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Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations

Oct 22, 2020
Washington, DC

  • Education
  • The Americas

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Overview

This training course will provide scientific understanding and real-world practices for the management of bioburden and biofilm in pharmaceutical and biopharmaceutical production processes. Microbial control of pharmaceutical API and biopharmaceutical drug substance or API production processes is a significant quality and compliance problem today.

Major topics include the following:

  • Mechanisms surrounding biofilm formation and the complex interactions that exist between planktonic and sessile modes of microbial contamination
  • Principles and best practices in the design of facilities, utilities, and equipment to minimize bioburden with emphasis on biofilm control
  • Proven practical approaches to preventing bioburden and biofilm using real word examples
  • Typical control levels for various types and stages of biopharmaceutical production including critical utility systems
  • Best current available technology and sampling practices for bioburden and biofilm detection, including trend analysis and decision principles within the quality management system

Consistent with PDA’s Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations, best practices for remediation of contaminated processes and equipment will be reviewed with case studies in remediation where possible. The case studies will provide lessons learned in effective quality investigations and regulatory interactions once problems occur. The training course will present practical approaches to the prevention, detection, and remediation of microbial contaminations that students can use in daily production and laboratory operations.

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

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

Trainers

Marc Mittelman
Marc Mittelman
Mittelman and Associates, LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss the principles and best practices of microbial control in pharmaceutical processes based on current best practices and regulatory expectations
    2. Discuss the biology underlying bioburden development in pharmaceutical and biopharmaceutical drug substance production systems
    3. Explain the mechanisms surrounding biofilm formation and the complex interactions between that exist between planktonic and sessile modes of microbial contamination
    4. Present information on typical control levels/limits for various types and stages of biopharmaceutical production systems, including critical utility systems
    5. Explain the principles and best practices in prevention, detection, and remediation of microbial contamination in pharmaceutical/biopharmaceutical drug substance or API production systems, including current regulatory guidance and expectations
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in biofilm management.

    Departments
    Engineering, Facilities, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Research and Development

    Roles
    Director, Manager, Operator, Scientist, Specialist, Supervisor, Technician

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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

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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 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 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 Oct 08, 2020, no fee will be charged. After Oct 08, 2020, 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 Oct 08, 2020, a full refund will be given minus a $200 fee. After Oct 08, 2020, 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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Tel: +1 (301) 656-5900 ext. 115
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