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.
- Discuss the principles and best practices of microbial control in pharmaceutical processes based on current best practices and regulatory expectations
- Discuss the biology underlying bioburden development in pharmaceutical and biopharmaceutical drug substance production systems
- Explain the mechanisms surrounding biofilm formation and the complex interactions between that exist between planktonic and sessile modes of microbial contamination
- Present information on typical control levels/limits for various types and stages of biopharmaceutical production systems, including critical utility systems
- 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
Early Bird Pricing
Early Bird Member Price$1,259
Health AuthorityMember Only
Standard Member Price$1,399
Health AuthorityMember Only
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].
Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.
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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 Washington1000 H St NW
Washington, DC , United States
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.
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.