Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters: 2-Day In-Person Seminar training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters: 2-Day In-Person Seminar  

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Seminar Summary:

The objective of this two day Essentials of USP Microbiology seminar is to explore USP General and General Information Chapters  (see full course description)

 

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Training Course Syllabus:


Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters: 2-Day In-Person Seminar

By: Barry A. Friedman, Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Course Description:
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

Course Outline:
Day 1 (8:30 AM – 4:30 PM)


Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

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
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 and how to interpret them
Team exercises to include commonalities between the various USP documents


Day 2 (8:30 AM – 4:30 PM)


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
Team exercises
Case Studies and recent Warning Letters

Seminar Summary:

The objective of this two day Essentials of USP Microbiology seminar is to explore USP General and General Information Chapters  (see full course description)

print this agenda print agenda for the Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters: 2-Day In-Person Seminar training seminar

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