director, Pharmacy Services, Critical Care Systems and Larry Griffin, RPh. retired Director of Pharmacy Palestine Medical Center, Texas.

This 90 minute seminar provides instruction on key uses of the FCC from a compendial and practical perspective. Upon registration the student will receive an email link to download the recording. USP is pleased to provide this important material at the low price of $99. For questions, please write to pharmed@usp.org.

This course will discuss radiopharmaceuticals as compounded sterile preparations and identify the specialty risk categories related to these products. The course will also review allergen extracts, describe different sterilization methods, and how to perform bubble point testing. Approximately 90 minutes. Lecture conducted by Samuel Augustine, Pharm.D., FAPhA, Associate Professor, Creighton University School of Pharmacy and Health Professions and David Newton, Ph.D., Professor, Shenandoah University, Virginia.

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/.