Technical Report No. 67: Exclusion of Objectionable Microorganisms from Pharmaceutical and OTC Drug Products

Washington, DC
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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.

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

  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

Standard Registration

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See Qualifying Criteria for Member Types.

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].

Day 1

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

Agenda is subject to change.

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.

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.

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