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The Microbiology of Water in a GMP Environment

Oct 25, 2019
Rockville, MD

  • Education
  • The Americas
Closed

Overview

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility revolves around the health of each water system within that facility. How often have we learned of a facility being closed for weeks at a time because of a water system that has exceeded its microbiological specifications?

This interactive training course will examine a variety of the issues surrounding water in a facility to include the testing of each water source and to what extent. It will also cover testing requirements during commissioning and testing on an on-going basis. Participants will examine Quality Risk Management (ICH Q9) and discuss how a properly developed Facility Water Validation Plan may lead to a logical, reduced requirement for testing vs. time. Participants will also explore the time requirement for testing before reduced testing might occur and why some organizations refuse to accept this path.

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Agenda

  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

Trainers

Barry Friedman
Barry Friedman
Barry A. Friedman, PhD, LLC
Bio
Barry Friedman
Barry A. Friedman, PhD, LLC

Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness participation, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. He is a frequent seminar and webinar speaker and maintains an active Blog (200+ blogs) on the subject of "Regulatory Compliance." 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. In addition to the professional history listed above, other associations have included Chesapeake Biological Laboratories, 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 The Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from The Ohio State University in Microbiology.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Facilitate the development of a water sampling system
    2. Recognize the rationale for required tests and their frequency by examining the various requirements to obtain current and future assay frequencies
    3. List and apply the differences among USP, EP and JP compendial water requirements
    4. Explain the commonalities and differences within purified water and WFI systems
    5. Appraise and solve various water system problems
  • Who Should Attend

    This training course is intended for professionals who are responsible for pharmaceutical water systems used in drug manufacturing.

    Departments
    Facilities, Manufacturing, Quality Control, Quality Assurance, Validation

    Roles
    Supervisor, Manager, Engineer, Specialist, Analyst

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Rd
Rockville, MD

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  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Bethesda North Marriott Hotel & Conference Center. The rate is $249 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 16, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Bethesda North Marriott Hotel & Conference Center at +1 (301) 822-9200. Please make sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6:00 p.m. (EDT) on the date of arrival otherwise specified on your reservation information.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

Bethesda North Marriott is located at 5701 Marinelli Road, Rockville, MD 20852.

$15 Self Parking

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price By September 10, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839


Regular Registration
Registration Type Price After September 10, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839


* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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