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Exclusion of Objectionable Microorganisms from Pharmaceutical and OTC Drug Products

Oct 25, 2019
Rockville, MD

  • Education
  • The Americas

Overview

This training course, derived from the work of the PDA Objectionable Microorganism Task Force, covers the exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products, over-the-counter drug products, medical devices, cosmetics and personal care products in the Pharmaceutical, Medical Device, Cosmetics and Consumer Healthcare Industries. Objectionable microorganisms, as cited in 21 CFR 211.113, are those microorganisms that, if they persist and grow in non-sterile products, can cause harm to the user of the products and degrade the physicochemical, functional and therapeutic attributes of the products. The contamination of marketed products with so-called objectionable microorganisms continues to be an infrequent but chronic problem for both regulators and our industry.

This training course will provide guidance on how to manage the microbial risks associated with objectionable microorganisms within a specific product that meet the microbial limit requirements for release to the market. No definitive list of objectionable microorganisms will be provided in this training course, but microorganisms of potential concern will be highlighted from the literature regarding product contamination, infection outbreaks, product recalls, and the clinical experience with canonical pathogens and other opportunistic microorganisms at the site of administration of the non-sterile product. Attention will be given to the proposed USP chapter <60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex. Risk mitigation including ingredient selection, the effect of unit manufacturing processes on product bioburden, environmental controls, product formulation, microbial specification setting, release and stability testing, risk assessment and product failure investigation will be highlighted using recent industry case histories.

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

Tony Cundell
Tony Cundell
Microbiological Consulting, LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the regulatory requirements surrounding objectionable microorganisms
    2. Conduct risk assessments for ingredients, packaging components, product design and formulation, manufacturing processes, facility design and product testing to address the exclusion of objectionable microorganisms
    3. Conduct risk assessments to determine if microorganisms found in a specific product are objectionable
    4. Develop risk-based microbiological specifications and testing programs that address a range of products
    5. Establish a corporate objectionable microorganism policy
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are responsible for contamination control and microbiology programs for drug manufacturing.

    Departments
    Quality Control, Quality Assurance, Regulatory Affairs

    Roles
    Analyst, Supervisor, Manager

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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

Make a Reservation
  • 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 Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Sep 25, 2019, no fee will be charged. After Sep 25, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Sep 25, 2019, a full refund will be given minus a $200 fee. After Sep 25, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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