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Regulatory Aspects of Microbiology in a Non-Sterile Environment

Oct 22, 2020
Washington, DC

  • Education
  • The Americas

Overview

Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal when compared to aseptic manufacturing. These include the handling and evaluation of non-sterile components, the environment and final product.

This training course discusses various regulations and how they impact non-sterile manufacturing to include the setting of specifications, development of processes, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Thoughts regarding in-house microorganisms that may be considered as “specified” will also be discussed. A case study will be included where teams will discuss some of the various regulatory issues that are encountered in a plant environment and report their findings to all of the participants.

Participants will benefit having a basic background in the sciences including biology (microbiology) or chemistry, and having basic familiarity with various regulations to include: 21 CFR 211, FDA Guidance documents, EMA and Health Canada guidance, and/or ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – ICH Harmonized Tripartite Guideline, November 2000.

For more options and/or related training courses, please visit the page(s) below.

PDA Quality Control/Analytical Training Courses
PDA Annual Global Conference on Pharmaceutical Microbiology Training Courses

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

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

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify microbiological regulatory concerns with non-sterile incoming components, in-process, active pharmaceutical ingredients (API) and finished product
    2. Discuss key microbiological issues involved in the manufacturing of non-sterile products
    3. Review the establishment of a non-sterile microbiological control program
    4. Identify gaps with current regulatory and industry expectations
    5. Explain how USP<1115>, Bioburden Control of Non-Sterile Drug Substances and Products, complements the development of non-sterile products
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who need an understanding of regulatory aspects related to non-sterile microbiology.

    Departments
    Quality Assurance, Quality Control, Manufacturing

    Roles
    Specialist, Analyst, Supervisor, Manager

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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.

Grand Hyatt Washington

1000 H St NW
Washington, DC

  • 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 Grand Hyatt Washington. The rate is $299 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 21, 2020. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Grand Hyatt Washington at +1 (202) 582-1234. Be 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 3 days in advance of arrival unless 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

The Grand Hyatt Washington is located at 1000 H Street NW, Washington, DC 20001.

Self-Parking: $42 per day
Valet Parking: $62 per day

Other Options

The Hotel lobby is connected to the Metro Center Metro Station. Metro fare from Reagan National Airport (DCA) is $2.30 (one-way; Blue Line).

Directions

Registration Fees

Early Registration
Registration Type Price By September 7, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979
Regular Registration
Registration Type Price After September 7, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* 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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