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Event :Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

Dates :Thursday August 06th, 2020 - Friday August 07th, 2020

Location :virtual seminar, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

The objective of this on-line, interactive two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn their current and updated status and to confirm that those Chapters being utilized are used correctly. USP documents that will be reviewed include:

  • USP<51> Antimicrobial Effectiveness Testing
  • USP<60> Microbiological Examination of Nonsterile Products Tests for Burkholderia cepacia Complex
  • USP<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
  • USP<71> Sterility Tests
  • USP<85> Bacterial Endotoxins Test
  • USP<1072> Disinfectants and Antiseptics
  • USP<1111> Microbiological Examination of Nonsterile Products
  • USP<1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products
  • USP<1113> Microbial Characterization, Identification, and Strain Typing
  • USP<1116> Microbiological Control and Monitoring of Aseptic Processing Environments
  • USP<1227> Validation of Microbial Recovery from Pharmacopeial Articles


 

Objectives

  • Understanding the various General and General Information USP Chapters that apply to microbiology
  • Study the focus of the chapters to include those that primarily involve non-sterile and sterile applications and their interpretation
  • Gain an enhanced knowledge of the chapters that involve the microbial environment
  • Examining the changes within the various Chapters that have recently occurred and how to interpret them
  • Review areas that are often overlooked or often misunderstood
  • Study issues that continue to exist between the USP, EP and JP (harmonization)
  • 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

Program

Day 01(10:00 AM - 4:00 PM EDT)
  • 10.00 AM: Session Start
    • Overview of the General and General Information USP Chapters that apply to microbiology
    • Focus upon those Chapters that primarily involves both non-sterile and sterile applications
    • Explore commonalities and differences between the various Chapter and how they interrelate
    • Learn how Chapters that involve the environment impact all other USP Chapters
    • Defining the differences between a “Controlled” and “Classified” environment and how they impact the USP Chapters
    • Review recently changed USP Chapters to include harmonization and how to interpret them
Day 02(10:00 AM - 4:00 PM EDT)
    • Continuing review the balance of the USP Chapters
    • Review of areas of USP microbiology that are often overlooked
    • Study issues that continue to exist between the USP, EP, and JP
    • Examination of the new regulatory attitude that is occurring with non-sterile products
    • What now constitutes a “specified” microorganism
    • Case Studies and recent Warning Letters


 

Speakers

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.


 

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virtual seminar
United States
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Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters Pharmacy
usp microbiology, usp microbiology chapters, usp general, usp general chapter changes, usp chapters, usp document, hvac, usp
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