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Mar 2017
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Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

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Overview

The objective of this two day 'Essentials of USP Microbiology' seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those that you are using are being used correctly. USP documents that will be reviewed include USP <51>, <61>, <62>, <71>, <1072>, <1111>, <1112>, <1113>, <1116> and others. Various team exercises will be conducted to allow the participants to use these USP documents to solve 'real life' problems. Plan to bring a cross-functional group of your personnel to attend this invaluable two day seminar.

Learning Objectives:

  • The various General and General Information USP Chapters that apply to microbiology
  • The focus of the chapters to include those that primarily involve non-sterile and sterile applications
  • Chapters that involve the environment
  • Examining the changes within the various Chapters that have recently occurred and how to interpret them
  • Review areas that are often overlooked
  • Study issues that continue to exist between the USP, EP and JP
  • Examine the new regulatory attitude that is occurring with non-sterile products
  • What now constitutes a 'specified' and “objectionable” microorganism
  • Explore Form FDA 483s and Warning Letters for microbiological applications

Who Will Benefit:

  • Manufacturing
  • Product Development
  • Project Management
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Regulatory Compliance

Topic Background:

Microbiology plays a role throughout the manufacture of pharmaceutical products. Whether the final product is non-sterile or sterile, the bioburden exists from the raw materials, throughout the process and/or within the product's environment (water and HVAC) to the final product. A critical review of the overall microbiological process will determine whether the critical 'in-process' points permit the final product to meet its acceptance criteria. In addition, any 'objectionable' or 'specified' microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/usp-microbiology-chapters-general-and-information-microbiology-raw-material-api-hvac-ep-jp-seminar-training-80241SEM-prdsm?channel=eventsinamerica

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