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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

ComplianceOnline

Tuesday, January 31, 2017 at 8:30 AM - Wednesday, February 1, 2017 at 4:30 PM (EST)

Essentials Of USP Microbiology - Reading Between the...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (Early bird price)
For Registrations after January 15, 2017 - $1899
Jan 31, 2017 $1,299.00 $0.00
Seminar One Registration Jan 31, 2017 $1,999.00 $0.00
Seminar One Registration (With 2 Nights Stay) Jan 31, 2017 $1,899.00 $0.00

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

Event Details

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

 

Who Will Benefit:

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

 

Meet Your Instructor

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

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.


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

 

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

Have questions about Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters: 2-Day In-Person Seminar? Contact ComplianceOnline

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When & Where


Orlando

Orlando, FL

Tuesday, January 31, 2017 at 8:30 AM - Wednesday, February 1, 2017 at 4:30 PM (EST)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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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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